Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer

Completed · Phase 2

Conditions studied: Colorectal Cancer

In brief

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. Chemoradiotherapy (combining chemotherapy with radiation therapy) before surgery may shrink the tumor so that it can be removed. Giving chemotherapy after surgery may kill any remaining tumor cells. PURPOSE: This randomized phase II trial is studying two different regimens of neoadjuvant chemoradiotherapy and adjuvant chemotherapy and comparing how well they work in treating patients who are undergoing surgical resection for locally advanced rectal cancer.

Key facts

Study ID

NCT00081289

Run by

Radiation Therapy Oncology Group

People needed

146

Starts

2004-03-01

Expected to finish

2016-12-01

Last updated by the study team

2020-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of California Davis Cancer Center — Sacramento, California, United States
• Baptist-South Miami Regional Cancer Program — Miami, Florida, United States
• Ingalls Cancer Care Center at Ingalls Memorial Hospital — Harvey, Illinois, United States
• Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton — Marlton, New Jersey, United States
• Northeast Radiation Oncology Center — Dunmore, Pennsylvania, United States

Full record on ClinicalTrials.gov

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