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Prospective Evaluation of Pelvic Exenteration in Patients With Recurrent Cervical Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Cervical Cancer

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Trial Information

Prospective Evaluation of Pelvic Exenteration in Patients With Recurrent Cervical Cancer


OBJECTIVES:

Primary

- 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

- Determine quality of life of patients treated with this procedure.

- 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.

PROJECTED ACCRUAL: A total of 275 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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 postoperative 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

PATIENT CHARACTERISTICS:

Age

- Over 18

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

Other

- No noncervical primary tumor

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- See Disease Characteristics

Endocrine therapy

- Not specified

Radiotherapy

- See Disease Characteristics

Surgery

- See Disease Characteristics

- No prior anterior or posterior pelvic exenteration

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Correlation of 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

Safety Issue:

No

Principal Investigator

D. Scott McMeekin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Oklahoma University Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000442396

NCT ID:

NCT00217633

Start Date:

January 2006

Completion Date:

Related Keywords:

  • Cervical Cancer
  • cervical adenocarcinoma
  • cervical adenosquamous cell carcinoma
  • cervical small cell carcinoma
  • cervical squamous cell carcinoma
  • recurrent cervical cancer
  • Uterine Cervical Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut  06050
Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Providence Saint Joseph Medical Center - BurbankBurbank, California  91505
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
SUNY Downstate Medical CenterBrooklyn, New York  11203
MBCCOP - Medical College of Georgia Cancer CenterAugusta, Georgia  30912-3730
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Helen and Harry Gray Cancer Center at Hartford HospitalHartford, Connecticut  06102-5037
Women's Cancer Center - Lake MeadLas Vegas, Nevada  89102
Cleveland Clinic Cancer Center at Fairview HospitalCleveland, Ohio  44111
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240
Hillcrest Cancer Center at Hillcrest HospitalMayfield Heights, Ohio  44124
Cancer Care Associates - Saint Francis CampusTulsa, Oklahoma  74136-1929
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
UAB Comprehensive Cancer CenterBirmingham, Alabama  35294
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
Union Hospital Cancer Program at Union HospitalElkton MD, Maryland  21921
Colorado Gynecologic Oncology Group, PCAurora, Colorado  80010
Renown Institute for Cancer at Renown Regional Medical CenterReno, Nevada  89502