Status:
COMPLETED
Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer
Lead Sponsor:
Radiation Therapy Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Chemoradiot...
Detailed Description
OBJECTIVES: * Evaluate the pathologic complete response rate in patients with locally advanced rectal cancer undergoing surgical resection treated with 2 different regimens of neoadjuvant chemoradiot...
Eligibility Criteria
Inclusion
- Adenocarcinoma of the rectum originating at or below 12 cm from the anal verge without evidence of distant metastases
- Patient must be 18 years of age or greater.
- Potentially resectable en bloc based upon surgeon evaluation
- Clinical stages T3 or T4, based upon endorectal ultrasound, or physical examination (only acceptable for T4 lesions).
- Absolute neutrophil count of \> 1500 per microliter and platelet count \> 100,000 per microliter; aspartate aminotransferase (AST) and alkaline phosphatase \< 2.5 X upper limit of normal (ULN), bilirubin \< = 1.5 ULN, calculated creatinine clearance \> 50 ml/min using Cockcroft-Gault formula:
- CrCl male = (140 - age) x (wt. in kg) / (Serum Cr) x 72
- CrCl female = 0.85 x (CrCl male)
- Zubrod performance status 0-2
- No history of other malignancies within 5 years, except non-melanoma skin cancer, in situ carcinoma of the cervix, or ductal carcinoma in situ of the breast. Previous invasive cancer permitted if disease free at least 5 years.
- Signed study-specific informed consent prior to randomization
Exclusion
- Any evidence of distant metastasis
- Synchronous primary colon carcinomas, except T1 lesions (full colonoscopy not required for enrollment)
- Extension of malignant disease to the anal canal
- Prior radiation therapy to the pelvis
- Prior chemotherapy for malignancies
- Pregnancy or lactation, (exclusion due to potential adverse effects of therapy). Women of childbearing potential with either a positive or no pregnancy test (serum or urine) at baseline. Women/men of childbearing potential not using a reliable and appropriate contraceptive method. (Postmenopausal women must have been amenorrheic for at least 12 months to be considered to be of non-childbearing potential.) Patients will agree to continue contraception for 30 days from the date of the last study drug administration.
- Serious, uncontrolled, concurrent infection(s).
- Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
- Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.
- Evidence of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake.
- Other serious uncontrolled medical conditions that the investigator feels might compromise study participation.
- Major surgery within 4 weeks of the study treatment.
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
- Known, existing uncontrolled coagulopathy.
- No concurrent cimetidine allowed.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT00081289
Start Date
March 1 2004
End Date
December 1 2016
Last Update
February 27 2020
Active Locations (5)
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1
University of California Davis Cancer Center
Sacramento, California, United States, 95817
2
Baptist-South Miami Regional Cancer Program
Miami, Florida, United States, 33176
3
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
4
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States, 08053