Pelvic Exenteration in Treating Patients With Recurrent Cervical Cancer

Cervical Adenocarcinoma Clinical Trial

Official title:

Prospective Evaluation of Pelvic Exenteration in Patients With Recurrent Cervical Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00217633
• Other study ID #: GOG-0222
• Secondary ID: NCI-2009-00593CD
• Status: Completed
• Phase: Phase 2
• First received: September 20, 2005
• Last updated: May 27, 2015
• Start date: January 2006

Study information

• Verified date: May 2015
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma
• Carcinoma, Adenosquamous
• Carcinoma, Small Cell
• Carcinoma, Squamous Cell
• Cervical Adenocarcinoma
• Cervical Adenosquamous Carcinoma
• Cervical Small Cell Carcinoma
• Cervical Squamous Cell Carcinoma
• Recurrent Cervical Carcinoma
• Small Cell Lung Carcinoma
• Uterine Cervical Neoplasms

Intervention

Procedure:
• Conventional Surgery

Locations

Country	Name	City	State
Spain	M D Anderson International Spain	Madrid
United States	Auburn Regional Medical Center	Auburn	Washington
United States	Georgia Regents University Medical Center	Augusta	Georgia
United States	Colorado Gynecologic Oncology Group	Aurora	Colorado
United States	University of Alabama at Birmingham Cancer Center	Birmingham	Alabama
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Providence Regional Cancer System-Centralia	Centralia	Washington
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Cleveland Clinic Cancer Center/Fairview Hospital	Cleveland	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	Union Hospital of Cecil County	Elkton MD	Maryland
United States	Saint Francis Hospital	Federal Way	Washington
United States	The Cancer Institute of New Jersey Hamilton	Hamilton	New Jersey
United States	Hartford Hospital	Hartford	Connecticut
United States	M D Anderson Cancer Center	Houston	Texas
United States	Indiana University/Melvin and Bren Simon Cancer Center	Indianapolis	Indiana
United States	Saint Clare Hospital	Lakewood	Washington
United States	Beebe Medical Center	Lewes	Delaware
United States	Hillcrest Hospital Cancer Center	Mayfield Heights	Ohio
United States	Lake University Ireland Cancer Center	Mentor	Ohio
United States	University of Minnesota Medical Center-Fairview	Minneapolis	Minnesota
United States	The Hospital of Central Connecticut	New Britain	Connecticut
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Christiana Care Health System-Christiana Hospital	Newark	Delaware
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Capital Medical Center	Olympia	Washington
United States	Providence - Saint Peter Hospital	Olympia	Washington
United States	Gynecologic Oncology Group	Philadelphia	Pennsylvania
United States	MultiCare Good Samaritan Hospital	Puyallup	Washington
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Memorial University Medical Center	Savannah	Georgia
United States	MultiCare Allenmore Hospital	Tacoma	Washington
United States	Multicare Health System	Tacoma	Washington
United States	MultiCare Tacoma General Hospital	Tacoma	Washington
United States	Northwest CCOP	Tacoma	Washington
United States	Saint Joseph Medical Center	Tacoma	Washington
United States	Cancer Care Associates-Midtown	Tulsa	Oklahoma
United States	Tulsa Cancer Institute	Tulsa	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		From entry to protocol to death; or for living patients, the date of last contact, up to 93 years	No
Primary	Progression-free survival		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	No
Secondary	Impact of surgery therapy (exenteration and reconstructive surgery type) on quality of life assessed by Functional Assessment of Cancer Therapy-Cervix (FACT-CX)		At baseline, 6, 12, and 24 months post exenteration	No