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Cervical AdenocarcinomaPhase 2NCT00217633

Pelvic Exenteration in Treating Patients With Recurrent Cervical Cancer

A Phase 2 study testing Conventional Surgery in people with Cervical Adenocarcinoma and Cervical Adenosquamous Carcinoma, run by Gynecologic Oncology Group at 39 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Conventional Surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
39 sitesin 2 countries
Study dates
Jan 2006to Jan 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 20Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

39 sites in 2 countries.

39 sites in 2 countries

United States38 sites

  • Auburn Regional Medical Center

    Auburn, Washington, 98001

  • Georgia Regents University Medical Center

    Augusta, Georgia, 30912

  • Colorado Gynecologic Oncology Group

    Aurora, Colorado, 80010

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Union Hospital of Cecil County

    Elkton MD, Maryland, 21921

  • Saint Francis Hospital

    Federal Way, Washington, 98003

  • The Cancer Institute of New Jersey Hamilton

    Hamilton, New Jersey, 08690

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Saint Clare Hospital

    Lakewood, Washington, 98499

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

  • Lake University Ireland Cancer Center

    Mentor, Ohio, 44060

  • University of Minnesota Medical Center-Fairview

    Minneapolis, Minnesota, 55455

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06050

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Providence - Saint Peter Hospital

    Olympia, Washington, 98506-5166

  • Capital Medical Center

    Olympia, Washington, 98507

  • Gynecologic Oncology Group

    Philadelphia, Pennsylvania, 19103

  • MultiCare Good Samaritan Hospital

    Puyallup, Washington, 98372

  • Memorial University Medical Center

    Savannah, Georgia, 31404

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • MultiCare Allenmore Hospital

    Tacoma, Washington, 98405

  • MultiCare Tacoma General Hospital

    Tacoma, Washington, 98405

  • Northwest CCOP

    Tacoma, Washington, 98405

  • Saint Joseph Medical Center

    Tacoma, Washington, 98405

  • Multicare Health System

    Tacoma, Washington, 98415

  • Cancer Care Associates-Midtown

    Tulsa, Oklahoma, 74104

  • Tulsa Cancer Institute

    Tulsa, Oklahoma, 74146

Other trials in United States

Spain1 site

  • M D Anderson International Spain

    Madrid, Madrid, 28033

Other trials in Spain

About this study

Official title: Prospective Evaluation of Pelvic Exenteration in Patients With Recurrent Cervical Cancer

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:

  1. 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:

  1. 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.

Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00217633
Study groupRoleWhat they receive
Treatment (pelvic exenteration)ExperimentalPatients undergo pelvic exenteration within 14 days after study entry.
Receives: Procedure: Conventional Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

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

  2. Progression-free survival

    Measured: 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)

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

    Measured: At baseline, 6, 12, and 24 months post exenteration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startJan 2006
  3. Primary completionJan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00217633
Sponsor's protocol ID
GOG-0222
Other IDs
NCI-2009-00593, CDR0000442396, GOG-0222, GOG-0222, U10CA027469
Status last verified
May 2015
First submitted
20 Sep 2005
Last updated
29 May 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Conventional Surgery in people with Cervical Adenocarcinoma and Cervical Adenosquamous Carcinoma, run by Gynecologic Oncology Group at 39 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: From entry to protocol to death; or for living patients, the date of last contact, up to 93 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00217633.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2015.

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