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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
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00017004
First received: June 6, 2001
Last updated: February 12, 2014
Last verified: February 2014

June 6, 2001
February 12, 2014
August 2001
November 2003   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00017004 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
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Radiation Therapy and Cisplatin With or Without Epoetin Alfa in Treating Patients With Cervical Cancer and Anemia
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Anemia
  • Cervical Adenocarcinoma
  • Cervical Adenosquamous Cell Carcinoma
  • Cervical Squamous Cell Carcinoma
  • Drug/Agent Toxicity by Tissue/Organ
  • Radiation Toxicity
  • Stage IIB Cervical Cancer
  • Stage III Cervical Cancer
  • Stage IVA Cervical Cancer
  • Biological: amifostine/epoetin alfa
    Given SC
  • Drug: 17-N-allylamino-17-demethoxygeldanamycin/cisplatin
    Given IV
  • Radiation: brachytherapy
    Undergo radiation
    Other Names:
    • low-LET implant therapy
    • radiation brachytherapy
    • therapy, low-LET implant
  • Radiation: 3-dimensional conformal radiation therapy
    Undergo radiation
    Other Names:
    • 3D conformal radiation therapy
    • 3D-CRT
  • 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:
    • Drug: 17-N-allylamino-17-demethoxygeldanamycin/cisplatin
    • Radiation: brachytherapy
    • Radiation: 3-dimensional conformal 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:
    • Biological: amifostine/epoetin alfa
    • Drug: 17-N-allylamino-17-demethoxygeldanamycin/cisplatin
    • Radiation: brachytherapy
    • Radiation: 3-dimensional conformal radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
114
Not Provided
November 2003   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00017004
GOG-0191, NCI-2012-02384, CAN-NCIC-CX4, CDR0000068641, GOG-0191, GOG-0191, U10CA027469
Not Provided
Gynecologic Oncology Group
Gynecologic Oncology Group
  • NCIC Clinical Trials Group
  • National Cancer Institute (NCI)
Principal Investigator: Gillian Thomas Gynecologic Oncology Group
Gynecologic Oncology Group
February 2014

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