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

NCT ID: NCT00017004

Last Updated: 2017-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-08-31

Brief Summary

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Epoetin alfa may stimulate red blood cell production to treat anemia in patients who have received chemotherapy and/or radiation therapy for cervical cancer. Randomized phase III trial to study the effectiveness of epoetin alfa in treating anemia in patients who have cervical cancer.

Detailed Description

OBJECTIVES:

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. Compare the quality of life of patients treated with these regimens.

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.

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

Conditions

Anemia; Cervical Adenocarcinoma; Cervical Adenosquamous Carcinoma; Cervical Squamous Cell Carcinoma; Drug Toxicity; Radiation Toxicity; Stage IIB Cervical Cancer; Stage III Cervical Cancer; Stage IVA Cervical Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

External Beam Radiation Therapy

Intervention Type: RADIATION

Undergo radiation

Cisplatin

Intervention Type: DRUG

Given IV

Internal Radiation Therapy

Intervention Type: RADIATION

Undergo radiation

Arm II

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

Group Type: EXPERIMENTAL

External Beam Radiation Therapy

Intervention Type: RADIATION

Undergo radiation

Cisplatin

Intervention Type: DRUG

Given IV

Internal Radiation Therapy

Intervention Type: RADIATION

Undergo radiation

Epoetin Alfa

Intervention Type: BIOLOGICAL

Given SC

Interventions

External Beam Radiation Therapy

Undergo radiation

Intervention Type: RADIATION

Cisplatin

Given IV

Intervention Type: DRUG

Internal Radiation Therapy

Undergo radiation

Intervention Type: RADIATION

Epoetin Alfa

Given SC

Intervention Type: BIOLOGICAL

Other Intervention Names

Definitive Radiation Therapy; EBRT; External Beam RT; Brachytherapy; Internal Radiation; Internal Radiation Brachytherapy; Radiation Brachytherapy; EPO; Epogen; Eprex; erythropoietin; r-HuEPO

Eligibility Criteria

Inclusion Criteria

• 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
• Performance status - GOG 0-3
• See Disease Characteristics
• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Bilirubin no greater than 1.5 times normal
• SGOT no greater than 3 times normal
• Alkaline phosphatase no greater than 3 times normal
• Creatinine no greater than 2.0 mg/dL
• No uncontrolled hypertension
• No history of thrombotic vascular events (e.g., deep vein thrombosis or myocardial infarction)
• No active hemolysis
• No history of pulmonary embolism
• 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 B_12 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
• See Disease Characteristics
• See Disease Characteristics

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Canadian Cancer Trials Group

NETWORK

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Gynecologic Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gillian Thomas

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

Gynecologic Oncology Group of Arizona

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

NCI-2012-02384

Identifier Type: REGISTRY

Identifier Source: secondary_id

CAN-NCIC-CX4

Identifier Type: -

Identifier Source: secondary_id

CDR0000068641

Identifier Type: -

Identifier Source: secondary_id

GOG-0191

Identifier Type: OTHER

Identifier Source: secondary_id

GOG-0191

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA027469

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GOG-0191

Identifier Type: -

Identifier Source: org_study_id