Open-label, multicenter study to evaluate the safety and efficacy of oral etoposide and iv cisplatin for patients with advanced or recurrent cervical cancer
Not Applicable
- Conditions
- Cervical cancer
- Registration Number
- JPRN-jRCT2080221037
- Lead Sponsor
- ippon Kayaku Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Female
- Target Recruitment
- 40
Inclusion Criteria
1) Histologically or cytologically or clinically confirmed cervical cancer
2) Measurable lesion
3) Previously untreated Stage IIIB/IV not amenable to curative surgery or radiation therapy, recurrent or persistent disease
4) ECOG PS 0-2
5) Body Weight >= 35 kg
6) Survival period more than 3 months
7) Normal organ function
(WBC >= 3,000/mm3, platelets >= 100,000/mm3, hemoglobin >= 9.0g/dL, AST/ALT =< 2 x ULN (patients with liver metastases doesn't have the limitation), total bilirubin =< ULN, serum creatinine =< ULN)
8) Written informed consent
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method