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
NCT ID: NCT02008656
Last Updated: 2025-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
358 participants
INTERVENTIONAL
2013-11-30
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Oxaliplatin (OXAL)
5-Fluorouracil (5-FU)
Leucovorin
Capecitabine (Xeloda®)
intensity modulated radiotherapy (IMRT)
Quality of Life Questionnaires
DRE-Endoscopy
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.
Oxaliplatin (OXAL)
5-Fluorouracil (5-FU)
Leucovorin
Capecitabine (Xeloda®)
intensity modulated radiotherapy (IMRT)
Quality of Life Questionnaires
DRE-Endoscopy
Interventions
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Oxaliplatin (OXAL)
5-Fluorouracil (5-FU)
Leucovorin
Capecitabine (Xeloda®)
intensity modulated radiotherapy (IMRT)
Quality of Life Questionnaires
DRE-Endoscopy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Colon and Rectal Surgery Inc.
INDUSTRY
The Cleveland Clinic
OTHER
John Muir Health
OTHER
Oregon Health and Science University
OTHER
St. Joseph Hospital of Orange
OTHER
University of California, Irvine
OTHER
University of California, San Francisco
OTHER
University of Chicago
OTHER
University of South Florida
OTHER
University of Vermont
OTHER
University of Washington
OTHER
Medstar Health Research Institute
OTHER
Washington University School of Medicine
OTHER
Creighton University Medical Center
OTHER
The Methodist Hospital Research Institute
OTHER
University of Rochester
OTHER
University of Virginia
OTHER
St. Paul's Hospital
UNKNOWN
St. Joseph, Florida
UNKNOWN
Cleveland Clinic Florida
OTHER
University of Colorado, Denver
OTHER
University of Michigan
OTHER
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Julio Garcia Aguilar, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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University of California, Irvine
Irvine, California, United States
St. Joseph Hospital
Orange, California, United States
University of California San Francisco
San Francisco, California, United States
John Muir Health
Walnut Creek, California, United States
University of Colorado
Aurora, Colorado, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
University Of South Florida
Tampa, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
University of Chicago
Chicago, Illinois, United States
University of Michigan
Northville, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
CHI Heath Bergan Mercy
Omaha, Nebraska, United States
Colon and Rectal Surgery, Incorporated
Omaha, Nebraska, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States
Memorial Sloan Kettering Commack
Commack, New York, United States
Memorial Sloan Kettering Westchester
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Memorial Sloan Kettering Cancer Center at Phelps
Sleepy Hollow, New York, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Vermont Medical Center
Burlington, Vermont, United States
University of Virginia
Charlottesville, Virginia, United States
University of Washington School of Medicine
Seattle, Washington, United States
Countries
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References
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Williams H, Omer DM, Thompson HM, Lin ST, Verheij FS, Miranda J, Yuval JB, Buckley J, Marco MR, Qin LX, Dombroski DA, Kedar R, Oto A, Korngold E, Veniero JC, Gandhi S, Krishnaraj A, Jagtiani M, Ohanian K, Vu D, Hope TA, Lee S, Wasnik AP, Madhuripan N, Gollub MJ, Garcia-Aguilar J; OPRA Consortium. MRI Predicts Residual Disease and Outcomes in Watch-and-Wait Patients with Rectal Cancer. Radiology. 2024 Sep;312(3):e232748. doi: 10.1148/radiol.232748.
Thompson HM, Omer DM, Lin S, Kim JK, Yuval JB, Verheij FS, Qin LX, Gollub MJ, Wu AJ, Lee M, Patil S, Hezel AF, Marcet JE, Cataldo PA, Polite BN, Herzig DO, Liska D, Oommen S, Friel CM, Ternent CA, Coveler AL, Hunt SR, Garcia-Aguilar J; OPRA Consortium. Organ Preservation and Survival by Clinical Response Grade in Patients With Rectal Cancer Treated With Total Neoadjuvant Therapy: A Secondary Analysis of the OPRA Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2350903. doi: 10.1001/jamanetworkopen.2023.50903.
Verheij FS, Omer DM, Williams H, Lin ST, Qin LX, Buckley JT, Thompson HM, Yuval JB, Kim JK, 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, Guillem JG, Temple L, Goodman KA, Segal NH, Cercek A, Yaeger R, Nash GM, Widmar M, Wei IH, Pappou EP, Weiser MR, Paty PB, Smith JJ, Wu AJ, Gollub MJ, Saltz LB, Garcia-Aguilar J. Long-Term Results of Organ Preservation in Patients With Rectal Adenocarcinoma Treated With Total Neoadjuvant Therapy: The Randomized Phase II OPRA Trial. J Clin Oncol. 2024 Feb 10;42(5):500-506. doi: 10.1200/JCO.23.01208. Epub 2023 Oct 26.
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.
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.
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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13-213
Identifier Type: -
Identifier Source: org_study_id
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