Phase III study of Z-100 in uterine cervix cancer patients

Authors
Category Primary study
JournalUMIN Clinical Trials Registry
Year 2005
INTERVENTION: Z group : During radiotherapy period, Z‐100 subcutaneous administration into upper arm (1 ampul, 2 times/week, 3‐4 day interval, start within 3 days after radiotherapy). Only response case, after judgement of tumor size reduction, Z‐100 subcutaneous administration into upper arm (1 ampul, 1 times/2 week, start within 21 days after judgement of tumor size reduction) P group : During radiotherapy period, placebo subcutaneous administration into upper arm (1 ampul, 2 times/week, 3‐4 day interval, start within 3 days after radiotherapy). Only response case, after judgement of tumor size reduction, placebo subcutaneous administration into upper arm (1 ampul, 1 times/2 week, start within 21 days after judgement of tumor size reduction) CONDITION: primary uterine cervix cancer PRIMARY OUTCOME: Overall Survival SECONDARY OUTCOME: Cancer Death‐Free Survival; Relapse‐Free Survival; Effect of tumor size reduction; Adverse Drug Reaction, Adverse Events INCLUSION CRITERIA: 1)FIGO stage II‐IVa 2)Histologically proven epidermoid carcinoma 3)No prior treatment for uterine cervix cancer 4)No abdominal paraaortic lymph node metastases 5)Being able to have intravaginal radiation therapy 6)Performance Status(PS) 0,1,2 7)Sufficient organ function (bone marrow, liver, kidney) 8)Written Informed Consent
Epistemonikos ID: 9e0b8884470eefffd0064ad7114ef17b06273301
First added on: Aug 21, 2024