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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00217633
Other study ID # GOG-0222
Secondary ID NCI-2009-00593CD
Status Completed
Phase Phase 2
First received September 20, 2005
Last updated May 27, 2015
Start date January 2006

Study information

Verified date May 2015
Source Gynecologic Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of cervical cancer

- Any histology

- Documented or suspected central pelvic disease with or without pelvic sidewall fixation from tumor and/or radiation fibrosis

- Meets 1 of the following stage criteria:

- Recurrent disease, defined as reappearance of disease after a complete clinical response lasting = 1 month

- Persistent disease, defined as presence of disease by biopsy = 3 months after completion of primary therapy

- Must have received prior primary treatment, including any of the following:

- Surgery with or without post operative radiotherapy with or without chemotherapy

- Primary radiotherapy with or without chemotherapy

- Neoadjuvant chemotherapy followed by surgery

- Neoadjuvant chemotherapy followed by surgery with or without radiotherapy or chemotherapy

- Plans to undergo pelvic exenteration to remove the pelvic disease within 14 days after study entry

- Deemed to be a good surgical candidate

- No evidence of distant disease or disease that is felt to be unresectable by physical examination

- Patients with suspicious pelvic or para-aortic nodal disease as the only site(s) of extrapelvic disease are eligible at the discretion of the surgeon

- 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
Conventional Surgery


Locations

Country Name City State
Spain M D Anderson International Spain Madrid
United States Auburn Regional Medical Center Auburn Washington
United States Georgia Regents University Medical Center Augusta Georgia
United States Colorado Gynecologic Oncology Group Aurora Colorado
United States University of Alabama at Birmingham Cancer Center Birmingham Alabama
United States Roswell Park Cancer Institute Buffalo New York
United States Providence Regional Cancer System-Centralia Centralia Washington
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States Cleveland Clinic Cancer Center/Fairview Hospital Cleveland Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Union Hospital of Cecil County Elkton MD Maryland
United States Saint Francis Hospital Federal Way Washington
United States The Cancer Institute of New Jersey Hamilton Hamilton New Jersey
United States Hartford Hospital Hartford Connecticut
United States M D Anderson Cancer Center Houston Texas
United States Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana
United States Saint Clare Hospital Lakewood Washington
United States Beebe Medical Center Lewes Delaware
United States Hillcrest Hospital Cancer Center Mayfield Heights Ohio
United States Lake University Ireland Cancer Center Mentor Ohio
United States University of Minnesota Medical Center-Fairview Minneapolis Minnesota
United States The Hospital of Central Connecticut New Britain Connecticut
United States Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
United States Christiana Care Health System-Christiana Hospital Newark Delaware
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Capital Medical Center Olympia Washington
United States Providence - Saint Peter Hospital Olympia Washington
United States Gynecologic Oncology Group Philadelphia Pennsylvania
United States MultiCare Good Samaritan Hospital Puyallup Washington
United States Washington University School of Medicine Saint Louis Missouri
United States Memorial University Medical Center Savannah Georgia
United States MultiCare Allenmore Hospital Tacoma Washington
United States Multicare Health System Tacoma Washington
United States MultiCare Tacoma General Hospital Tacoma Washington
United States Northwest CCOP Tacoma Washington
United States Saint Joseph Medical Center Tacoma Washington
United States Cancer Care Associates-Midtown Tulsa Oklahoma
United States Tulsa Cancer Institute Tulsa Oklahoma

Sponsors (2)

Lead Sponsor Collaborator
Gynecologic Oncology Group National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival From entry to protocol to death; or for living patients, the date of last contact, up to 93 years No
Primary Progression-free survival 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 No
Secondary Impact of surgery therapy (exenteration and reconstructive surgery type) on quality of life assessed by Functional Assessment of Cancer Therapy-Cervix (FACT-CX) At baseline, 6, 12, and 24 months post exenteration No
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