NCT00217633

Pelvic Exenteration in Treating Patients With Recurrent Cervical Cancer

Prospective Evaluation of Pelvic Exenteration in Patients With Recurrent Cervical Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well pelvic exenteration works in treating patients with recurrent cervical cancer. Pelvic exenteration may be effective in treating recurrent cervical cancer.

Detailed description

PRIMARY OBJECTIVE: I. Correlate progression-free survival and overall survival with tumor size, time interval between primary cancer management and pelvic exenteration, and presence or absence of pelvic sidewall fixation by clinical examination in patients with recurrent cervical cancer treated with pelvic exenteration. SECONDARY OBJECTIVES: I. Determine quality of life of patients treated with this procedure. II. Correlate quality of life with reconstructive technique (e.g., no ostomy or ≥ 1 ostomy) in patients treated with this procedure. OUTLINE: Patients undergo pelvic exenteration within 14 days after study entry. Quality of life is assessed at baseline and at 6, 12, and 24 months after surgery. After completion of study treatment, patients are followed within 30 days, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Conditions

• Cervical Adenocarcinoma
• Cervical Adenosquamous Carcinoma
• Cervical Small Cell Carcinoma
• Cervical Squamous Cell Carcinoma
• Recurrent Cervical Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Conventional Surgery

Timeline

• Start date: 2006-01-01
• Primary completion: 2013-01-01
• First posted: 2005-09-22
• Last updated: 2015-05-29

Locations

39 sites across 2 countries: United States, Spain