Pelvic Exenteration in Treating Patients With Recurrent Cervical Cancer
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|ClinicalTrials.gov Identifier: NCT00217633|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : May 29, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Small Cell Carcinoma Cervical Squamous Cell Carcinoma Recurrent Cervical Carcinoma||Procedure: Conventional Surgery||Phase 2|
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Evaluation of Pelvic Exenteration in Patients With Recurrent Cervical Cancer|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||January 2013|
Experimental: Treatment (pelvic exenteration)
Patients undergo pelvic exenteration within 14 days after study entry.
Procedure: Conventional Surgery
- 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 ]
- Impact of surgery therapy (exenteration and reconstructive surgery type) on quality of life assessed by Functional Assessment of Cancer Therapy-Cervix (FACT-CX) [ Time Frame: At baseline, 6, 12, and 24 months post exenteration ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00217633
Show 39 Study Locations
|Principal Investigator:||D. McMeekin||Gynecologic Oncology Group|