Conventionally fractionated versus accelerated postoperative radiotherapy in squamous cell carcinoma of the head and neck (SCCHC): a phase III randomised study

Vrije University Medical Centre (VUMC) (Netherlands)0 个研究点目标入组 350 人开始时间: 2005年12月20日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Proper clinical evaluation must have been performed according to the national guidelines
•2. Histologically proven squamous cell carcinoma (World Health Organisation [WHO] grade 1 - 3) of the oral cavity, oropharynx, hypopharynx or larynx (unknown primary excluded)
•3. Primary surgery with curative intent
•4. High risk for loco-regional recurrence, i.e. positive resection margins (less than 1 mm) and/or lymph node metastases with extranodal spread
•5. Radiotherapy must start preferentially within 6 weeks but not later than 7 weeks after surgery
•6. Previously untreated patients (except the surgery)
•7. Age greater than 18 years, either sex
•8. WHO performance status 0 - 2
•9. Patients of reproductive potential must agree to practice an effective contraceptive method
•10. Written informed consent

•1. Macroscopic residual disease at the primary site and/or neck
•2. Distant metastases
•3. Previous malignancy except basal cell carcinoma of the skin or in situ carcinoma of the cervix or superficial bladder cancer (pTa)
•4. Previous induction chemotherapy, concurrent or adjuvant chemotherapy
•5. Pregnant or lactating
•6. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

发起方

Vrije University Medical Centre (VUMC) (Netherlands)