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)
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
overall survival
During the study conduct
No
Toshiharu Kamura, MD, PhD
Study Chair
Kurume University School of Medicine
Japan: Ministry of Health, Labor and Welfare
JCOG0505
NCT00295789
February 2006
November 2011
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