Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Completed 18 and over NCI GOG-0201 GOG-0201, NCT00054067

Objectives

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

Entry 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

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)

Patient Characteristics:

Age

• 18 and over

Performance status

• GOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

D. Scott McMeekin, MD, Protocol chair		Ph: 405-271-8707

Registry Information
Official Title		Treatment of Patients with Stage IB2 Carcinoma of the Cervix: A Randomized Comparison of Radical Hysterectomy and Tailored Chemo-Radiation Versus Primary Chemo-Radiation
Trial Start Date		2003-02-06
Registered in ClinicalTrials.gov		NCT00054067
Date Submitted to PDQ		2002-12-16
Information Last Verified		2004-09-09
NCI Grant/Contract Number		U10-CA27469

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