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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-00593 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000442396 | |||
| GOG-0222 | Other Identifier | Gynecologic Oncology Group | |
| GOG-0222 | Other Identifier | CTEP | |
| U10CA027469 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (pelvic exenteration) | Experimental | Patients undergo pelvic exenteration within 14 days after study entry. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Surgery | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | From entry to protocol to death; or for living patients, the date of last contact, up to 93 years | |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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 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
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| Name | Affiliation | Role |
|---|---|---|
| D. McMeekin | Gynecologic Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | 35233 | United States | ||
| Colorado Gynecologic Oncology Group |
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| Aurora |
| Colorado |
| 80010 |
| United States |
| Hartford Hospital | Hartford | Connecticut | 06102 | United States |
| The Hospital of Central Connecticut | New Britain | Connecticut | 06050 | United States |
| Beebe Medical Center | Lewes | Delaware | 19958 | United States |
| Christiana Care Health System-Christiana Hospital | Newark | Delaware | 19718 | United States |
| Georgia Regents University Medical Center | Augusta | Georgia | 30912 | United States |
| Memorial University Medical Center | Savannah | Georgia | 31404 | United States |
| Indiana University/Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| Union Hospital of Cecil County | Elkton MD | Maryland | 21921 | United States |
| University of Minnesota Medical Center-Fairview | Minneapolis | Minnesota | 55455 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| The Cancer Institute of New Jersey Hamilton | Hamilton | New Jersey | 08690 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland | Ohio | 44111 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| Hillcrest Hospital Cancer Center | Mayfield Heights | Ohio | 44124 | United States |
| Lake University Ireland Cancer Center | Mentor | Ohio | 44060 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Cancer Care Associates-Midtown | Tulsa | Oklahoma | 74104 | United States |
| Tulsa Cancer Institute | Tulsa | Oklahoma | 74146 | United States |
| Gynecologic Oncology Group | Philadelphia | Pennsylvania | 19103 | United States |
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Auburn Regional Medical Center | Auburn | Washington | 98001 | United States |
| Providence Regional Cancer System-Centralia | Centralia | Washington | 98531 | United States |
| Saint Francis Hospital | Federal Way | Washington | 98003 | United States |
| Saint Clare Hospital | Lakewood | Washington | 98499 | United States |
| Providence - Saint Peter Hospital | Olympia | Washington | 98506-5166 | United States |
| Capital Medical Center | Olympia | Washington | 98507 | United States |
| MultiCare Good Samaritan Hospital | Puyallup | Washington | 98372 | United States |
| MultiCare Allenmore Hospital | Tacoma | Washington | 98405 | United States |
| MultiCare Tacoma General Hospital | Tacoma | Washington | 98405 | United States |
| Northwest CCOP | Tacoma | Washington | 98405 | United States |
| Saint Joseph Medical Center | Tacoma | Washington | 98405 | United States |
| Multicare Health System | Tacoma | Washington | 98415 | United States |
| M D Anderson International Spain | Madrid | Madrid | 28033 | Spain |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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