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About
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.
Full 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.
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria:
Diagnosis of cervical cancer
Meets 1 of the following stage criteria:
Must have received prior primary treatment, including any of the following:
Plans to undergo pelvic exenteration to remove the pelvic disease within 14 days after study entry
Deemed to be a good surgical candidate
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
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38 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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