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Study Summary
No. GOG 0222:.......Cervix......Pedro Ramirez......Gynecologic Oncology
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Study Summary Title
Study Summary
Number:
GOG 0222
Study Title:Prospective Evaluation of Pelvic Exenteration in Patients with Recurrent Cervical Cancer
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Physician New Patient Referral
Name:Pedro RamirezPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Gynecologic OncologyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-3357
Contact us about clinical trials
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General Information
Disease Group:CervixSupported By:N/A
Phase of Study:N/AReturn
Visit:
Every 3 months for the first two years, every six months for years 3 through 5
and annually thereafter.
Treatment
Agents:
NoneHome Care:none
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
Pelvic exenteration surgery requires two weeks or more hospitalization.
Description/
Intervention:
The goal of this clinical research study is to find out if certain
characteristics about your type of cancer can help researchers predict the
long-term outcomes of pelvic exenteration surgery. Researchers will study the
type of surgery completed and procedures used to find out which are most
effective and safe. Researchers will also study how this surgery affects your
quality of life.
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Study Objectives / Outcomes
1. To determine whether progression free survival (PFS) and overall survival (OS), post exenteration, may be predicted based on a model with selected clinical-pathologic factors. The model will include: time interval between primary cervical cancer management and exenteration, central pelvic tumor size, and findings of pelvic sidewall fixation at clinical examination.

2. To explore the relation ship between quality of life (QOL) and surgical procedures, categorized by continent urinary diversion and/or lack of permanent stoma following exenteration.

3. To explore the QOL associated with pelvic exenteration.
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Study Status Information
Study Activation / Registration Date:03/30/2006
IRB Review and Approval Date:03/15/2006
Study Type:Not Applicable
Recruitment Status:Closed
Projected Accrual:275
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Patients who have recurrent or persistent cervical cancer (any histology), with suspected or ducumented central pelvic disease, with or without sidewall disease, for which exenterative surgery is offered to remove the pelvic disease. (1) Recurrence will be defined as the reappearance of disease following a complete clinical response of >/= 1 month duration. (2) Persistence will be defined as presence of disease verified pathologically from a biopsy taken >/= 3 months from completion of primary therapy.

2) All patients must have been previously treated for the primary management of cervical cancer or its recurrence (prior therapy includes: surgery with or without postoperative radiation with/without chemotherapy, primary radiation with/without chemotherapy, neoadjuvant chemotherapy followed by surgery, or neoadjuvant chemotherapy followed by surgery +/- radiation or chemoradiation.

3) Patients must have undergone appropriate examination and imaging studies to evaluate for the presence of metastatic disease, and no distant site of metastases is identified. Patients with suspicious pelvic or para-aortic nodal disease as the only site(s) of extrapelvic disease will be allowed at the discretion of the surgeon.

4) Patients must be able and willing to complete pre-and post-operative quality of life assessments.

5) Patients must have met the pre-operative assessment requirements.

6) Patients who have met the pre-entry requirements as indicated in the Patient/Participant Evaluation section of this abstract.

7) Patients must be deemed a good surgical candidate (at surgeon's discretion).

8) Patients who have signed an approved informed consent and authorization permitting release of personal health information.

Exclusion Criteria:1) Non-cervical primary tumors.

2) Patients who have previously untreated cervical cancer (primary exenteration will not be allowed).

3) Patients in which pelvic surgery or reconstruction will be performed solely for the puropse of managing complications of disease or prior therapy (rectovaginal fistula, vesicovaginal fistula, etc).

4) Patients who will undergo "prophylactic" exenteration based on a slowly or suboptimally responding tumor response (clionically or radiographically) during the course of primary therapy.

5) Patients who have previously undergone prior anterior or posterior exenteration.

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Links
Registration Number: NCT00217633
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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