Multi-institutional phase II study of concurrent chemoradiotherapy using high-dose-rate intracavitary brachytherapy for locally advanced uterine cervical cancer.

UMIN ID: UMIN000001042

Registered date:19/02/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Locally advanced cervical cancer
• Date of first enrollment: 2008/01/01
• Target sample size: 70
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Concurrent chemoradiotherapy: CCRT Cisplatin (40mg/m2, weekly, 5 courses) Radiothrapy: BED 74-78Gy10 External beam: whole pelvis 50-50.4Gy/25-28fr (CS after 30-41.4Gy) HDR-ICBT : 6Gy x 3-4 (point A)

Outcome(s)

• Primary Outcome: Progression-free survival
• Secondary Outcome: Feasibility, Toxicity, Tumor response, Overall survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Female
• Exclude criteria: 1) Patients with stump cancer 2) Patients with active infections 3) Patients with hydronephrosis 4) Patients with unstable angina, history of cardiac infarction within 6 months, or arrhythmia that requires medical treatment 5) Patients with serious complications 6) Patients who previously received pelvic radiotherapy 7) Patients with active concomitant malignancy 8) Patients who have undergone surgical staging 9) Patients with psychiatric illness that would prevent informed consent 10) Patients during pregnancy or breast-feeding, or unwilling to the use of contraception 11)Patients who are inappropriate to enter this study with any safety reasons, judged by the treating physician

Related Information

• Primary Sponsor: Japanese Gynecologic Oncology Group
• Source(s) of Monetary Support: Japanese Gynecologic Oncology Group