Pelvic Exenteration in Treating Patients With Recurrent Cervical Cancer

Gynecologic Oncology Group (GOG)

Status and phase: Completed; Phase 2

Conditions: Cervical Adenosquamous Carcinoma; Cervical Adenocarcinoma; Cervical Squamous Cell Carcinoma; Recurrent Cervical Carcinoma; Cervical Small Cell Carcinoma

Treatments: Procedure: Conventional Surgery

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00217633

U10CA027469 (U.S. NIH Grant/Contract)

NCI-2009-00593 (Registry Identifier)

GOG-0222 (Other Identifier)

CDR0000442396

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Treatment (pelvic exenteration)

Experimental group

Description:

Patients undergo pelvic exenteration within 14 days after study entry.

Treatment:

Procedure: Conventional Surgery