Reducing Salivary Toxicity with Adaptive Radiotherapy : A Randomized Controlled trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- 1.Salivary toxicity at 12 months post radiation: The acute salivary toxicity will be assessed with salivary scintigraphy. The salivary function at 12 months will be determined by the ratio of SEF at 12 months after treatment compared to the baseline SEF (pre-treatment) x 100%.
研究概览
简要总结
IMRT is widely accepted as the standard treatment for head and neck cancers. As dose application becomes more precise, various factors may lead to a deviation in the intended radiation dose delivery like daily setup variations and geometric and volumetric changes during the course of RT. This inaccuracy may lead to either under dosage of the target volume with resultant risk of tumour recurrence or over dosage of the normal tissues leading potential risk of increased complications. This has led to the development of an adaptive radiation scheme with periodic adjustment of the treatment plan that takes into account such treatment-related anatomic changes and protects parotid glands from an overdose of irradiation.Hence this study is planned to assess the efficacy of adaptive radiotherapy in reducing salivary toxicity in head and neck cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Biopsy proven Squamous cell carcinoma of the oropharynx, hypopharynx and larynx.
- •2.AJCC stage T1-3, N0-2c, M
- •4.Age ≥18 and ≤ 70 years.
- •5.Patient willing and reliable for follow-up.
- •6.Patient’s nutritional & physical condition compatible with planned therapy.
- •7.Signed study specific consent form.
排除标准
- •1.T1-2 N0 M0 of Vocal cords 2.History of surgery for the primary or node in head and neck.
- •3.Evidence of distant metastases or N3 nodal stage.
- •4.Previous therapeutic irradiation for head & neck cancer.
- •5.Patients who have received neoadjuvant chemotherapy.
- •6.Active untreated infection, which preclude the use of systemic chemotherapy or would interfere with completion of treatment.
- •8.Primary nasopharyngeal or paranasal sinus cancers.
- •9.Pregnancy or lactating women.
- •10.Previous history of malignancy within 5 years.
结局指标
主要结局
1.Salivary toxicity at 12 months post radiation: The acute salivary toxicity will be assessed with salivary scintigraphy. The salivary function at 12 months will be determined by the ratio of SEF at 12 months after treatment compared to the baseline SEF (pre-treatment) x 100%.
时间窗: 1 year
次要结局
- 1.To assess the acute and late normal tissue toxicity.(2.To compare the loco-regional control.)