NCT00004256已完成2 期
Randomised Phase II Study of GM-CSF to Reduce Severity of Mucositis Caused by Accelerated Radiotherapy of Laryngeal Cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as sargramostim may protect normal cells from the side effects of radiation therapy.
PURPOSE: Randomized phase II trial to determine the effectiveness of sargramostim in preventing mucositis in patients who are receiving radiation therapy for laryngeal cancer.
详细描述
OBJECTIVES:
- Determine the efficacy of sargramostim (GM-CSF) in reducing the duration and severity of mucositis resulting from accelerated radiotherapy in patients with laryngeal carcinoma.
- Determine the effect of GM-CSF on quality of life aspects of these patients as assessed by nutritional status, analgesic use, and days in the hospital.
OUTLINE: This is a randomized study.
Patients receive radiotherapy in 16 fractions over 21 days. Patients are randomly allocated to one of two treatment arms before scheduled radiotherapy begins.
- Arm I: Patients receive sargramostim (GM-CSF) SC daily for 14 days beginning on day 14 of the course of radiotherapy.
- Arm II: Patients do not receive GM-CSF. Patients are followed weekly until mucositis is healed, as well as at weeks 2 and 6 following the end of radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of laryngeal cancer with intention to treat by radiotherapy using a 16 fraction 3 week scheme
- •Stage I or II
- •No known CNS disease
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Hepatic function normal
- •Renal function normal
- •Not pregnant or nursing
- •No serious active infection requiring antibiotic therapy
- •No autoimmune disease
- •No known seizures
- •No psychosocial factors that would preclude study compliance
- •No allergies to sargramostim (GM-CSF)
- •Willingness to cooperate for regular mirror examination of the larynx
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent immunotherapy
- •Chemotherapy:
- •No concurrent chemotherapy
- •Endocrine therapy:
- •No prior or concurrent corticosteroids
- •No concurrent hormonal therapy
- •Radiotherapy:
- •See Disease Characteristics
- •No major organ allografts
- •No other concurrent investigational drugs
排除标准
- 未提供
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade GliomaBrain and Central Nervous System TumorsNCT00003375Radiation Therapy Oncology Group370
已完成
2 期
Radiation Therapy, Temozolomide, and Irinotecan in Treating Patients With Newly Diagnosed Glioblastoma MultiformeBrain and Central Nervous System TumorsNCT00099125Radiation Therapy Oncology Group170
Unknown
2 期
Celecoxib or Observation After Radiation Therapy and Chemotherapy in Treating Patients With Stage II or Stage III Non-Small Cell Lung CancerLung CancerNCT00274898GERCOR - Multidisciplinary Oncology Cooperative Group80
已完成
2 期
Radiation Therapy in Treating Patients With Extensive Stage Small Cell Lung CancerLung CancerNCT01055197Radiation Therapy Oncology Group97
已完成
3 期
Radiation Therapy Plus Combination Chemotherapy in Treating Children With MedulloblastomaCentral Nervous System TumorsBrain TumorsNCT00002875Children's Oncology Group421