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Phase III Trial of Concurrent Chemoradiation With or Without Atezolizumab for Localized Muscle Invasive Bladder Cancer: SWOG/NRG Intergroup Trial (S1806)
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S1806 Agenda 1. Introduction 2. Protocol Overview: Study Objectives
Inclusion/Exclusion Criteria Enrollment Goals Visit Schedule Study Procedures 3. Translational Medicine & Bio-Banking 4. Patient Perspective 5. Monitoring & Auditing 6. Investigator Responsibilities 7. Questions and Answers
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Introductions Parminder Singh Josh Meeks Sameer Jhavar Amit Gupta
Melissa Plets
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S1806 SWOG Study Team Principal Investigators
Parminder Singh, M.D. (Medical Oncology) Mayo Clinic Arizona Phone: 480/ Seth Lerner, M.D. (Urology) Scott Department of Urology Baylor College of Medicine Phone: 713/ Sameer Jhavar, M.D., Ph.D. (Radiation Oncology) Baylor Scott and White Phone: 254/ Fax: 254/ Add Scott Lucia - Pathology
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S1806 SWOG Study Team Gretchen Goetz SWOG Operations Office
Protocol Coordinator Gretchen Goetz SWOG Operations Office Biostatisticians SWOG Statistics and Data Management Center Fred Hutchinson Cancer Research Center Cathy Tangen, Dr.P.H. (Biostatistics) Joseph Unger, Ph.D. (Biostatistics, Quality of Life) Melissa Plets, M.S. Data Coordinator Joseph Sanchez Add Scott Lucia - Pathology
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Team Members from Intergroup
NRG ( Study Chair) : Jason Efstathiou, MD., D. Phil Massachusetts General Hospital Department of Radiation Oncology Phone: 617/ Fax: 617/ ECOG-ACRIN Champion : Noah Hahn , M.D. ALLIANCE Champion : Brian Costello, M.D, M.S. CCTG Champion : Srikala Sridhar, M.D. M.Sc., FRCP
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Translational Medicine Team
SWOG: Josh Meeks, M.D., PhD NRG: Felix Feng, M.D. ECOG-ACRIN: Petros Grivas M.D. PhD ALLIANCE: Bishoy Faltas, M.D. QOL Team SWOG: Amit Gupta, M.D. ALLIANCE/NRG: Ronald Chen, M.D. ECOG: Alicia Morgans, M.D., M.P.H
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1(Gray, Fedewa et al. 2013),2(Grossman, Natale et al. 2003)
Background Analysis of 28,000 new patients with bladder cancer T2- T4a(NCDB) showed that only 52% received aggressive therapy1. Standard of care is Neoadjuvant cisplatin based chemotherapy f/b radical cystectomy2. Experience from S1011 shows only 45% patients are receiving neoadjuvant chemotherapy. AUA/ ASCO/ NCCN guidelines recommend bladder preservation using tri-modality therapy as an option for patients refusing radical cystectomy or are ineligible for radical cystectomy. 1(Gray, Fedewa et al. 2013),2(Grossman, Natale et al. 2003)
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Chemoradiation for Muscle Invasive Bladder Cancer
Evidence is slowly accumulating that chemo radiation is a good alternative with long term outcomes approaching what is observed in chemo followed by surgery clinical trials. But still there is clearly room for improvement with 5 year OS around 52%.
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Rationale for Combining Immunotherapy with Concurrent Chemoradiation (CRT)
CRT is standard of care of patients opting for bladder preservation in MIBC1-4,8 Immunotherapy is already approved in locally advanced and metastatic bladder cancer5-7 Radiation upregulated the expression of PD-L1 in tumor cells in a dose dependent fashion8 Concurrent radiation and PD-1 inhibitor show augmented response in mouse model9 Combined chemotherapy and PD-1 inhibitor is already approved treatment option in lung cancer10 Trials investigating combination of CRT and IO in localized muscle invasive bladder cancer are in phase I and II There is growing evidence that PD-L1 expression has role in response to immunotherapy for urothelial carcinoma . Studies had previously shown that radiation upregulated the expression of PD-L1 in tumor cells in a dose dependent fashion. Combined chemo immuno strategy is approved in lung cancer and studies exploring concurrent chemoimmunoand RT has not observed any significant increase in toxicity. Smaller phase II trials in bladder cancer which are ongoing have not seen any increase toxicity in the patients who are enrolled. 1: Hussain et al. 2012; 2: Shipley et al. 2017; 3: Hunt et al. 2014; 4:Kulkarni. JCO, 2017; 5. Retz et al. 2017; 6: de Wit et al. 2017; 7: Hoffman-Censits et al. 2016; 8: Chen et al. 2016; 9: NCCN guideline; 9: See et al. 2013; 10: Gadgeel et al. 2016
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Hypothesis Checkpoint inhibitors will improve the efficacy of concurrent chemo-radiation therapy (CRT) for localized muscle invasive bladder cancer. So our working hypothesis is that check point inhibitors will improve the efficacy of concurrent chemo-radiation therapy (CRT) for localized muscle invasive bladder cancer
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Clinical response at 5 mths CRT(concurrent chemoradiation)
Schema and Objectives Primary end point BIEFS* Secondary end point OS at 5 yr Clinical response at 5 mths DSS MFS Toxicity at 1& 2 yr NMIBC rec Cystectomy rate Global Qol TM end points MRE 11 DDR Immune markers CRT(concurrent chemoradiation) cT2-T4N0M0 stratify by Chemotherapy regimen Radiation field Performance status Clinical stage Randomize 1:1, 475 patients Study schema is very simple patients with T2-T4 No M0 are stratified based on chemo regimen, radiation field, performance status and clinical stage and randomised to chemoRT vs chemo CRT+ Atezo x9 *BIEFS (bladder intact event free survival) includes: muscle invasive recurrence in the bladder, regional pelvic soft tissue or nodal recurrence, distant metastases, bladder cancer or toxicity related death or cystectomy
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Key Inclusion/Exclusion Criteria
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Key Eligibility Clinical T2-T4a N0M0 with primary urothelial carcinoma (mixed histology allowed but small cell carcinoma excluded). Patients must undergo a pelvic exam under anesthesia (with the findings and clinical stage recorded in the operative report) and TURBT within 70 days prior to randomization. The exam helps in excluding patient who are T4b. Patients with unilateral hydronephrosis are eligible if their kidney function permits enrollment on the study. ECOG performance status 0-2. GFR >25 mL/min, Hb >9 gm/dL.
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Key Eligibility Allow HIV, HBV, and HCV patients if meet certain lab criteria. Previous malignancy outside 2 year are allowed. Patients with hydronephrosis are eligible if they have unilateral hydronephrosis and kidney function meets criteria specified in protocol.
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Important Exclusions Patients must NOT have/had…
Diffuse CIS. UC at any site outside of the urinary bladder within the previous 2 years except Ta/T1/ (CIS) of the upper urinary tract if the patient had undergone complete nephrouretrectomy. prior pelvic radiation. received prior treatment for muscle invasive bladder cancer. received any systemic therapy (including, but not limited to, interferon alfa-2b, high dose IL-2, PEG-IFN, anti-PD-1, anti- PD-L1), for non-muscle invasive bladder cancer. Standard exclusions for immunecheckpoint inhibitors.
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Statistical Design and Enrollment Goals
Melissa Plets
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Primary Endpoint Bladder intact event-free survival (BI-EFS)
Event components: Histologically proven presence of muscle- invasive bladder cancer, clinical evidence of nodal or metastatic disease, radical cystectomy, or death due to any cause. From date of randomization to the first documentation of a BI- EFS event. Patients last known to be BI-EFS event-free are censored at the date of last cystoscopy. Those patients without disease assessment who are still alive will be censored at randomization.
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Secondary Clinical Endpoints
Overall Survival: From date of randomization to date of death due to any cause. Patients last known to be alive are censored at the date of last contact. Modified Bladder-intact event-free survival (mBI-EFS) Biopsy Response at 18 weeks : Complete response vs. down-staging vs. no response Complete Response duration Progression-free Survival Metastasis-free Survival
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Stratification Factors
Clinical Stage: T2 vs. T3/T4a Intended Chemotherapy Regimen: cisplatin vs. 5-FU + mitomycin-C vs. gemcitabine Radiation Field: Small pelvis vs. Bladder only Performance Status: 0-1 vs. 2
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Statistical Design Primary endpoint: BI-EFS H0= 52% (at 3 yrs)
HA = 64% (at 3 yrs) 85% power, 1-sided α=0.025 Randomize: 1:1 (CRT vs CRT+ atezolizumab) Sample size: n=475 total (432 eligible + 10% ineligible) Four formal interim analyses to test efficacy and futility Approx. 3, 4, 5 and 6 years after first patient randomized (determined by number of observed BI-EFS events Enrollment 8-12/month Accrual 4 years Completion 7 years
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Data Submission and Study Visit Schedule
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Prior to Registration Eligibility Criteria Form
Completed, Signed, & Dated by registering investigator after patient consent but prior to registration. Scan in as baseline source doc in Rave. Enter answers electronically in Rave.
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Registration/Randomization
TWO Registration Steps Reg step 1 Reg step 2 Submit pre-RT planning docs via TRIAD within 3 days of registration on S1806 Submit RT plan docs via TRIAD within 7 days after start of RT Continue to step 2 on same day registered to step 1
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Treatment Schedule “CYCLE” = 21 days
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Treatment Schedule Atezolizumab (arm 2 only) continues for up to 6 additional doses, (total of 9 doses).
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Disease Assessment Schedule
Starting at week 18 following randomization: Cystoscopy & Urine Cytology q 12 wks for 2 yrs; q 6 mos for yrs 3-5 Mandatory Biopsy At week 18 (± 14 days) Must submit tissue for central path review CT/MRI q 12 wks for 1 yr; q 6 mos for yrs 2-3; q 12 mos for yrs 4-5 SUBMIT ALL SCAN IMAGES VIA TRIAD
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Disease Assessment Schedule
Submit tissue from mandatory biopsy Submit all images via TRIAD
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Quality of Life Questionnaires
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Safety Cohort Weekly AE monitoring for first 40 patients in each arm for first two cycles (6 weeks). If 25% or more of the first 40 evaluable patients on the experimental arm experience Grade 3 or higher colitis or other possibly immune-related toxicities, then consideration will be given to re- evaluating the safety and feasibility.
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Study Procedures
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Treatment Plan Arm 1- Chemo Radiation only Gemcitabine 27 mg/m2 IV OR
Twice weekly for six weeks OR Cisplatin 35 mg/m2 IV Weekly for six weeks 5-FU 500 mg/m2 IV given on same days as doses 1-5 and of RT Mitomycin-C 12 mg/m2 IV given on same day as dose 1 of RT
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Arm 2- Chemo- radiation + Immunotherapy
Atezolizumab 1200 mg IV Q 21 days x 9 cycles Plus either Gemcitabine 27 mg/m2 IV Twice weekly for six weeks OR Cisplatin 35 mg/m2 IV Weekly for six weeks 5-FU 500 mg/m2 IV given on same days as doses 1-5 and of RT Mitomycin-C 12 mg/m2 IV given on same day as dose 1 of RT
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Radiation Therapy Sameer Jhavar
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Radiation
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Radiation
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Radiation Therapy Small Pelvis (PTVsp) 40-50 Gy/20-25 Fxs Gy/23-28 Fxs Option a Whole Bladder (PTVwb) Gy/3-6 Fxs Gy/3-7 Fxs Bladder Tumor (PTVbt) Gy/4-6 Fxs Gy/5-6 Fxs Option b Gy/7-12 Fxs Gy/8-13 Fxs Option c Treatment intent: Include initial small pelvic fields to treat pelvic nodes
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Radiation Therapy Treatment intent: Initial small pelvic fields (to treat pelvic nodes) excluded
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Radiation Therapy Normal Structure Constraints and Compliance Criteria
Name of Structure Dosimetric parameter Per Protocol Variation Acceptable Rectum V30Gy[%] <=50% <=55% V55Gy[%] <=10% <=15% Femoral_Head_L Femoral_Head_R D0.03cc[Gy] <=50 Gy <=55 Gy V45Gy[%] Bowel_Small <=57.5 Gy V50Gy[cc] <=15 cc <=20 cc V45Gy[cc] <=100 cc <=120 cc V40Gy[cc] <=130 cc <=150 cc V40Gy[%] <=30% <=35% V30Gy[cc] <=170 cc
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Radiation Therapy Protocol radiation therapy must start within 7 days following randomization. Pre-Treatment review of the first case for each modality (3DCRT/IMRT) registered by each institution is required PRIOR TO DELIVERY of radiation treatment. The patient will not be randomized until they have received approval from the Imaging and Radiation Oncology Core (IROC)-Philadelphia RT. The Pre-Treatment Review process requires 3 business days from the receipt of complete data to TRIAD. If an unacceptable deviation occurs the next case may require a Pre-Treatment review. Per Protocol Variation Acceptable Registration to RT Start date 7 days n/a Interruptions <=3 days 4<=7 days
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Disease Assessments With the exception of those with metastatic disease with absence of recurrence in the bladder, all patients are required to undergo re- resection of the tumor bed 18 weeks (± 14 days) after registration. Sites are required to submit biopsy specimen (and corresponding pathology report) performed at this evaluation, regardless of results, for central pathology review. Patients who achieve a CR or only residual NMIBC: will undergo cystoscopic and cytologic monitoring and for-cause biopsies every 3 months for the first two years, then every six months for Years 3-5. Patients will undergo CT or MRI of the chest/abdomen/pelvis around Weeks 18, 30, 42, and 54, then every six months for two years, then annually for two years. The images of these scans must be submitted to IROC via TRIAD. If patients undergo biopsy of the metastatic site then biopsy should be submitted.
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Quality of Life (QOL) Hypothesis: Global quality of life is improved in the intervention arm due to improved disease control (reduced recurrence).
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Instruments to be Included
EORTC QLQ-C30 and QLQ-BLM30: validated questionnaire for muscle invasive bladder cancer. Expanded Prostate Cancer Index (bowel domain only): to supplement questions related to potential bowel symptoms. EQ5D-5L: this is a validated instrument that will capture an assessment of overall health state, or utilities. This allows an analysis of quality-adjusted survival for the overall trial.
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Translational Medicine
Josh Meeks
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Integrated Translational Medicine
Chemoradiotherapy+ atezolizumab Cysto/TURBT/ cytology/CT or MRI Primay -BIDFS at 3 yrs MIBC T2-T4aN0M0 5 mths post registration Chemoradiotherapy Blood and Urine (banked) Tissue (objectives 1 and 2) Blood and Urine (banked) Tissue (banked) Objective 1: DNA Damage response associated with improved Bladder Intact-Disease Free Survival MRE11 IHC Nuclear/Cytoplasmic Ratio DDR mutations (ERCC2, ATM, BRCA1/2, FANCC Objective 2: Immune Response enhanced with Atezolizumab treatment Neoantigens TMB PDL1, CD8+ IHC TruCulture
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Nucleotide for germline DNA
RNA-Seq Subtyping Path WES DDR TUR 20 slides Nucleic Acids TMB Neo-antigen MRE11 Decipher PDL-1 CD8 TruCulture Blood banking Nucleotide for germline DNA Microbiome* *to be added
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S-1806 Study Schema BIDFS Chemoradiotherapy
+ atezolizumab *Cystoscopy / TURBT and cytology, CT/MRI MIBC T2-T4aN0M0 Randomized BIDFS CR or NMIBC MIBC Chemoradiotherapy 3 years Tissue FFPE from tumor Blood (Germline DNA) The trial design is illustrated here……pause …. Patients with MIBC (T2-T4aN0M0) will be stratified based on predefined criteria. They will receive either physician choice chemotherapy and concurrent radiotherapy( CRT). Radiation dose will be standard protocol with permissive design to allow for lymph node radiation . Patients will be randomized to either receive or not receive atezolizumab in addition to their chemo-radiation for a total of 6 months. Patients on atezolizumab arm may receive additional doses after cystoscopy to complete 6 months treatment duration if they have a CR or only residual NMIBC at the first disease evaluation. Response will be assessed with cytology, cystoscopy and TURBT including muscularis propria of the tumor bed 5 months after registration. If the patient has persistent MIBC or progression, they will be taken off atezolizumab treatment and proceed with physician choice appropriate next line of therapy which may include cystectomy. Patients who achieve a CR or only residual NMIBC will undergo cystoscopy, cytology and for cause biopsies if indicated every three months for one year, every 6 months in the second and third year , and annually for up to 5 years. These patients can receive intravesical therapies if appropriate. CT/MRI of the chest/abdomen/pelvis will be performed every 3 months for first 6 months and then every 6 months there after for 3 years, and annually thereafter till year 5 Total Mutation Burden (TMB) DNA Damage Repair Mutations Expression-Based Molecular Subtyping
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Total Mutation Burden The trial design is illustrated here……pause …. Patients with MIBC (T2-T4aN0M0) will be stratified based on predefined criteria. They will receive either physician choice chemotherapy and concurrent radiotherapy( CRT). Radiation dose will be standard protocol with permissive design to allow for lymph node radiation . Patients will be randomized to either receive or not receive atezolizumab in addition to their chemo-radiation for a total of 6 months. Patients on atezolizumab arm may receive additional doses after cystoscopy to complete 6 months treatment duration if they have a CR or only residual NMIBC at the first disease evaluation. Response will be assessed with cytology, cystoscopy and TURBT including muscularis propria of the tumor bed 5 months after registration. If the patient has persistent MIBC or progression, they will be taken off atezolizumab treatment and proceed with physician choice appropriate next line of therapy which may include cystectomy. Patients who achieve a CR or only residual NMIBC will undergo cystoscopy, cytology and for cause biopsies if indicated every three months for one year, every 6 months in the second and third year , and annually for up to 5 years. These patients can receive intravesical therapies if appropriate. CT/MRI of the chest/abdomen/pelvis will be performed every 3 months for first 6 months and then every 6 months there after for 3 years, and annually thereafter till year 5 From Mariathasan et al, Nature March 2018 From Powles et al GU ASCO 2018 ”Positive Biomarker” defined by a TMB of 12.2 mutations/MB in UC found in top 30% of IMVigor 210 and 211 12.2 mutations/MB chosen because of the best response in IMVigor 211 HR of year BIDFS
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Expression Based Molecular Subtyping
”Positive Biomarker” defined by a Subtype of Luminal Infiltrated (k=4) or GU Unstable in Lund found in 20% of Single-patient classifier validated and near publication, ready for clinical application The trial design is illustrated here……pause …. Patients with MIBC (T2-T4aN0M0) will be stratified based on predefined criteria. They will receive either physician choice chemotherapy and concurrent radiotherapy( CRT). Radiation dose will be standard protocol with permissive design to allow for lymph node radiation . Patients will be randomized to either receive or not receive atezolizumab in addition to their chemo-radiation for a total of 6 months. Patients on atezolizumab arm may receive additional doses after cystoscopy to complete 6 months treatment duration if they have a CR or only residual NMIBC at the first disease evaluation. Response will be assessed with cytology, cystoscopy and TURBT including muscularis propria of the tumor bed 5 months after registration. If the patient has persistent MIBC or progression, they will be taken off atezolizumab treatment and proceed with physician choice appropriate next line of therapy which may include cystectomy. Patients who achieve a CR or only residual NMIBC will undergo cystoscopy, cytology and for cause biopsies if indicated every three months for one year, every 6 months in the second and third year , and annually for up to 5 years. These patients can receive intravesical therapies if appropriate. CT/MRI of the chest/abdomen/pelvis will be performed every 3 months for first 6 months and then every 6 months there after for 3 years, and annually thereafter till year 5 From Mariathasan et al, Nature March 2018
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J.R. Laurberg et al BJU Int. , 2012
MRE11: A promising predictive biomarker of response to radiation-based bladder preservation approaches 30% 30% J.R. Laurberg et al BJU Int. , 2012 In retrospective single institution cohorts, MRE11 expression has been shown to predict disease-specific survival in response to bladder preservation strategies, but not surgery.
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The Patient Perspective
Rick Bangs
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Patient Perspective S1806 Bladder and sexual function preservation
The “Holy Grail” Underserved Vs. compliance to neoadjuvant chemotherapy standard-of-care Requires acceptable bladder function Tumor is not being completely removed 10-30% I/O success rate (but builds on chemoradiation success) Safety of immune checkpoint inhibitors in combination with chemoradiation plus side effects Radiation impact on urinary diversion choice Logistical burden Financial toxicity Important but new endpoint (Bladder intact event-free survival)
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Auditing Elaine Armstrong
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S1806 Elaine Armstrong, M.S. Central Monitoring On-site Monitoring
Investigator Responsibilities Elaine Armstrong, M.S.
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SWOG Quality Assurance Program (SWOG Policy 19)
Program Purpose Verify compliance with protocol and regulatory requirements. Verify adherence to NCI/SWOG policies and procedures. Verify data reported on eCRFs accurately reflect source documents. Provide educational support related to GCP, data collection and data management.
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Quality Assurance Audit Process
Standard SWOG Audit Process Routine audit every 3 years 10% accrual randomly selected Case selection includes: SWOG, CTSU and Cancer Control accrual Safety monitoring through routine review of adverse event reports to assess for accuracy and timeliness of SAE reporting
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What’s Different for S1806 Mandatory training of key site personnel prior to 1st patient registration. Additional mandatory training if major protocol changes or common problem areas identified during monitoring and audits. Off-site centralized monitoring of first two patients per site. More timely and more frequent on-site auditing.
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What’s Different for S1806 Trial Master File Delegation of Task Log
Assessment of communication between monitors, Data and Safety Monitoring Committee, and site staff to assess potential problem areas, provide feedback, identify staff turnover, etc.
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QA/On-Site Monitoring Process for S1806
First site visit within 6 months of first patient randomization. Subsequent visits dependent on accrual but no less than once every 2 years. Site visits combined with routine treatment audits or other registration trial site visits when possible to reduce impact on site staff.
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Reasons for More Frequent On-Site Monitoring
Inadequate initial on-site monitoring results Problems identified through off-site monitoring Deficient or delinquent data submission Higher than expected SAE reporting or ineligible cases Excessive staff turnover
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What to Expect at an On-site Monitoring Visit
Regulatory requirements IRB approvals Consent form content Trial Master File Delegation of Task Log Investigational drug accountability Review of drug accountability records On site visit to pharmacy
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What to Expect at an On-site Monitoring Visit
Patient Case Review Consent Form Eligibility Treatment Disease assessment Toxicity Assessment Data Quality
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Your Responsibility During an On-Site Monitoring Visit
Source documents ready for review – organized, flagged EMR password issued to auditor(s) if allowed per your institution SOPs Scheduled time to visit pharmacy Availability to answer questions Availability for monitoring summary/exit interview
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QA/Audit Program Resources on SWOG Website
Links to Guidelines SWOG Policy 19 SWOG QA Audit Guidelines NCI-CTMB Guidelines for Monitoring Clinical Trials Links to Regulatory Guidance Human Subjects Protection SWOG Regulatory Guidance IRB Implementation Dates FDA Inspections (Trial Master File Document)
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Who to Contact for S1806 QA/On-Site Monitoring Questions
Elaine Armstrong, M.S. (210) OR
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Central Monitoring Dona Marrah
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SDMC Risk-based Monitoring for S1806
More monitoring is required on Registration Trials! In addition to SWOG audits, the Statistics and Data Management Center (SDMC) Central Monitors will be conducting Source Documen.t Verification (SDV)
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Source Document Verification Process for Centralized Monitoring
Head CRA notification via for source document upload instructions into the Source Document Portal (SDP) on CTSU website. First two patients randomized to treatment at each site will be centrally monitored. Source Document Verification will include auditable elements* for the following: Eligibility Consent Activities for cycles 1 and 2 Disease assessment at week 18 Quality of Life Questionnaires from weeks 12 & 18 * See Central Monitoring Handout for more details
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CTSU Portal for Uploading Source Documents for Central Monitoring
Sites have access to the SDP via a link in Rave® or directly by logging into the CTSU website to upload source documents. A redacting tool within the CTSU portal has the ability to redact PHI and it also automatically populates the documents with the patient ID#.
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Access via Rave Access via CTSU Source Document Portal
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Data Coordinator Review at the Statistics and Data Management Center (SDMC)
Routine review of submitted data for ALL patients (Not just the 2 patients selected for SDV by the central monitors). Remote verification of critical source documents that are uploaded into Rave identified in Section 14.4c: Eligibility Criteria Form, Operative and Pathology Reports, all Radiology Reports from Scans performed to assess disease at baseline & Section 14.4.i&j: Pathology report from mandatory biopsy, Cystoscopy report, Urine cytology report, Radiology reports from all scans performed to assess disease. Analysis of site characteristics and performance metrics to identify trial sites with poor performance or non-compliance through the SWOG IPR and other available reports. Review timeliness of SAE reporting. Review timeliness of data submission. Verification of specimen submission.
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Who to Contact for Questions Related to Central Monitoring for S1806?
Dona Marrah, CCRP
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Questions?
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