Prospective Evaluation of Pelvic Exenteration in Patients With Recurrent Cervical Cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Cervical Adenocarcinoma
- Sponsor
- Gynecologic Oncology Group
- Enrollment
- 38
- Locations
- 39
- Primary Endpoint
- Overall survival
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of cervical cancer
- •Any histology
- •Documented or suspected central pelvic disease with or without pelvic sidewall fixation from tumor and/or radiation fibrosis
- •Meets 1 of the following stage criteria:
- •Recurrent disease, defined as reappearance of disease after a complete clinical response lasting ≥ 1 month
- •Persistent disease, defined as presence of disease by biopsy ≥ 3 months after completion of primary therapy
- •Must have received prior primary treatment, including any of the following:
- •Surgery with or without post operative radiotherapy with or without chemotherapy
- •Primary radiotherapy with or without chemotherapy
- •Neoadjuvant chemotherapy followed by surgery
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Overall survival
Time Frame: From entry to protocol to death; or for living patients, the date of last contact, up to 93 years
Progression-free survival
Time Frame: From study entry to date of reappearance or increasing parameters of disease or death, or to date of last contact for patients without disease progression, up to 93 years
Secondary Outcomes
- Impact of surgery therapy (exenteration and reconstructive surgery type) on quality of life assessed by Functional Assessment of Cancer Therapy-Cervix (FACT-CX)(At baseline, 6, 12, and 24 months post exenteration)