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Pelvic Exenteration in Treating Patients With Recurrent Cervical Cancer

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ClinicalTrials.gov Identifier: NCT00217633
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : May 29, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

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.

Condition or disease Intervention/treatment Phase
Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Small Cell Carcinoma Cervical Squamous Cell Carcinoma Recurrent Cervical Carcinoma Procedure: Conventional Surgery Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Pelvic Exenteration in Patients With Recurrent Cervical Cancer
Study Start Date : January 2006
Actual Primary Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Experimental: Treatment (pelvic exenteration)
Patients undergo pelvic exenteration within 14 days after study entry.
Procedure: Conventional Surgery



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00217633


  Show 39 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: D. McMeekin Gynecologic Oncology Group

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Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00217633     History of Changes
Other Study ID Numbers: GOG-0222
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 )
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Adenocarcinoma
Uterine Cervical Neoplasms
Carcinoma, Small Cell
Small Cell Lung Carcinoma
Carcinoma, Adenosquamous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Complex and Mixed