Status:
COMPLETED
Intensity-Modulated Radiation Therapy With Incorporated Boost and Capecitabine Before Surgery in Treating Patients With Locally Advanced Rectal Cancer
Lead Sponsor:
Fox Chase Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Intensity-modulated radiation therapy (radiation directed at the tumor more precisely than in standard radiation therapy) wi...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose of neoadjuvant boost intensity-modulated radiotherapy when combined with capecitabine before surgery in patients with locally advanced rect...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed primary adenocarcinoma of the rectum
- Distal border of the tumor within 12 cm of the anal verge by proctoscopic exam
- Clinical stage T3-4, N1-2 (stage II or III) disease by 2 of the following tests:
- Physical exam
- Transrectal ultrasound
- Pelvic CT scan
- Pelvic MRI
- No clinical evidence of metastatic disease
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-1
- Life expectancy
- More than 3 months
- Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- No known, uncontrolled coagulopathy
- Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- SGOT and SGPT ≤ 1.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- Renal
- Creatinine ≤ 1.5 times normal
- Creatinine clearance \> 50 mL/min
- Cardiovascular
- No clinically significant cardiac disease
- No congestive heart failure
- No symptomatic coronary artery disease
- No poorly controlled cardiac arrhythmias
- No myocardial infarction within the past year
- Gastrointestinal
- No active inflammatory bowel disease
- No lack of physical integrity of the upper gastrointestinal tract
- No malabsorption syndrome
- Other
- No other prior or concurrent malignancy except inactive, non-invasive carcinoma of the cervix or non-melanoma skin cancer
- No concurrent serious, uncontrolled infection(s)
- No prior unanticipated severe reaction to fluoropyrimidine therapy
- No known sensitivity to fluorouracil
- No prior uncontrolled seizures
- No CNS disorders that would preclude study participation
- No other medical or psychiatric condition that would preclude study participation
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study participation
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No prior immunotherapy for rectal cancer
- Chemotherapy
- No prior chemotherapy for rectal cancer
- Endocrine therapy
- Not specified
- Radiotherapy
- No prior radiotherapy for rectal cancer
- No prior pelvic radiotherapy
- Surgery
- More than 4 weeks since prior major surgery and recovered
- No prior surgery for rectal cancer
- Other
- More than 4 weeks since prior participation in another investigational drug study
- No concurrent celecoxib
Exclusion
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
End Date :
February 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00084591
Start Date
December 1 2003
End Date
February 1 2007
Last Update
February 12 2010
Active Locations (1)
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1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497