NCT00046969已完成4 期
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)
AGO Study Group2 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2002年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Number of treatment failures within 6 months after beginning radiochemotherapy (RCT) (stage I)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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:
- •Performance status
- •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)
- •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
- •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
- •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
- •Not specified
- 另有 3 项未显示
排除标准
- 未提供
结局指标
主要结局
Number of treatment failures within 6 months after beginning radiochemotherapy (RCT) (stage I)
Overall survival after RCT (stage II)
次要结局
- Progression/relapse-free survival
- Overall response rate to RCT
- Overall survival after RCT (stage I)
- Frequency and localization of relapses and/or metastases
- Change in hemoglobin from baseline during therapy
- Quality of life as assessed by the Functional Assessment of Cancer Therapy-Anemia
- Type, frequency, and degree of adverse events
- Safety
- Vital signs
- Number of treatment failures within 6 months after beginning RCT (stage II)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Erythropoietin for Management of Anemia Caused by ChemotherapyDiffuse Large B-cell LymphomaNCT02890602Kosin University Gospel Hospital53
已完成
2 期
Epoetin Alfa in Treating Patients With Anemia Who Are Undergoing Chemotherapy for CancerLymphoproliferative DisorderMultiple Myeloma and Plasma Cell NeoplasmPrecancerous ConditionUnspecified Adult Solid Tumor, Protocol SpecificLeukemiaAnemiaLymphomaNCT00255749Jonsson Comprehensive Cancer Center89
已完成
3 期
Epoetin Alfa in Treating Anemia in Patients Who Are Receiving ChemotherapyChronic Myeloproliferative DisordersDrug/Agent Toxicity by Tissue/OrganBreast CancerAnemiaMultiple Myeloma and Plasma Cell NeoplasmPrecancerous ConditionSmall Intestine CancerUnspecified Adult Solid Tumor, Protocol SpecificLung CancerLeukemiaLymphomaNCT00003600Alliance for Clinical Trials in Oncology344
已完成
3 期
Epoetin Alfa in Treating Anemia in Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma and Anemia Caused By ChemotherapyMultiple Myeloma and Plasma Cell NeoplasmLeukemiaAnemiaLymphomaNCT00003341Memorial Sloan Kettering Cancer Center275
已完成
3 期
Anemia in Patients With a Non-Myeloid MalignancyNeoplasmsAnemiaNCT00038064Amgen707