- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02008656
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
December 27, 2023 updated by: Memorial Sloan Kettering Cancer Center
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 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).
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Interventional
Enrollment (Actual)
358
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Irvine, California, United States, 92697
- University of California, Irvine
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Orange, California, United States, 92868-3849
- St. Joseph Hospital
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San Francisco, California, United States, 94143
- University of California San Francisco
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Walnut Creek, California, United States, 94598
- John Muir Health
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Washington Hospital Center
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Florida
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Tampa, Florida, United States, 33620
- University of South Florida
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Weston, Florida, United States, 33331
- Cleveland Clinic Florida
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago
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Michigan
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Northville, Michigan, United States, 48168
- University of Michigan
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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Nebraska
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Omaha, Nebraska, United States, 68114
- Colon and Rectal Surgery, Incorporated
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Omaha, Nebraska, United States, 68114
- CHI Heath Bergan Mercy
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New Jersey
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Basking Ridge, New Jersey, United States, 07920
- Memorial Sloan Kettering Basking Ridge
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Montvale, New Jersey, United States, 07645
- Memorial Sloan Kettering Bergen
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New York
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Commack, New York, United States, 11725
- Memorial Sloan Kettering Commack
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Harrison, New York, United States, 10604
- Memorial Sloan Kettering Westchester
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Rochester, New York, United States, 14642
- University of Rochester Medical Center
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Sleepy Hollow, New York, United States, 10591
- Memorial Sloan Kettering Cancer Center at Phelps
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Uniondale, New York, United States, 11553
- Memorial Sloan Kettering Nassau
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health & Science University
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Vermont
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Burlington, Vermont, United States, 05401
- University of Vermont Medical Center
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Virginia
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Charlottesville, Virginia, United States, 22908
- University of Virginia
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Washington
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Seattle, Washington, United States, 98109
- University of Washington School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
disease-free survival (DFS)
Time Frame: 3 years
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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
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3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
major adverse events
Time Frame: 3 years
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Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
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3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Julio Garcia Aguilar, MD, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Garcia-Aguilar J, Chow OS, Smith DD, Marcet JE, Cataldo PA, Varma MG, Kumar AS, Oommen S, Coutsoftides T, Hunt SR, Stamos MJ, Ternent CA, Herzig DO, Fichera A, Polite BN, Dietz DW, Patil S, Avila K; Timing of Rectal Cancer Response to Chemoradiation Consortium. Effect of adding mFOLFOX6 after neoadjuvant chemoradiation in locally advanced rectal cancer: a multicentre, phase 2 trial. Lancet Oncol. 2015 Aug;16(8):957-66. doi: 10.1016/S1470-2045(15)00004-2. Epub 2015 Jul 14.
- Garcia-Aguilar J, Patil S, Gollub MJ, Kim JK, Yuval JB, Thompson HM, Verheij FS, Omer DM, Lee M, Dunne RF, Marcet J, Cataldo P, Polite B, Herzig DO, Liska D, Oommen S, Friel CM, Ternent C, Coveler AL, Hunt S, Gregory A, Varma MG, Bello BL, Carmichael JC, Krauss J, Gleisner A, Paty PB, Weiser MR, Nash GM, Pappou E, Guillem JG, Temple L, Wei IH, Widmar M, Lin S, Segal NH, Cercek A, Yaeger R, Smith JJ, Goodman KA, Wu AJ, Saltz LB. Organ Preservation in Patients With Rectal Adenocarcinoma Treated With Total Neoadjuvant Therapy. J Clin Oncol. 2022 Aug 10;40(23):2546-2556. doi: 10.1200/JCO.22.00032. Epub 2022 Apr 28.
- Shi DD, Mamon HJ. Playing With Dynamite? A Cautious Assessment of TNT. J Clin Oncol. 2021 Jan 10;39(2):103-106. doi: 10.1200/JCO.20.02199. Epub 2020 Oct 14. No abstract available.
- Smith JJ, Chow OS, Gollub MJ, Nash GM, Temple LK, Weiser MR, Guillem JG, Paty PB, Avila K, Garcia-Aguilar J; Rectal Cancer Consortium. Organ Preservation in Rectal Adenocarcinoma: a phase II randomized controlled 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 nonoperative management. BMC Cancer. 2015 Oct 23;15:767. doi: 10.1186/s12885-015-1632-z.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2013
Primary Completion (Estimated)
November 1, 2024
Study Completion (Estimated)
November 1, 2024
Study Registration Dates
First Submitted
November 27, 2013
First Submitted That Met QC Criteria
December 6, 2013
First Posted (Estimated)
December 11, 2013
Study Record Updates
Last Update Posted (Actual)
December 28, 2023
Last Update Submitted That Met QC Criteria
December 27, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Rectal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Micronutrients
- Vitamins
- Antidotes
- Vitamin B Complex
- Fluorouracil
- Capecitabine
- Oxaliplatin
- Leucovorin
Other Study ID Numbers
- 13-213
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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