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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Memorial Sloan Kettering Cancer Center
With
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
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | 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
