Phase II Study of 3-Dimensional Conformal Radiotherapy (3D-CRT) vs Intensity Modulated Radiotherapy (IMRT) for Squamous Cell Carcinoma of the Head and Neck (HNSCC)
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Major salivary gland sparing by 3-D CRT vis-à-vis IMRT. Assess adequacy of target volume coverage
研究概览
简要总结
Head & Neck squamous cell carcinomas are the commonest cancers afflicting the developing countries. Traditionally surgery or radiotherapy alone in the early stages and surgery with postoperative radiotherapy in advanced stages have been the mainstay of treatment. Of late there has been a paradigm shift in the management of these cancers, particularly those of the oropharynx and laryngopharynx, where chemoradiation has been advocated as part of organ preservation protocol with good outcomes. Conventional radiotherapy involves the use of 2 or 3 field technique with or without compensators to encompass the volume at risk to radical doses of 66-70 Gy typically needed to sterilize gross disease. This strategy however is associated with considerable acute morbidity (mucositis, dysphagia, dermatitis) and debilitating late toxicity (xerostomia). Three dimensional conformal radiation therapy (3D-CRT) and intensity modulated radiation therapy (IMRT) have the potential to improve the dose distribution, with increased doses to the target volumes and reduced doses to surrounding normal structures, thereby improving the therapeutic ratio.
详细描述
1.0 Introduction: Head & Neck squamous cell carcinomas are the commonest cancers afflicting the developing countries. Traditionally surgery or radiotherapy alone in the early stages and surgery with postoperative radiotherapy in advanced stages have been the mainstay of treatment. Of late there has been a paradigm shift in the management of these cancers, particularly those of the oropharynx and laryngopharynx, where chemoradiation has been advocated as part of organ preservation protocol with good outcomes. Conventional radiotherapy involves the use of 2 or 3 field technique with or without compensators to encompass the volume at risk to radical doses of 66-70 Gy typically needed to sterilize gross disease. This strategy however is associated with considerable acute morbidity (mucositis, dysphagia, dermatitis) and debilitating late toxicity (xerostomia). Three dimensional conformal radiation therapy (3D-CRT) and intensity modulated radiation therapy (IMRT) have the potential to improve the dose distribution, with increased doses to the target volumes and reduced doses to surrounding normal structures, thereby improving the therapeutic ratio.
2.0 Objectives: 2.1 To compare the major salivary gland sparing by 3-D CRT vis-à-vis IMRT and assess the adequacy of target volume coverage with these conformal techniques.
2.2 To determine the pattern of local and loco-regional recurrence. 2.3 To determine Disease Free Survival (DFS) & Overall Survival (OAS) 2.4 To study the quality of life of these patients 2.5 To assess the reduction in dose with IMRT to the normal larynx & normal pharyngeal constrictors in oropharyngeal cancers, uninvolved oral mucosa and middle & inner ear apparatus in both oropharyngeal & laryngopharyngeal cancers
3.0 Patient Selection: 3.1 Eligibility 3.1.1 Biopsy proven squamous cell carcinoma of the oropharynx or laryngopharynx.
3.1.2. AJCC stage T1-3, NO-2b, MO patients with pre-treatment tumor measurements clinically as well as on CT/MRI scans. 3.1.3 Surgery of the primary tumor limited to excisional or incisional biopsy. 3.1.4 No form of neck dissection for nodal metastases. 3.1.5 KPS > 60 (see appendix I). 3.1.6 Age > 18 and < 65 years. 3.1.7 No prior history of therapeutic irradiation. 3.1.8 Patient willing and reliable for follow-up. 3.1.9 Patient's nutritional & physical condition compatible with planned therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven squamous cell carcinoma of the oropharynx or laryngopharynx.
- •AJCC stage T1-3, NO-2b, MO patients with pre-treatment tumor measurements clinically as well as on CT/MRI scans.
- •Surgery of the primary tumor limited to excisional or incisional biopsy.
- •No form of neck dissection for nodal metastases.
- •KPS > 60 (see appendix I).
- •Age > 18 and < 65 years.
- •No prior history of therapeutic irradiation.
- •Patient willing and reliable for follow-up.
- •Patient's nutritional & physical condition compatible with planned therapy.
排除标准
- •Evidence of distant metastases.
- •Previous therapeutic irradiation for head & neck cancer or any other invasive cancer other than squamous or basal cell carcinoma of the skin.
- •History of prior malignancy.
- •Prophylactic use of amifostine or pilocarpine.
- •Active untreated infection like tuberculosis, which preclude the use of systemic chemotherapy or would interfere with completion of treatment.
- •Any histopathology other than Squamous Carcinoma.
- •Primary nasopharyngeal carcinoma.
- •Age < 18 or > 65 years.
- •Pregnancy or lactating women.
结局指标
主要结局
Major salivary gland sparing by 3-D CRT vis-à-vis IMRT. Assess adequacy of target volume coverage
时间窗: 4 yrs
Determine the pattern of local and loco-regional recurrence
时间窗: 4 yrs
次要结局
- Disease Free Survival (DFS) and Overall Survival (OAS)(4 yrs)
- Quality of life 3. Dose to OAR(4 yrs)
- Assess the reduction in dose with IMRT to the normal larynx and normal pharyngeal constrictors in oropharyngeal cancers, uninvolved oral mucosa and auditory apparatus(4 yrs)