NCT00004226Unknown1 期
Phase I/II Study of High Dose Limited Volume Postoperative Reirradiation in Recurrent or Second Primary Carcinoma of the Head and Neck
适应症
试验速览
- 阶段
- 1 期
- 试验地点
- 3
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy following surgery in treating patients who have recurrent or second primary cancer of the head and neck following previous radiation therapy.
详细描述
OBJECTIVES:
- Determine the survival and local control in previously irradiated patients at high risk for local failure following regional resection of recurrent or second primary head and neck cancer.
- Determine the acute and late toxicities of this treatment in these patients.
- Determine the pattern of disease failure in these patients on this treatment.
- Determine any change in quality of life in these patients on this treatment.
OUTLINE: Patients receive fractionated doses of radiotherapy five times weekly for 6 weeks.
Quality of life is assessed prior to study, 2 months after radiotherapy, every 3 months for remainder of year 1, every 4 months for years 2-3, every 6 months for years 4-5, and then annually thereafter.
Patients are followed 2 months after radiotherapy, every 3 months for year 1, every 4 months for year 2, every 6 months for years 3-5, and then annually thereafter.
研究设计
- 研究类型
- Interventional
- 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 squamous cell carcinoma of the mucosa, recurrent (primary and/or nodal), or a second primary (positive or negative nodal), of one of the following:
- •Oral cavity
- •Oropharynx
- •Hypopharynx
- •Paranasal sinus
- •Neck disease of unknown origin
- •No distant metastases
- •No primary in the nasopharynx
- •Must have complete gross resection of disease
- •Must have positive final margins, soft tissue extension of primary, positive extracapsular extension of lymph node disease, or at least 4 positive nodes without extracapsular extension
- •Reirradiation field must overlap the previous field for a minimum of 3 cm in height, width, and length
- •At least 6 months since prior radiotherapy with an overlap volume of at least 45 Gy
- •No grade 3 or 4 toxicity for the following organ tissues:
- •RTOG grade 3 or 4 skin, subcutaneous tissue, larynx, joint, or RTOG grade 4 mucous membrane or bone from prior radiotherapy
- •Radiotherapy must begin within 6-12 weeks of surgery
- •Prior radiotherapy records must be available
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •Not pregnant
- •No history of invasive malignancy that would be expected to cause death within 3 years
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- •See Disease Characteristics
排除标准
- 未提供
研究者
研究点 (3)
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