A phase ll study of adjuvant chemotherapy with Irinotecan (CPT-11) plus Nedaplatin (NDP) for stage lb2 or lla node-positive cervical cancer

Phase 2

• Conditions: Stage lb2 lla cervical cancer with pelvic lymph node metastasis

• Registration Number: JPRN-UMIN000003036
• Lead Sponsor: Japanese Gynecologic Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-14
• Study Completion: 2016-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 63

Inclusion Criteria

Not provided

Exclusion Criteria

1)Patients with paraaortic lymph node metastasis 2)Patients with positive histological margin 3)Patients with adnexal involvement 4)Patients with tumor extension to other organs 5) Patients with active infections 6) Patients with serious complications 7) Patients with active concomitant malignancy 8) Patients with interstitial pneumonia or pulmonary fibrosis 9) Patients with massive pleural, cardiac effusion, and/or ascites 10) Patients with coneraindication to CPT-11or NDP 11) Patients with diarrhea (watery stool) 12) Patients with intestinal paralysis or illeus 13) Patients with any history of serious drug reactions or hypersensitivity 14) Patients with HBs antigen 15)Patients who 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
Two-year relapse-free survival rate

Secondary Outcome Measures

Name	Time	Method
Incidence of morbidity Completeness of chemothrapy Overall survival in 5 years Relapse-free survival in 5 years Incidence of leg lymphedema