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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborators:
Colon and Rectal Surgery Inc.
The Cleveland Clinic
John Muir Health
Oregon Health and Science University
St. Joseph Hospital Health Center
University of Calgary
University of California, Irvine
University of California, San Francisco
University of Chicago
University of South Florida
University of Vermont
University of Washington
Washington Hospital Center
Washington University Early Recognition Center
Bergan Mercy Medical Centere
The Methodist Hospital System
University of Rochester
University of Virginia
St. Paul's Hospital
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT02008656
First received: November 27, 2013
Last updated: September 19, 2014
Last verified: July 2014

November 27, 2013
September 19, 2014
November 2013
November 2017   (final data collection date for primary outcome measure)
disease-free survival (DFS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT02008656 on ClinicalTrials.gov Archive Site
major adverse events [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Same as current
Not Provided
Not Provided
 
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
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

The study is designed to test the hypothesis that patients with distal 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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Rectal Cancer
  • 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: 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 6 cycles of CapeOX over a period of approximately 16-18 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
222
Not Provided
November 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed diagnosis of adenocarcinoma of the rectum Confirmation will be done at MSKCC or locally for participating sites.
  • Clinical Stage II (T3-4, N-) or Stage III (any T, N+) based on MRI
  • Distal tumor margin at ≤ 6 cm from the anal verge or patients who require an APR or CAA according to treating physician
  • No evidence of distant metastases
  • No prior pelvic radiation therapy
  • No prior chemotherapy or surgery for rectal cancer
  • Age > or = 18 years
  • No infections requiring systemic antibiotic treatment
  • 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, 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.
  • Serum 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.
Both
18 Years and older
No
Contact: Julio Garcia Aguilar, MD PhD 212-639-5117
Contact: Leonard Saltz, MD 646-888-4181
United States
 
NCT02008656
13-213
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
  • Colon and Rectal Surgery Inc.
  • The Cleveland Clinic
  • John Muir Health
  • Oregon Health and Science University
  • St. Joseph Hospital Health Center
  • University of Calgary
  • University of California, Irvine
  • University of California, San Francisco
  • University of Chicago
  • University of South Florida
  • University of Vermont
  • University of Washington
  • Washington Hospital Center
  • Washington University Early Recognition Center
  • Bergan Mercy Medical Centere
  • The Methodist Hospital System
  • University of Rochester
  • University of Virginia
  • St. Paul's Hospital
Principal Investigator: Julio Garcia Aguilar, MD, PhD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
July 2014

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