NCT00004917已完成3 期
A Randomized Phase III Trial to Assess the Effect of Erythropoietin on Local-Regional Control in Anemic Patients Treated With Radiotherapy for Carcinoma of the Head and Neck
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 261
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Epoetin alfa may stimulate red blood cell production and treat anemia in patients with head and neck cancer. It is not yet known whether receiving radiation therapy with epoetin alfa is more effective than radiation therapy alone in treating anemic patients with head and neck cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without epoetin alfa in treating anemic patients who have head and neck cancer.
详细描述
OBJECTIVES:
Primary
- Determine whether epoetin alfa given during definitive radiotherapy or chemoradiotherapy improves the local-regional control rate in anemic patients with squamous cell carcinoma of the head and neck.
Secondary
- Determine whether this drug improves survival in this patient population.
- Identify patterns in first failure in these patients.
- Determine whether there is a significant increase in hemoglobin level between the baseline value and the value at 28 days after starting epoetin alfa in these patients.
- Assess the toxicity of this regimen in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed invasive squamous cell carcinoma of the head and neck, including carcinoma arising from the oral cavity, oropharynx, larynx, and hypopharynx
- •Stage I-IV disease
- •No distant metastases
- •No carcinoma of the nasopharynx, nasal cavity/paranasal sinuses, or salivary glands
- •No carcinoma in situ without an identifiable invasive component
- •Plan for radiotherapy in continuous course
- •Prior surgical exploration with gross residual disease remaining allowed
- •Prior neck dissection with or without biopsy of primary tumor, but no radical surgery for primary tumor, allowed
- •Anemia, defined as hemoglobin no greater than 13.5 g/dL for males and no greater than 12.5 g/dL for females (transfusion prior to study allowed)
- •No severe anemia (i.e., hemoglobin less than 9.0 g/dL)
- •No anemia confirmed to be due to causes other than chronic disease (e.g., iron deficiency anemia)
- •Not entered on other RTOG head and neck protocols
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Zubrod 0-2
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •See Disease Characteristics
- •Stage III/IV patients receiving concurrent cisplatin:
- •Absolute neutrophil count at least 2,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Not specified
- •Stage III/IV patients receiving concurrent cisplatin:
- •Creatinine no greater than 1.5 mg/dL
- •Creatinine clearance at least 50 mL/min
- •Cardiovascular:
- •No malignant or poorly controlled hypertension (e.g., symptomatic hypertension or diastolic blood pressure of 100 mm Hg or greater despite antihypertensive medication)
- •No unstable angina or other poorly controlled cardiac disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •If stage III or IV disease is present, willing to come for twice daily radiotherapy for the last 2.5 weeks of therapy
- •No active infection requiring IV antibiotics
- •No unexplained fever
- •No AIDS or other history of congenital or acquired immunodeficiency
- •No other malignancies within the past 3 years except carcinoma in situ or nonmelanomatous skin cancer
- •No known hypersensitivity to mammalian cell-derived products or to human albumin
- •No acute/subacute illness that would make the need for transfusion likely
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since other prior cytokine therapy (e.g., filgrastim [G-CSF], interleukins, or interferons)
- •No prior epoetin alfa
- •No other concurrent cytokine therapy
- •Chemotherapy:
- •No prior chemotherapy
- •Concurrent cisplatin, paclitaxel/cisplatin, or paclitaxel/carboplatin for patients with stage III/IV disease is allowed
- •Endocrine therapy:
- 另有 7 项未显示
排除标准
- 未提供
研究者
研究点 (261)
Loading locations...
相似试验
终止
3 期
Radiation Therapy With or Without Epoetin Alfa in Treating Patients With Head and Neck CancerHead and Neck CancerNCT00017277European Organisation for Research and Treatment of Cancer - EORTC47
已完成
3 期
Interferon Alfa-2b With or Without Radiation Therapy in Treating Patients With Melanoma That Has Metastasized to Lymph Nodes in the Neck, Under the Arm, or in the GroinMelanoma (Skin)NCT00003444Eastern Cooperative Oncology Group167
已完成
3 期
Radiation Therapy Compared With Combination Chemotherapy in Treating Patients With Cancer of the UterusSarcomaNCT00002546Gynecologic Oncology Group216
已完成
3 期
Surgery With or Without Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Retroperitoneum or PelvisSarcomaNCT00091351Alliance for Clinical Trials in Oncology370
已完成
3 期
Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate CancerProstate CancerNCT00067015Memorial Sloan Kettering Cancer Center3