Clinical trial · Interventional
Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With Stage IB, Stage II, or Stage IIIB Cervical Cancer
Phase II Randomized Assessing Pelvic Irradiation Combined With Cisplatin Alone or Cisplatin Plus Cetuximab in Patients With Carcinoma of the Cervix Stage IB2, II and III
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I
- description
- Patients receive cisplatin IV over 1 hour once weekly during weeks 1-6. Patients also undergo pelvic radiotherapy 5 days a week during weeks 2-5 or 2-6.
- interventionNames
- Drug: cisplatin
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive cisplatin and undergo radiotherapy as in arm I. Patients also receive cetuximab IV over 1 hour once weekly during weeks 1-6.
- interventionNames
- Biological: cetuximab
- Drug: cisplatin
Primary outcomes (1)
- measure
- Recurrence-free survival at 2 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTde la Rochefordiere A, Kamal M, Floquet A, Thomas L, Petrow P, Petit T, Pop M, Fabbro M, Kerr C, Joly F, Sevin E, Maillard S, Cure H, Weber B, Brunaud C, Minsat M, Gonzague L, Berton-Rigaud D, Aumont M, Gladieff L, Peignaux K, Bernard V, Leroy Q, Bieche I, Margogne A, Nadan A, Fourchotte V, Diallo A, Asselain B, Plancher C, Armanet S, Beuzeboc P, Scholl SM. PIK3CA Pathway Mutations Predictive of Poor Response Following Standard Radiochemotherapy +/- Cetuximab in Cervical Cancer Patients. Clin Cancer Res. 2015 Jun 1;21(11):2530-7. doi: 10.1158/1078-0432.CCR-14-2368. Epub 2015 Feb 27. PMID 25724520