CompletedPhase 2

Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With Stage IB, Stage II, or Stage IIIB Cervical Cancer

France76 participantsStarted 2009-03

Plain-language 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 cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether radiation therapy given together with cisplatin is more effective with or without cetuximab in treating patients with cervical cancer. PURPOSE: This randomized phase II trial is studying giving radiation therapy together with cisplatin to see how well it works compared with radiation therapy and cisplatin given together with cetuximab in treating patients with stage IB, stage II, or stage IIIB cervical cancer.

Who can participate

Age range18 Years – 120 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 th…

What they're measuring

Recurrence-free survival at 2 years

Trial details

NCT IDNCT00957411

SponsorInstitut Curie

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-11