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

Alternate Title

Radiation Therapy and Cisplatin With or Without Epoetin Alfa in Treating Patients With Cervical Cancer and Anemia

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care, Treatment Closed Not specified NCI GOG-0191 CAN-NCIC-CX4, NCT00017004, GOG-0191, CX4

Objectives

1. Assess the efficacy of raising and maintaining hemoglobin (Hgb) levels above 12.0 g/dL with epoetin alfa vs maintaining Hgb levels above 10.0 g/dL without epoetin alfa on progression-free survival, overall survival, and local control in anemic patients with cervical cancer receiving concurrent radiotherapy and cisplatin.
2. Compare the quality of life of patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
  • Stage IIB, IIIB, or IVA
  • Primary, previously untreated disease



• Hemoglobin less than 14 g/dL at presentation



• Negative, non-suspicious para-aortic nodes determined by lymphangiogram, CT scan, MRI, or lymphadenectomy



• Eligible for treatment with radical intent involving concurrent cisplatin and pelvic radiotherapy



• No involvement of the lower third of vagina



• No carcinoma of the cervical stump

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

Surgery:

• Not specified

Patient Characteristics:

Age:

• Not specified

Performance status:

• GOG 0-3

Life expectancy:

• Not specified

Hematopoietic:

• See Disease Characteristics
• 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

Cardiovascular:

• No uncontrolled hypertension
• No history of thrombotic vascular events (e.g., deep vein thrombosis or myocardial infarction)
• No active hemolysis

Pulmonary:

• No history of pulmonary embolism

Other:

• No septicemia or severe infection
• No circumstances that would preclude study participation
• No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
• No history of hypersensitivity to epoetin alfa or human albumin
• No diagnosis of vitamin B₁₂ or folic acid deficiency
• No recent (within the past 3 months) or uncontrolled seizure disorder
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Expected Enrollment

A total of 460 patients will be accrued for this study within 3.5 years.

Outline

This is a randomized study. Patients are stratified according to stage (IIB vs IIIB vs IVA), method of brachytherapy (low-dose vs high-dose), and surgical staging of para-aortic nodes (yes vs no). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo radiotherapy comprising pelvic external beam radiotherapy daily five days a week for 5 weeks, followed by either 1 or 2 implants of low-dose rate intracavitary brachytherapy or 5 fractions of high-dose rate intracavitary brachytherapy, followed by 3-5 days of parametrial boost radiotherapy. Patients receive cisplatin IV concurrently with pelvic external beam radiotherapy on days 1, 8, 15, 22, 29, and once during the week of parametrial boost radiotherapy.



• Arm II: Patients undergo radiotherapy and chemotherapy as in arm I. Additionally, patients receive epoetin alfa subcutaneously once weekly concurrently with radiotherapy and chemotherapy.

Quality of life is assessed at baseline, during weeks 3 and 6, within 1 week of last brachytherapy, and every 3 months for 2 years.

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

Gillian Thomas, BSc, MD, FRCPC, FRCR (Hon), Protocol chair		Ph: 416-480-6165

NCIC-Clinical Trials Group

Peter Craighead, MD, Protocol chair		Ph: 403-944-1651 Email: peterch@cancerboard.ab.ca

Registry Information
Official Title		Phase III Trial to Evaluate the Efficacy of Maintaining Hemoglobin Levels Above 120 G/L with Erythropoietin Versus Above 100 G/L Without Erythropoietin in Anemic Patients Receiving Concurrent Radiation and Cisplatin for Cervical Cancer
Trial Start Date		2001-08-20
Registered in ClinicalTrials.gov		NCT00017004
Date Submitted to PDQ		2001-04-02
Information Last Verified		2004-05-10
NCI Grant/Contract Number		U10-CA27469

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