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Trial Evaluating 3-year Disease Free Survival in Patients With Locally Advanced Rectal Cancer Treated With Chemoradiation Plus Induction or Consolidation Chemotherapy and Total Mesorectal Excision or Non-operative Management

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ClinicalTrials.gov Identifier: NCT02008656
Recruitment Status : Active, not recruiting
First Posted : December 11, 2013
Last Update Posted : September 13, 2021
Sponsor:
Collaborators:
Colon and Rectal Surgery Inc.
The Cleveland Clinic
John Muir Health
Oregon Health and Science University
St. Joseph Hospital of Orange
University of California, Irvine
University of California, San Francisco
University of Chicago
University of South Florida
University of Vermont
University of Washington
Medstar Health Research Institute
Washington University School of Medicine
Creighton University Medical Center
The Methodist Hospital Research Institute
University of Rochester
University of Virginia
St. Paul's Hospital
St. Joseph, Florida
Cleveland Clinic Florida
University of Colorado, Denver
University of Michigan
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE November 27, 2013
First Posted Date  ICMJE December 11, 2013
Last Update Posted Date September 13, 2021
Actual Study Start Date  ICMJE November 2013
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2013)
disease-free survival (DFS) [ Time Frame: 3 years ]
3-year DFS will be defined as the percentage of patients alive without recurrence of disease at 3 years measured from the date of randomization
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2013)
major adverse events [ Time Frame: 3 years ]
Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial Evaluating 3-year Disease Free Survival in Patients With Locally Advanced Rectal Cancer Treated With Chemoradiation Plus Induction or Consolidation Chemotherapy and Total Mesorectal Excision or Non-operative Management
Official Title  ICMJE A Phase II Multicenter Randomized Trial Evaluating 3-year Disease Free Survival in Patients With Locally Advanced Rectal Cancer Treated With Chemoradiation Plus Induction or Consolidation Chemotherapy and Total Mesorectal Excision or Non-operative Management
Brief Summary The study is designed to test the hypothesis that patients with Locally advanced rectal cancer ( LARC) treated with Total neoadjuvant therapy (TNT) and Total mesorectal excision (TME) or Non-operative management (NOM) will have an improved 3-year disease-free survival (DFS) compared to patients with similar tumors treated with Chemoradiation therapy (CRT), Total mesorectal excision (TME) and Adjuvant chemotherapy (ACT).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rectal Cancer
Intervention  ICMJE
  • Drug: Oxaliplatin (OXAL)
  • Drug: 5-Fluorouracil (5-FU)
  • Drug: Leucovorin
  • Drug: Capecitabine (Xeloda®)
  • Radiation: intensity modulated radiotherapy (IMRT)
  • Behavioral: Quality of Life Questionnaires
  • Procedure: DRE-Endoscopy
Study Arms  ICMJE
  • Experimental: INCT
    Arm 1 will receive chemotherapy before chemoradiation. This is called induction neoadjuvant chemotherapy arm (INCT). The neoadjuvant chemotherapy regimen is prescribed specifically as 8 cycles of FOLFOX or 5 cycles of CapeOX over a period of approximately 15-16 weeks. Endoscopic exam (2-4 wks) after chemotherapy. If stable or response then pt will have radiation with either 5-FU or capecitabine.
    Interventions:
    • Drug: Oxaliplatin (OXAL)
    • Drug: 5-Fluorouracil (5-FU)
    • Drug: Leucovorin
    • Drug: Capecitabine (Xeloda®)
    • Radiation: intensity modulated radiotherapy (IMRT)
    • Behavioral: Quality of Life Questionnaires
    • Procedure: DRE-Endoscopy
  • Experimental: CNCT
    Arm 2 will receive chemoradiation before chemotherapy This is called the consolidation neoadjuvant chemotherapy arm (CNCT). Pt will have 6 weeks of chemoradiation therapy. Along with the radiation the pt will receive either 5-FU or capecitabine. 2-4 weeks after pt will have endoscopic exam and if stable or response pt will have will have 8 cycles of FOLFOX or 6 cycles of CapeOX.
    Interventions:
    • Drug: Oxaliplatin (OXAL)
    • Drug: 5-Fluorouracil (5-FU)
    • Drug: Leucovorin
    • Drug: Capecitabine (Xeloda®)
    • Radiation: intensity modulated radiotherapy (IMRT)
    • Behavioral: Quality of Life Questionnaires
    • Procedure: DRE-Endoscopy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 10, 2020)
358
Original Estimated Enrollment  ICMJE
 (submitted: December 6, 2013)
222
Estimated Study Completion Date  ICMJE November 2022
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed diagnosis of adenocarcinoma of the rectum
  • Clinical Stage II (T3-4, N-) or Stage III (any T, N+) based on MRI
  • Rectal tumor at baseline which would be considered to require complete TME
  • No evidence of distant metastases
  • No prior pelvic radiation therapy
  • No prior chemotherapy or surgery for rectal cancer
  • Age ≥ 18 years The minimum legal age of consent for select Canadian provinces is 19
  • No active infections requiring systemic antibiotic treatment (oral antibiotics are acceptable at the discretion of the treating physician)
  • ECOG Performance status 0-2
  • Women with childbearing potential (WOCBP) who are negative for pregnancy test (urine or blood) and who agree to use effective contraceptive method. A woman of childbearing potential is defined of one who is biologically capable of becoming pregnant. Reliable contraception should be used from trial screening and must be continued throughout the study.
  • Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study. Patients who do not read or understand English are eligible and may be consented according to institutional and federal regulations.
  • ANC > 1.5 cells/mm3, HGB > 8.0 gm/dl, PLT > 150,000/mm3 total bilirubin ≤ 1.5 x ULN (except in patients with Gilbert's Syndrome who must have total bilirubin ≤ 3.0 x ULN), AST≤ 3 x ULN, ALT ≤ 3 x ULN.

Exclusion Criteria:

  • Recurrent rectal cancer
  • Primary unresectable rectal cancer. A tumor is considered unresectable when invading adjacent organs and an en block resection will not achieve negative margins.
  • Creatinine level greater than 1.5 times the upper limit of normal.
  • Patients who have received prior pelvic radiotherapy.
  • Patients who are unable to undergo an MRI.
  • Patients with a history of any arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), MI, TIA, or CVA.
  • Patients with a history of venous thrombotic episodes such as deep venous thrombosis, pulmonary embolus occurring more than 6 months prior to enrollment may be considered for protocol participation, provided they are on stable doses of anticoagulant therapy. Similarly, patients who are anticoagulated for atrial fibrillation or other conditions may participate, provided they are on stable doses of anticoagulant therapy.
  • Other Anticancer or Experimental Therapy. No other experimental therapies (including chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, matrix metalloprotease inhibitors, thalidomide, anti-VEGF/Flk-1 monoclonal antibody or other experimental drugs) of any kind are permitted while the patient is receiving study treatment.
  • WOCBP who are unwilling or unable to use an acceptable method of avoiding pregnancy for the entire study period.
  • Women who are pregnant or breast-feeding.
  • Patients with any other concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this study.
  • Patients with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02008656
Other Study ID Numbers  ICMJE 13-213
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE
  • Colon and Rectal Surgery Inc.
  • The Cleveland Clinic
  • John Muir Health
  • Oregon Health and Science University
  • St. Joseph Hospital of Orange
  • University of California, Irvine
  • University of California, San Francisco
  • University of Chicago
  • University of South Florida
  • University of Vermont
  • University of Washington
  • Medstar Health Research Institute
  • Washington University School of Medicine
  • Creighton University Medical Center
  • The Methodist Hospital Research Institute
  • University of Rochester
  • University of Virginia
  • St. Paul's Hospital
  • St. Joseph, Florida
  • Cleveland Clinic Florida
  • University of Colorado, Denver
  • University of Michigan
Investigators  ICMJE
Principal Investigator: Julio Garcia Aguilar, MD, PhD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP