JPRN-UMIN000008023
Recruiting
Phase 2
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 - NACRAC study
The Obstetrical and Gynecological Society of Kinki District Japan and the Kansai Clinical Oncology Group0 sites68 target enrollmentMay 28, 2012
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- The Obstetrical and Gynecological Society of Kinki District Japan and the Kansai Clinical Oncology Group
- Enrollment
- 68
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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