Status:
UNKNOWN
Radiation Therapy, Irinotecan, and Cetuximab in Treating Patients Who Are Undergoing Surgery for Stage III or Stage IV Rectal Cancer
Lead Sponsor:
Centre Hospitalier Universitaire Vaudois
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-74 years
Phase:
PHASE1
Brief Summary
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such...
Detailed Description
OBJECTIVES: Primary * Determine the toxicity of irinotecan hydrochloride and cetuximab in patients with stage III or IV rectal cancer undergoing conformal or intensity-modulated radiotherapy. Secon...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the rectum
- T3-4 and/or N+ (stage IIIB, IIIC, or IV disease)
- Liver or lung metastasis allowed
- No recurrent disease
- PATIENT CHARACTERISTICS:
- WHO performance status 0 or 1
- Hematologic, liver, and renal function normal
- Considered fit for chemotherapy, radiotherapy, and surgery
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- No symptomatic heart disease or myocardial infarction during the past 6 months
- No chronic inflammatory bowel disease
- No malignant tumor during the past 5 years except for completely surgically resected carcinoma of the cervix or squamous cell carcinoma of the skin
- No other concurrent malignant tumor
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy for rectal cancer
- No prior radiotherapy to the pelvis
Exclusion
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00392470
Start Date
August 1 2006
Last Update
May 25 2011
Active Locations (3)
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1
Kantonsspital Aarau
Aarau, Switzerland, CH-5000
2
Institut Ludwig de Recherche sur le Cancer
Épalinges, Switzerland, 1066
3
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011