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Epoetin Beta in Treating Anemia in Patients With Cervical Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00046969
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 30, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Epoetin beta may stimulate red blood cell production to prevent or control anemia in patients treated with chemotherapy and radiation therapy.

PURPOSE: Randomized phase IV trial to determine the effectiveness of epoetin beta in treating anemia in patients who are receiving cisplatin and radiation therapy for stage IIB, stage III, or stage IVA cervical cancer.

Condition or disease Intervention/treatment Phase
Anemia Cervical Cancer Biological: epoetin beta Drug: cisplatin Radiation: brachytherapy Radiation: radiation therapy Phase 4

Detailed Description:


  • Compare the effectiveness of epoetin beta vs standard care for anemia management, in terms of increased hemoglobin levels and the correlation with reduced relapse/treatment failure rate, in patients with stage IIB, III, or IVA cervical cancer treated with cisplatin and radiotherapy.
  • Compare the safety of these regimens in these patients.
  • Compare the relapse-free and overall survival of patients treated with these regimens.
  • Compare the frequency and localization of relapses and metastases in patients treated with these regimens.
  • Compare the quality of life of patients treated with these regimens.
  • Compare the type, frequency, and degree of adverse events in patients treated with these regimens.
  • Compare the overall response rate in patients treated with these regimens.

OUTLINE: This is a randomized, open-label, parallel-group, multicenter study. Patients are stratified according to country, disease stage, and brachytherapy technique. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo radiotherapy 5 days a week for 6 weeks. Patients also undergo high-dose rate, low-dose rate, or boost brachytherapy. Patients receive cisplatin IV beginning on day 1 of radiotherapy and continuing weekly for 6 weeks. Patients also receive epoetin beta subcutaneously 3 times a week beginning 2 weeks before radiotherapy and continuing for 8 weeks.
  • Arm II: Patients undergo radiotherapy and brachytherapy and receive cisplatin as in arm I.

Quality of life is assessed at baseline, after the last treatment, and at 3 months.

Patients are followed every 3 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 80-450 patients will be accrued for this study within 4-22.5 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Management Of Anemia Under RadioChemotherapy (MARCH): An Open, Randomized Multicenter Study Of The Effect Of NeoRecormon On Treatment Outcome In Patients With Advanced Cervical Cancer Stage IIB -IVA Treated With Primary Simultaneous Radiochemotherapy (Radiotherapy Plus Cisplatin)
Study Start Date : July 2002
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Primary Outcome Measures :
  1. Number of treatment failures within 6 months after beginning radiochemotherapy (RCT) (stage I)
  2. Overall survival after RCT (stage II)

Secondary Outcome Measures :
  1. Progression/relapse-free survival
  2. Overall response rate to RCT
  3. Overall survival after RCT (stage I)
  4. Frequency and localization of relapses and/or metastases
  5. Change in hemoglobin from baseline during therapy
  6. Quality of life as assessed by the Functional Assessment of Cancer Therapy-Anemia
  7. Type, frequency, and degree of adverse events
  8. Safety
  9. Vital signs
  10. Number of treatment failures within 6 months after beginning RCT (stage II)

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed stage IIB, III, or IVA cervical cancer

    • No chorion carcinoma or neuroendocrine small cell carcinoma
    • Previously untreated disease
  • Must be scheduled to undergo radiotherapy and receive cisplatin as primary therapy
  • Hemoglobin 8.0-13.0 g/dL
  • No relevant acute bleeding within the past 3 months, including anemia caused by gross bleeding from tumor
  • No distant metastasis
  • No positive para-aortic lymph nodes



  • Over 18

Performance status

  • WHO 0-2

Life expectancy

  • At least 3 months


  • See Disease Characteristics
  • WBC greater than 3,000/mm3
  • Platelet count greater than 100,000/mm3
  • No hemolytic anemia
  • No transferrin saturation less than 20% that cannot be treated with IV iron
  • No hemoglobinopathies (i.e., sickle cell disease or thalassemia of all types)


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • Transaminases no greater than 2.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN


  • Creatinine clearance greater than 60 mL/min


  • No chronic heart failure
  • No New York Heart Association class II-IV heart disease
  • No uncontrolled arterial hypertension (systolic blood pressure at least 170 mmHg, diastolic blood pressure at least 100 mmHg)
  • No prior deep vein thrombosis
  • No thrombocytosis


  • No vitamin B12 deficiency
  • No folic acid deficiency
  • No newly diagnosed (unstable) epilepsy
  • No acute infection
  • No other malignancy within the past 5 years except basal cell carcinoma in situ
  • No known peripheral neuropathy or moto-sensory neurotoxicity grade 2 or greater
  • No impaired hearing grade 2 or greater
  • No hypersensitivity to benzyl alcohol, benzoic acid, benzalkonium chloride, or any excipients of cisplatin preparations
  • Not pregnant or nursing


Biologic therapy

  • At least 3 months since prior epoetins or related compounds


  • See Disease Characteristics

Endocrine therapy

  • Not specified


  • See Disease Characteristics
  • No prior radiotherapy for cervical cancer


  • Not specified


  • At least 30 days since prior investigational drugs
  • No prior systemic antineoplastic therapy for cervical cancer
  • No other concurrent investigational drugs

Information from the National Library of Medicine

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 identifier (NCT number): NCT00046969

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Martin Luther Universitaet
Halle, Germany, D-06097
Sponsors and Collaborators
AGO Study Group
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Study Chair: Heinz Koelbl, MD Martin-Luther-Universität Halle-Wittenberg
Layout table for additonal information Identifier: NCT00046969    
Other Study ID Numbers: AGOSG-OVAR-MO16375-MARCH
CDR0000257189 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: March 2007
Keywords provided by National Cancer Institute (NCI):
stage IIB cervical cancer
stage III cervical cancer
stage IVA cervical cancer
cervical adenosquamous cell carcinoma
cervical squamous cell carcinoma
cervical adenocarcinoma
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Hematologic Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Antineoplastic Agents