A Phase 2 interventional study of Conventional Surgery in Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma and Cervical Small Cell Carcinoma, sponsored by Gynecologic Oncology Group. Completed at 39 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-29.
Sponsored by Gynecologic Oncology Group · Phase 2, Interventional, and Treatment
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.
1,927 studies on the registry are indexed under Uterine Cervical Neoplasms; 576 are open to participants now.
This study's enrollment of 38 is below the median of 100 across 1,411 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Gynecologic Oncology Group is the lead sponsor of 188 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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 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
The record gives a start of Jan 2006 and a primary completion of Jan 2013. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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