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

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.

Timeline

Start

2009-03

Primary completion

2013-11

Completion

2014-10

Outcome

Missed primary endpoint

paper Cetuximab over a 6-week period did not improve DFS at 24 months. PMID 25724520 ↗

Publications

• Results de 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.

Drugs

Indications