Trial of TP Versus TC Regimens for Stage IVb, Persistent, or Recurrent Cervical Cancer (JCOG0505, CC-TPTC-P3)

Uterine Cervical Neoplasms Clinical Trial

Official title: A Randomized Phase III Trial of Paclitaxel Plus Cisplatin Versus Paclitaxel Plus Carboplatin in Stage IVb, Persistent, or Recurrent Cervical Cancer (JCOG0505, CC-TPTC-P3)

Status Completed

Clinical Trial Summary

To evaluate the clinical benefits of Paclitaxel plus Carboplatin compared with Paclitaxel plus Cisplatin in Stage IVb, Persistent, or Recurrent Cervical Cancer

Clinical Trial Description

Prognosis of the advanced, recurrent, or persistent cervical cancer, which is not amenable to curative treatment with surgery and/or radiation therapy, still remains poor. Recently, cisplatin plus paclitaxel for palliative chemotherapy were reported to improve the response rate and progression-free interval compared to cisplatin alone and has been shown as a new appropriate regimen. However, more effective and/or less toxic combinations are needed. Carboplatin as a single agent has less response rate but less overall toxicity than cisplatin. Particularly, because less nephrotoxicity does not require hydration and less neurotoxicity enables 3hrs administration of paclitaxel in the combination, out patient therapy becomes possible and patients' quality of life must improve. Therefore, we planned to evaluate the benefits of less toxicity of the chemotherapy containing paclitaxel and carboplatin, which could reduce the hospitalised days, in comparison with the standard chemotherapy containing paclitaxel and cisplatin. This clinical trial is targeted on the patients in Japan with incurable cervical cancer diagnosed by means of image. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Uterine Cervical Neoplasms

• NCT number: NCT00295789
• Study type: Interventional
• Source: Japan Clinical Oncology Group
• Status: Completed
• Phase: Phase 3
• Start date: February 2006
• Completion date: November 2011