Phase II multicenter trial of neoadjuvant chemotherapy followed by radical hysterectomy and adjuvant chemotherapy by irrinotecan hydrochloride and nedaplatin for the patients with stage Ib2-IIb bulky cervical cancer (tumor diameter > 4 cm): OGSK_KCOG-G1201
- Conditions
- Cervical cancer
- Registration Number
- JPRN-UMIN000008023
- Lead Sponsor
- The Obstetrical and Gynecological Society of Kinki District Japan and the Kansai Clinical Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 68
Not provided
1. Patients with an active or uncontrolled infection, 2. Patients with a serious complications (cardiac disease, poorly controlled diabetes mellitus, malignant hypertension and bleeding tendency), 3. Patients with other malignancies, 4. Patients with interstitial pneumonitis, 5. Patients with massive pleural effusion and/or ascites, 6. Patients with unstable angina or those who have had a myocardial infarction within the past six months, 7. Patients with medical contraindications to irrinotecan hydrochloride and nedaplatin, 8. Patients with severe diarrhea, 9. Patients with bowel obstruction, 10. Patients who are pregnant or lactating, 11. Patients with severe drug allergy, 12. Patients whose circumstances at the time of entry onto the protocol would not permit completion of study required follow-up, 13. Patients with HBsAg positivity
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method