Phase I study of combination chemotherapy with irinotecan hydrochroride(CPT-11) and nedaplatin(NDP) for locally advanced stage Ib2-IVa cervical cancer after Concurrent chemoradiotherapy (CCRT)
- Conditions
- Stage Ib2-IVa cervical cancer
- Registration Number
- JPRN-UMIN000007458
- Lead Sponsor
- Japanese Gynecologic Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 48
Not provided
1) Patients with serious complications 2) Patients with active infections 3) Patients with active concomitant malignancy 4) Patients underwent exploratory laparotomy 5) Patients with interstitial pneumonia or pulmonary fibrosis 6) Patients with massive pleural, cardiac effusion, and/or ascites 7) Patients with coneraindication to CPT-11or NDP 8) Patients with diarrhea (watery stool) 9) Patients with any history of serious drug reactions or hypersensitivity 10) Patients with HBs antigen 11) Patients treated with radiation therapy of the paraaortic lymph nodes in cervical carcinoma 12) Patients with progression of cervical carcinoma disease during concurrent chemoradiotherapy(CCRT) 13)Patients are inappropriate to enter this study with any safety reasons, judged by the treating physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recommended Dose(RD)
- Secondary Outcome Measures
Name Time Method 1)Incidence of morbidity 2)Completeness