Cervical Adenocarcinoma Clinical Trial
Official title:
Prospective Evaluation of Pelvic Exenteration in Patients With Recurrent Cervical Cancer
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.
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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