Status:
TERMINATED
Radiation Therapy, Cisplatin, Fluorouracil, and Cetuximab in Treating Patients With Locally Advanced Anal Cancer
Lead Sponsor:
UNICANCER
Conditions:
Anal Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, eith...
Detailed Description
OBJECTIVES: Primary * Evaluate the objective response (complete and partial) 8 weeks after completion of study treatment comprising radiotherapy, chemotherapy (fluorouracil and cisplatin), and cetux...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed anal cancer
- Squamous cell disease
- Locally advanced, non-metastatic disease
- One of the following clinical TNM stages:
- T2, N0, M0 (largest diameter ≥ 3 cm)
- T3-T4, N0, M0
- Any T, N1-N3, M0
- No undifferentiated small cell carcinoma or adenocarcinoma
- Measurable disease according to RECIST criteria
- Undergone endorectal ultrasound or MRI to evaluate the primary tumor
- Undergone thoraco-abdomino-pelvic scan to evaluate tumor extension
- Disease suitable to receive radiotherapy and chemotherapy
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Leukocytes ≥ 4,000/mm\^3
- ANC ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 10 g/dL
- Creatinine clearance \> 60 mL/min
- ALT and AST ≤ 5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN
- Total bilirubin ≤ 1.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- No history of cancer within the past 8 years except for in situ cervical cancer or previously treated basal cell carcinoma of the skin
- No contraindications to any component of study therapy
- No serious uncontrolled illness
- No symptomatic grade 1 angina pectoris or angina pectoris ≥ grade 2
- No congestive heart failure
- No peripheral sensory neuropathy
- No uncontrolled diabetes
- No HIV positivity
- No geographical, social, or psychological situations that preclude medical follow up
- Affiliated with a social security system
- No patient deprived of liberty or under trusteeship
- PRIOR CONCURRENT THERAPY:
- Patients with a diverting colostomy are eligible
- No prior excision of this tumor
- No prior chemotherapy or radiotherapy for the treatment of this cancer or any other history of radiotherapy or pelvic brachytherapy
- No concurrent coumarin anticoagulants, phenytoin, sorivudine or brivudine, antacids, or allopurinol
- Not registered in another clinical trial with an experimental drug
Exclusion
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 26 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00955240
Start Date
March 1 2009
End Date
November 26 2010
Last Update
February 11 2020
Active Locations (20)
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1
Institut Bergonie
Bordeaux, France, 33076
2
CHU Hopital A. Morvan
Brest, France, 29609
3
Centre Regional Francois Baclesse
Caen, France, 14076
4
Centre Hospitalier Departemental
La Roche-sur-Yon, France, F-85025