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)
18 Years
N/A
Female
Anemia, Cervical Cancer
Trial Information
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)
OBJECTIVES:
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- 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
PATIENT CHARACTERISTICS:
Age
- Over 18
Performance status
- WHO 0-2
Life expectancy
- At least 3 months
Hematopoietic
- 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)
Hepatic
- 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
Renal
- Creatinine clearance greater than 60 mL/min
Cardiovascular
- 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
Other
- 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
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 3 months since prior epoetins or related compounds
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- No prior radiotherapy for cervical cancer
Surgery
- Not specified
Other
- At least 30 days since prior investigational drugs
- No prior systemic antineoplastic therapy for cervical cancer
- No other concurrent investigational drugs
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Number of treatment failures within 6 months after beginning radiochemotherapy (RCT) (stage I)
Principal Investigator
Heinz Koelbl, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Martin-Luther-Universität Halle-Wittenberg
Authority:
United States: Federal Government
Study ID:
AGOSG-OVAR-MO16375-MARCH
NCT ID:
NCT00046969
Start Date:
July 2002
Completion Date:
June 2007
Related Keywords:
- Anemia
- Cervical Cancer
- anemia
- stage IIB cervical cancer
- stage III cervical cancer
- stage IVA cervical cancer
- cervical adenosquamous cell carcinoma
- cervical squamous cell carcinoma
- cervical adenocarcinoma
- Anemia
- Uterine Cervical Neoplasms
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