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

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ClinicalTrials.gov Identifier: NCT00017004
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 9, 2017
Sponsor:
Collaborators:
Canadian Cancer Trials Group
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

Tracking Information
First Submitted Date  ICMJE June 6, 2001
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date August 9, 2017
Study Start Date  ICMJE August 2001
Actual Primary Completion Date May 15, 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2014)
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 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00017004 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2014)
  • Overall survival [ Time Frame: Up to 5 years ]
  • Local control, coded as successful if any relapse or disease progression is is contained within the pelvic field [ Time Frame: Up to 5 years ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiation Therapy and Cisplatin With or Without Epoetin Alfa in Treating Patients With Cervical Cancer and Anemia
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • 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
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Radiation: External Beam Radiation Therapy
    • Drug: Cisplatin
    • Radiation: Internal Radiation Therapy
  • 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.
    Interventions:
    • Radiation: External Beam Radiation Therapy
    • Drug: Cisplatin
    • Radiation: Internal Radiation Therapy
    • Biological: Epoetin Alfa
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2014)
114
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 15, 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Canada,   Norway,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT00017004
Other Study ID Numbers  ICMJE GOG-0191
NCI-2012-02384 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CAN-NCIC-CX4
CDR0000068641
GOG-0191 ( Other Identifier: Gynecologic Oncology Group )
GOG-0191 ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gynecologic Oncology Group
Study Sponsor  ICMJE Gynecologic Oncology Group
Collaborators  ICMJE
  • Canadian Cancer Trials Group
  • National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Gillian Thomas Gynecologic Oncology Group
PRS Account Gynecologic Oncology Group
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP