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
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Condition or disease | Intervention/treatment | Phase |
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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 |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 114 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | August 2001 |
Actual Primary Completion Date : | May 15, 2004 |

Arm | Intervention/treatment |
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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.
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Radiation: External Beam Radiation Therapy
Undergo radiation
Other Names:
Drug: Cisplatin Given IV Radiation: Internal Radiation Therapy Undergo radiation
Other Names:
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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.
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Radiation: External Beam Radiation Therapy
Undergo radiation
Other Names:
Drug: Cisplatin Given IV Radiation: Internal Radiation Therapy Undergo radiation
Other Names:
Biological: Epoetin Alfa Given SC
Other Names:
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- 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 ]
- 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 ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00017004
United States, Arizona | |
Gynecologic Oncology Group of Arizona | |
Phoenix, Arizona, United States, 85012 |
Principal Investigator: | Gillian Thomas | Gynecologic Oncology Group |
Responsible Party: | Gynecologic Oncology Group |
ClinicalTrials.gov Identifier: | NCT00017004 History of Changes |
Other Study ID Numbers: |
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 ) |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | August 9, 2017 |
Last Verified: | August 2017 |
Carcinoma Adenocarcinoma Uterine Cervical Neoplasms Carcinoma, Adenosquamous Anemia Drug-Related Side Effects and Adverse Reactions Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms 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 |