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



Status:Recruiting
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/5/2019
Start Date:November 2013
End Date:November 2019
Contact:Julio Garcia Aguilar, MD PhD
Phone:212-639-5117

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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).


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.
We found this trial at
26
sites
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Peter O'Donnell, MD
Phone: 888-824-0200
University of Chicago One of the world's premier academic and research institutions, the University of...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Luca Stocchi, MD
Phone: 216-445-7882
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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9850 Nicholas St # 100
Omaha, Nebraska 68114
Phone: 402-343-1122
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Phone: 503-494-4373
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Principal Investigator: Mohammed Tejani, MD
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
Principal Investigator: Jorge Marcet, MD
Phone: 813-259-0925
University of South Florida The University of South Florida is a high-impact, global research university...
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2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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Aurora, Colorado 80045
Phone: 720-848-0150
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Basking Ridge, New Jersey 07920
Phone: 212-639-5117
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Burlington, Vermont 05405
Phone: 802-847-1288
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Charles Friel, MD
Phone: 434-243-9970
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Commack, New York 11725
Phone: 212-639-5117
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500 Westchester Avenue
Harrison, New York 10604
Phone: 212-639-5117
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Irvine, California 92697
949-824-5011
Phone: 888-717-4463
University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
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225 Summit Avenue
Montvale, New Jersey 07645
Phone: 212-639-5117
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Julio Garcia-Aguilar, MD, PhD
Phone: 212-639-5117
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Northville, Michigan 48168
Phone: 248-305-4400
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Omaha, Nebraska 68114
Phone: 402-343-1122
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Orange, California 92868
Principal Investigator: Anita Gregory, MD
Phone: 714-835-8300
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1000 N Village Ave
Rockville Centre, New York 11570
(516) 256-3600
Phone: 212-639-5117
Memorial Sloan-Kettering at Mercy Medical Center Memorial Sloan Kettering Cancer Center Rockville Centre provides state-of-the-art...
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Steven Hunt, MD
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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San Francisco, California 94143
Phone: 415-885-3606
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Seattle, Washington 98195
Principal Investigator: Andrew Coveler, MD
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Sleepy Hollow, New York
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Walnut Creek, California 94598
Principal Investigator: Samuel Oommen, MD
Phone: 925-274-9000
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110 Irving St NW
Washington, District of Columbia 20010
(202) 877-7000
Principal Investigator: Jennifer Ayscue, MD
Phone: 202-877-8484
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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