Clinical trial · Interventional
Epoetin Beta in Treating Anemia in Patients With Cervical Cancer
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| brachytherapy | Radiation | — | UNRESOLVED |
| cisplatin | Drug | Cisplatin | ALIAS |
| epoetin beta | Biological | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Number of treatment failures within 6 months after beginning radiochemotherapy (RCT) (stage I)
- measure
- Overall survival after RCT (stage II)
Secondary outcomes (10)
- measure
- Progression/relapse-free survival
- measure
- Overall response rate to RCT
- measure
- Overall survival after RCT (stage I)
- measure
- Frequency and localization of relapses and/or metastases
- measure
- Change in hemoglobin from baseline during therapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available