• Overall survival as measured by Kaplan Meier after each course, every 3 months for 1 year, every 6 months for 4 years, and then annually [ Designated as safety issue: No ]
  

• Progression-free survival as measured by Kaplan Meier and RECIST after each course, every 3 months for 1 year, every 6 months for 4 years, and then annually [ Designated as safety issue: No ]
  
• Toxicity as measured by NCIC Common Toxicity Criteria v2.0 after each course [ Designated as safety issue: Yes ]
  
• Health-related quality of life as measured by Quality of Life Questionnaire-C30 before randomization, after completion of study treatment, every 3 months for 1 year, and then every 6 months for 4 years [ Designated as safety issue: No ]
  

OBJECTIVES:

• Compare the overall and progression-free survival of patients with stage IB2, IIA, or IIB cervical cancer treated with neoadjuvant cisplatin-based chemotherapy followed by radical hysterectomy vs standard therapy comprising concurrent radiotherapy and cisplatin-based chemotherapy.
• Compare the toxicity of these regimens in these patients.
• Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, FIGO stage, age (18 to 50 vs 51 to 75), and histological subtype (adenomatous vs non-adenomatous component). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive neoadjuvant cisplatin-based chemotherapy on day 1. Treatment repeats every 21 days. Within 6 weeks after the last chemotherapy course, patients undergo a type III-V Piver-Rutledge radical hysterectomy. Patients with positive lymph nodes or tumor invasion into the parametria or less than 5 mm from the resection borders after surgery receive standard adjuvant external beam radiotherapy once daily, 5 days a week, for 5-5.6 weeks (25-28 treatment days) followed by external boost radiotherapy or brachytherapy for 1 or 2 days.
• Arm II: Patients receive standard therapy comprising radiotherapy as in arm I concurrently with cisplatin-based chemotherapy once weekly for 6 weeks. Adjuvant hysterectomy is allowed, but not recommended, in case of histologically proven residual tumor.

Treatment in both arms continues in the absence of disease progression or unacceptable toxicity. For patients in both arms, cisplatin may be combined with other chemotherapeutics as long as the minimum platinum dose is given.

Quality of life is assessed at baseline, after completion of the last chemotherapy course (arm I) or 4-8 weeks after completion of chemoradiotherapy (arm II), every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.

Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 686 patients (343 per treatment arm) will be accrued for this study within 3.8 years.

DISEASE CHARACTERISTICS:

• Histologically confirmed cervical cancer, including the following subtypes:

  • Squamous cell carcinoma
  • Adenosquamous cell carcinoma
  • Adenocarcinoma (excluding small cell, clear cell, and other rare variants of the classical adenocarcinoma)
• FIGO stage IB2, IIA (greater than 4 cm), or IIB

PATIENT CHARACTERISTICS:

Age:

• 18 to 75

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count greater than 1,500/mm^3
• Platelet count greater than 100,000/mm^3

Hepatic:

• Bilirubin less than 1.46 mg/dL

Renal:

• Creatinine clearance greater than 60 mL/min

Other:

• No other prior or concurrent malignancy except adequately treated basal cell skin cancer
• No psychological, familial, sociological, or geographical condition that would preclude study
• Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy

Surgery:

• Not specified

Other:

• No other concurrent anticancer agent