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

Phase 3 Completed 253 enrolled Haruhiko Fukuda Ministry of Health, Labour and Welfare, Japan · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

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

Timeline

Start: 2006-02
Primary completion: 2011-11
Completion: 2011-11

Outcome

Met primary endpoint

paper The HR of OS was 0.994 (90% CI, 0.79 to 1.25; noninferiority P = .032 by stratified Cox regression). PMID 25732161 ↗

paper CONCLUSION: TC was noninferior to TP and should be a standard treatment option for metastatic or recurrent cervical cancer. PMID 25732161 ↗

Publications

Kitagawa R, Katsumata N, Shibata T, Kamura T, Kasamatsu T, Nakanishi T, Nishimura S, Ushijima K, Takano M, Satoh T, Yoshikawa H. Paclitaxel Plus Carboplatin Versus Paclitaxel Plus Cisplatin in Metastatic or Recurrent Cervical Cancer: The Open-Label Randomized Phase III Trial JCOG0505. J Clin Oncol. 2015 Jul 1;33(19):2129-35. doi: 10.1200/JCO.2014.58.4391. Epub 2015 Mar 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carboplatin	Small molecule	5 unknown	—
Comparator	Cisplatin	Other / unclassified	50 mg/m2	—
Comparator	Paclitaxel	Small molecule	135 mg/m2	—
Comparator	Paclitaxel	Small molecule	175 mg/m2	—