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

This study has been completed.
Sponsor:
Collaborators:
NCIC Clinical Trials Group
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00017004
First received: June 6, 2001
Last updated: December 29, 2014
Last verified: December 2014
History of Changes
  Purpose
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.

Condition Intervention Phase
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
 Radiation: External Beam Radiation Therapy
Drug: Cisplatin
Radiation: Internal Radiation Therapy
Biological: Epoetin Alfa
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Progression-free survival with progression defined as a 50% or greater increase in the cross-product of the existing primary tumor relative to the smallest cross-product from all previous exams [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Local control, coded as successful if any relapse or disease progression is is contained within the pelvic field [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
Enrollment: 114
Study Start Date: August 2001
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 Radiation: External Beam Radiation Therapy
Undergo radiation
Other Names:
  • Definitive Radiation Therapy
  • EBRT
  • External Beam RT
Drug: Cisplatin
Given IV
Radiation: Internal Radiation Therapy
Undergo radiation
Other Names:
  • Brachytherapy
  • Internal Radiation
  • Internal Radiation Brachytherapy
  • Radiation Brachytherapy
Experimental: Arm II
Patients undergo radiotherapy and chemotherapy as in arm I. Additionally, patients receive epoetin alfa subcutaneously once weekly concurrently with radiotherapy and chemotherapy.
 Radiation: External Beam Radiation Therapy
Undergo radiation
Other Names:
  • Definitive Radiation Therapy
  • EBRT
  • External Beam RT
Drug: Cisplatin
Given IV
Radiation: Internal Radiation Therapy
Undergo radiation
Other Names:
  • Brachytherapy
  • Internal Radiation
  • Internal Radiation Brachytherapy
  • Radiation Brachytherapy
Biological: Epoetin Alfa
Given SC
Other Names:
  • EPO
  • Epogen
  • Eprex
  • erythropoietin
  • r-HuEPO

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.

  Eligibility
Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00017004

Locations
United States, Arizona
Gynecologic Oncology Group of Arizona
Phoenix, Arizona, United States, 85012
Sponsors and Collaborators
Gynecologic Oncology Group
NCIC Clinical Trials Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Gillian Thomas Gynecologic Oncology Group
  More Information

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00017004     History of Changes
Other Study ID Numbers: GOG-0191  NCI-2012-02384  CAN-NCIC-CX4  CDR0000068641  GOG-0191  GOG-0191  U10CA027469 
Study First Received: June 6, 2001
Last Updated: December 29, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Adenocarcinoma
Anemia
Uterine Cervical Neoplasms
Carcinoma, Adenosquamous
Drug-Related Side Effects and Adverse Reactions
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Hematologic Diseases
Uterine Neoplasms
 Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Chemically-Induced Disorders
Cisplatin
Epoetin Alfa
Antineoplastic Agents
Hematinics

ClinicalTrials.gov processed this record on September 30, 2016