Status:
UNKNOWN
Concurrent Chemo-Radiotherapy Versus Radiotherapy With Boost in Locally Advanced Unresectable Rectal Cancers
Lead Sponsor:
Tata Memorial Hospital
Conditions:
Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
At Tata Memorial Hospital 50% of the patients present in the locally advanced stage which is technically unresectable, or that is beyond the realm of a potentially curative surgical resection. The eva...
Detailed Description
Aims/ Objectives 1. To compare the resectability rate when patients are treated when conventional chemoradiation to patients treated with radiation alone with an additional boost to the primary tumor...
Eligibility Criteria
Inclusion
- Patients with measurable disease, medically able to undergo pelvic surgery.
- Patients with unresectable adenocarcinoma of the rectum located up to 12 cm from the anal verge without evidence of distant metastases.
- Patients must be 18 years old or greater.
- Patients with clinical stage T3 orT4 based on endorectal ultrasound or physical exam.
- Patients with lab values within standard protocol parameters
- Karnofsky performance status \> 60.
- No history of other malignancies within 5 years, except non-melanoma skin cancer, in situ carcinoma of the cervix or ductal carcinoma of the breast. Previous invasive cancer permitted if disease-free at least 5 years
- Patient must sign study-specific consent prior to randomization.
Exclusion
- Any evidence of distant metastasis
- Synchronous primary colon carcinomas, except T1 lesions
- Prior radiation therapy to the pelvis
- Prior chemotherapy for malignancies
- Pregnancy or lactation.
- Serious, uncontrolled, concurrent infection(s).
- 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 mal-absorption syndrome.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00808379
Start Date
May 1 2006
End Date
July 1 2009
Last Update
December 15 2008
Active Locations (1)
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1
Tata Memorial Centre
Mumbai, Maharashtra, India, 400012