Pelvic Exenteration in Treating Patients With Recurrent Cervical Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Evaluation of Pelvic Exenteration in Patients With Recurrent Cervical Cancer

Conditions
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Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Small Cell Carcinoma, Cervical Squamous Cell Carcinoma, Recurrent Cervical Carcinoma

Intervention / Treatment
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* Procedure: Conventional Surgery


Participation Criteria
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Eligibility Criteria
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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 Neoadjuvant chemotherapy followed by surgery with or without radiotherapy or chemotherapy Plans to undergo pelvic exenteration to remove the pelvic disease within 14 days after study entry Deemed to be a good surgical candidate No evidence of distant disease or disease that is felt to be unresectable by physical examination Patients with suspicious pelvic or para-aortic nodal disease as the only site(s) of extrapelvic disease are eligible at the discretion of the surgeon Patients whose surgery is planned solely for managing complications (e.g., rectovaginal fistula, vesicovaginal fistula) of disease or prior therapy are not eligible Patients whose surgery is planned as a prophylactic measure due to a slow or suboptimal clinical or radiographical tumor response during the course of primary therapy are not eligible No distant site of metastases by CT scan or MRI of the abdomen/pelvis OR positron-emission tomography No noncervical primary tumor No prior anterior or posterior pelvic exenteration

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (pelvic exenteration)<br>Patients undergo pelvic exenteration within 14 days after study entry. | Procedure: Conventional Surgery<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | From entry to protocol to death; or for living patients, the date of last contact, up to 93 years | 
| Progression-free survival |  | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |