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Pelvic Exenteration in Treating Patients With Recurrent Cervical Cancer

Primary Purpose

Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Small Cell Carcinoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Conventional Surgery
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham Cancer Center
  • Colorado Gynecologic Oncology Group
  • Hartford Hospital
  • The Hospital of Central Connecticut
  • Beebe Medical Center
  • Christiana Care Health System-Christiana Hospital
  • Georgia Regents University Medical Center
  • Memorial University Medical Center
  • Indiana University/Melvin and Bren Simon Cancer Center
  • Union Hospital of Cecil County
  • University of Minnesota Medical Center-Fairview
  • Washington University School of Medicine
  • The Cancer Institute of New Jersey Hamilton
  • Rutgers Cancer Institute of New Jersey
  • Roswell Park Cancer Institute
  • University of North Carolina at Chapel Hill
  • Cleveland Clinic Cancer Center/Fairview Hospital
  • Cleveland Clinic Foundation
  • Ohio State University Comprehensive Cancer Center
  • Hillcrest Hospital Cancer Center
  • Lake University Ireland Cancer Center
  • University of Oklahoma Health Sciences Center
  • Cancer Care Associates-Midtown
  • Tulsa Cancer Institute
  • Gynecologic Oncology Group
  • M D Anderson Cancer Center
  • Auburn Regional Medical Center
  • Providence Regional Cancer System-Centralia
  • Saint Francis Hospital
  • Saint Clare Hospital
  • Providence - Saint Peter Hospital
  • Capital Medical Center
  • MultiCare Good Samaritan Hospital
  • MultiCare Allenmore Hospital
  • MultiCare Tacoma General Hospital
  • Northwest CCOP
  • Saint Joseph Medical Center
  • Multicare Health System
  • M D Anderson International Spain

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (pelvic exenteration)

Arm Description

Patients undergo pelvic exenteration within 14 days after study entry.

Outcomes

Primary Outcome Measures

Overall survival
Progression-free survival

Secondary Outcome Measures

Impact of surgery therapy (exenteration and reconstructive surgery type) on quality of life assessed by Functional Assessment of Cancer Therapy-Cervix (FACT-CX)

Full Information

First Posted
September 20, 2005
Last Updated
May 27, 2015
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00217633
Brief Title
Pelvic Exenteration in Treating Patients With Recurrent Cervical Cancer
Official Title
Prospective Evaluation of Pelvic Exenteration in Patients With Recurrent Cervical Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Small Cell Carcinoma, Cervical Squamous Cell Carcinoma, Recurrent Cervical Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (pelvic exenteration)
Arm Type
Experimental
Arm Description
Patients undergo pelvic exenteration within 14 days after study entry.
Intervention Type
Procedure
Intervention Name(s)
Conventional Surgery
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
From entry to protocol to death; or for living patients, the date of last contact, up to 93 years
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
D. McMeekin
Organizational Affiliation
Gynecologic Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Colorado Gynecologic Oncology Group
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
The Hospital of Central Connecticut
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06050
Country
United States
Facility Name
Beebe Medical Center
City
Lewes
State/Province
Delaware
ZIP/Postal Code
19958
Country
United States
Facility Name
Christiana Care Health System-Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Georgia Regents University Medical Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Memorial University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
Country
United States
Facility Name
Indiana University/Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Union Hospital of Cecil County
City
Elkton MD
State/Province
Maryland
ZIP/Postal Code
21921
Country
United States
Facility Name
University of Minnesota Medical Center-Fairview
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
The Cancer Institute of New Jersey Hamilton
City
Hamilton
State/Province
New Jersey
ZIP/Postal Code
08690
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Cleveland Clinic Cancer Center/Fairview Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Hillcrest Hospital Cancer Center
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Lake University Ireland Cancer Center
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Cancer Care Associates-Midtown
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Tulsa Cancer Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74146
Country
United States
Facility Name
Gynecologic Oncology Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Auburn Regional Medical Center
City
Auburn
State/Province
Washington
ZIP/Postal Code
98001
Country
United States
Facility Name
Providence Regional Cancer System-Centralia
City
Centralia
State/Province
Washington
ZIP/Postal Code
98531
Country
United States
Facility Name
Saint Francis Hospital
City
Federal Way
State/Province
Washington
ZIP/Postal Code
98003
Country
United States
Facility Name
Saint Clare Hospital
City
Lakewood
State/Province
Washington
ZIP/Postal Code
98499
Country
United States
Facility Name
Providence - Saint Peter Hospital
City
Olympia
State/Province
Washington
ZIP/Postal Code
98506-5166
Country
United States
Facility Name
Capital Medical Center
City
Olympia
State/Province
Washington
ZIP/Postal Code
98507
Country
United States
Facility Name
MultiCare Good Samaritan Hospital
City
Puyallup
State/Province
Washington
ZIP/Postal Code
98372
Country
United States
Facility Name
MultiCare Allenmore Hospital
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
MultiCare Tacoma General Hospital
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Northwest CCOP
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Saint Joseph Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Multicare Health System
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98415
Country
United States
Facility Name
M D Anderson International Spain
City
Madrid
ZIP/Postal Code
28033
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Pelvic Exenteration in Treating Patients With Recurrent Cervical Cancer

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