Return to List

Study Summary
No. RTOG R0012:.............Christopher H. Crane......Radiation Oncology
.
Study Summary Title
Study Summary
Number:		RTOG R0012
Study Title:RANDOMIZED PHASE II TRIAL OF PREOPERATIVE COMBINED MODALITY CHEMORADIATION FOR DISTAL RECTAL CANCER
.
Physician New Patient Referral
Name:Christopher H. CranePatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Radiation OncologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-0782
Contact us about clinical trials
.
General Information
Disease Group:Supported By:N/A
Phase of Study:Phase IIReturn
Visit:		Patients will have follow-up blood work and procto/sigmoidoscopy every 3
months after treatment. They will have repeat CT abdo/pelvis every 6 months.
Treatment
Agents:		Home Care:None
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:		Hospitalization is not planned for administration of therapy. Short periods of
hospitalization (1-3 days) may be required for supportive care.
Description/
Intervention:		The goal of this clinical research study is to find out if giving higher than
standard doses of radiotherapy with the drug 5-fluorouracil (5-FU), with or
without the drug CPT-11, will shrink rectal tumors before they are removed in
patients with distal rectal cancer. Researchers will compare the two
treatments to learn which is more effective. The safety of the treatment will
also be studied.
.
Study Objectives / Outcomes
1. To evaluate the pathologic complete response rates of two novel chemoradiation regimens.
2. Secondary endpoints include acute and late normal tissue toxicity, pattern of failure and complete resection.
.
Study Status Information
Study Activation / Registration Date:07/16/2001
IRB Review and Approval Date:06/06/2001
Study Type:Therapeutic
Recruitment Status:Terminated
Projected Accrual:10
.
Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:Unavailable
Exclusion Criteria:Unavailable
.
Links
Registration Number: NCT00006366
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
.
Results

Return to Clinical Trials at M.D. Anderson Cancer Center