drugset / Trial / NCT01999933

Evaluation of Postoperative Radiotherapy and Concurrent Chemotherapy Effectiveness in Cervical Cancer

NCT01999933

Phase 2/3 Unknown 600 enrolled Mei Shi
RandomizedParallel-groupOpen-labelTreatment

Summary

The present study is a randomized, control, phase II/III study of early stage (FIGO Ia2-IIb) cervical cancer after radical hysterectomy in Northwest China treated with radiotherapy or concurrent chemoradiotherapy based on the surgical-pathological risk factors. All the patients received whole pelvis radiation and were divided into three groups according to adjuvant chemotherapy: concurrent chemotherapy with cisplatin weekly (40mg/m2) , concurrent chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2), or concurrent and adjuvant chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2). The effectiveness, and side effects will be evaluated according to Standard WHO response criteria, and NCI common toxicity criteria for adverse events(NCI-CTC-AE) V3.0.

Timeline

Start
2013-11
Primary completion
2016-11
Completion
2018-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cisplatin Other / unclassified 40 mg/m2
Comparator Cisplatin Other / unclassified 75 mg/m2
Subject Docetaxel Small molecule 75 mg/m2