Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Stage I Cancer of the Cervix

Gynecologic Oncology Group (GOG)

Status and phase: Terminated; Phase 3

Conditions: Cervical Cancer

Treatments: Procedure: adjuvant therapy; Procedure: conventional surgery; Radiation: brachytherapy; Drug: cisplatin; Radiation: radiation therapy

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00054067

GOG-0201

CDR0000269821

Details and patient eligibility

About

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of radiation therapy combined with chemotherapy, with or without surgery, is more effective in treating early cancer of the cervix.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery followed by different regimens of radiation therapy and chemotherapy with that of chemotherapy and radiation therapy alone in treating patients who have stage I cancer of the cervix.

Full description

OBJECTIVES:

• Compare progression-free survival and survival of patients with stage IB2 carcinoma of the cervix after radical hysterectomy with tailored chemoradiotherapy vs primary chemoradiotherapy.
• Compare the toxicity of these regimens in these patients.
• Compare the health-related quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: (Surgery followed by chemoradiotherapy): Patients undergo exploratory laparotomy followed by radical hysterectomy and bilateral pelvic and para-aortic lymphadenectomy. Depending on the findings at surgery, the radical hysterectomy and lymphadenectomy are either completed or aborted.

  • Aborted hysterectomy: Patients with aborted hysterectomy are assigned to 1 of 3 groups, depending on the findings at surgery.

    • Group 1: Within 4 weeks of surgery, patients undergo pelvic radiotherapy 5 times weekly for 4-6 weeks and intracavitary irradiation during or after external radiotherapy. Patients also receive concurrent cisplatin IV over 1 hour once weekly for a total of 5-6 doses.
    • Group 2: Patients receive radiotherapy and cisplatin as in group 1 with additional extended field radiotherapy.
    • Group 3: Patients receive further treatment at the discretion of the investigator.

  • Completed hysterectomy: Patients completing the radical hysterectomy are assigned to 1 of 3 groups, depending on the findings at surgery.

    • Group A: Patients receive treatment as in group 1 above without intracavity irradiation.
    • Group B: Patients receive treatment as in group 2 above without intracavity irradiation.
    • Group C: Patients receive no further treatment.

• Arm II (Primary chemoradiotherapy): Patients undergo pelvic radiotherapy 5 times weekly for 4-6 weeks and intracavity irradiation during or after external radiotherapy. Patients also receive concurrent cisplatin IV over 1 hour once weekly for a total of 6 doses.

Quality of life is assessed at baseline, during week 5 of therapy, and then at 3, 6, and 12 months.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 740 patients (370 per treatment arm) will be accrued for this study within 7.5 years.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed stage IB2 invasive carcinoma of the uterine cervix of one of the following types:

  • Squamous cell carcinoma
  • Adenocarcinoma
  • Adenosquamous carcinoma

• Primary, previously untreated disease

• Exophytic cervical lesions greater than 4 cm in diameter OR

• Cervical expansion to greater than 4 cm in diameter, presumed to be the result of principal involvement with cancer

• No evidence of extrauterine disease other than pelvic lymph node involvement (by clinical and radiographic examinations)

• No para-aortic lymph nodal disease (suspected on CT scan, MRI, positron-emission tomography, or lymphangiogram) unless nodes are confirmed to be pathologically negative (by CT-guided biopsy or extraperitoneal lymph node dissection)

• Eligible for radical hysterectomy and lymph node dissection

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• GOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic

• Bilirubin no greater than 1.5 times normal
• SGOT no greater than 3 times normal
• Alkaline phosphatase no greater than 3 times normal

Renal

• Creatinine no greater than 2.0 mg/dL
• No renal abnormalities requiring modification of radiation fields

Gastrointestinal

• No gastrointestinal bleeding
• No intestinal obstruction

Other

• Not pregnant
• Negative pregnancy test
• No septicemia or severe infection
• No other invasive malignancy with any evidence of disease within the past 5 years except nonmelanoma skin cancer
• No circumstances that would preclude study completion or required follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy

Surgery

• See Disease Characteristics
• No prior hysterectomy (total or subtotal)