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CompletedNCT00217633Updated May 29, 2015

Pelvic Exenteration in Treating Patients With Recurrent Cervical Cancer

A Phase 2 interventional study of Conventional Surgery in Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma and Cervical Small Cell Carcinoma, sponsored by Gynecologic Oncology Group. Completed at 39 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-29.

Sponsored by Gynecologic Oncology Group · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
38
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Cervical Adenocarcinoma
  • Cervical Adenosquamous Carcinoma
  • Cervical Small Cell Carcinoma
  • Cervical Squamous Cell Carcinoma
  • Recurrent Cervical Carcinoma
03

In context

Uterine Cervical Neoplasms

1,927 studies on the registry are indexed under Uterine Cervical Neoplasms; 576 are open to participants now.

This study's enrollment of 38 is below the median of 100 across 1,411 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Gynecologic Oncology Group is the lead sponsor of 188 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    Treatment (pelvic exenteration)

    Patients undergo pelvic exenteration within 14 days after study entry.

    Procedure: Conventional Surgery

Interventions

  • ProcedureConventional Surgery
06

What researchers measure

Primary outcomes

  1. Overall survival

    Time frame: From entry to protocol to death; or for living patients, the date of last contact, up to 93 years

  2. 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 outcomes

  1. 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

07

Study locations

39 sites
  • University of Alabama at Birmingham Cancer Center
    Birmingham, Alabama 35233, United States
  • Colorado Gynecologic Oncology Group
    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
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2006 and a primary completion of Jan 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 20, 2005
First posted
Sep 22, 2005
Start
Jan 2006
Primary completionActual
Jan 2013
Last update
May 29, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00217633
Responsible party
Sponsor
First posted
Sep 22, 2005
Start date
Jan 2006
Primary completion
Jan 2013
Last update
May 29, 2015

Study contacts

D. McMeekin
principal investigator · Gynecologic Oncology Group
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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