Status:
COMPLETED
Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With Stage IB, Stage II, or Stage IIIB Cervical Cancer
Lead Sponsor:
Institut Curie
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the...
Detailed Description
OBJECTIVES: Primary * Evaluate the efficacy of treatment with cetuximab and a standard radiochemotherapy regimen (pelvic radiotherapy and cisplatin) in patients with stage IB2, II, and IIIB cervical...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of cervical cancer
- Squamous cell carcinoma or adenocarcinoma
- Stage IB2-IIIB disease
- Not immediately operable
- Origin of the tumor and presence of measurable target lesion according to RECIST criteria confirmed by T2-weighted MRI
- Data imaging scan and PET scan (optional) confirmed absence of lumbo-aortic adenopathy
- No other associated pathology that would preclude study treatment
- PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- Hemoglobin \> 10 g/dL
- ANC \> 1,500/mm\^3
- Platelet count \> 100,000/mm\^3
- Alkaline phosphatase \< 2 times normal
- Total bilirubin \< 1.5 times normal
- Creatinine \< 130 μmol/L
- Creatinine clearance ≥ 60 mL/min
- Normal vital functions
- Not pregnant
- Fertile patients must use effective contraception
- Able to provide the imaging exams on CD ROM (DICOM 3.0 or higher) for centralized review
- No history of another cancer that recurred within the past 5 years except for basal cell carcinoma of the skin or carcinoma in situ of the cervix
- No absolute contraindication to MRI (i.e., claustrophobia, pacemaker, or cochlear implant)
- No geographical, social, or psychological situations that preclude study follow up
- Not deprived of liberty or under guardianship
- Receiving benefits from a social security system
- PRIOR CONCURRENT THERAPY:
- No prior treatment (i.e., chemotherapy, radiotherapy, immunotherapy, hormonal therapy, or, especially, therapy with an investigational agent) for this cancer
- No concurrent participation in a clinical trial with an experimental agent
Exclusion
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00957411
Start Date
March 1 2009
End Date
October 1 2014
Last Update
November 24 2025
Active Locations (1)
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1
Institut Curie Hopital
Paris, France, 75248