Prospective trial to evaluate acute toxicity during post operative radiotherapy after flap reconstructive surgery in head and neck cancer patients undergoing volumetric modulated ARC therapy
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1.To evaluate acute toxicity (mucositis, dysphagia, dermatitis, xerostomia, dysgeusia, anorexia, nausea, vomiting, pain) of postoperative radiotherapy between SIB- VMAT and non SIB- VMAT treatment technique during treatment and at 3 months follow up.
研究概览
简要总结
The current practice of Post operative radiotherapy in Head and Neck cancer involves radiation of the entire flap in treatment portal. This leads to a considerable increase in radiotherapy treatment volume. As a consequence, there is significant acute toxicity associated with treatment and associated flap changes. Recent literature and guidelines have recommended to include only the flap junctional area in high-risk treatment volume. The rest of flap can be included in the low dose radiotherapy treatment volume.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 16.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Biopsy proven Squamous cell carcinoma of oral cavity and paranasal sinus.
- •2.Adult patients undergoing surgery with flap reconstruction and post operative radiotherapy.
- •3.Patients requiring post operative radiotherapy for any of the following indications: T3N0M0, T1-3N1,2M0, T4aN2M0, AnyTN3M0 disease.
- •4.Patient requiring postoperative radiotherapy due to positive margin, close margin, extra nodal extension in Post Operative Histopathology Report.
- •Patients giving written consent for study and follow up.
排除标准
- •1.Patient being treated for recurrent head and neck cancer.
- •2.Patient with uncontrolled comorbidities like diabetes mellitus and hypertension.
- •3.Previous history of undergoing head and neck radiotherapy.
结局指标
主要结局
1.To evaluate acute toxicity (mucositis, dysphagia, dermatitis, xerostomia, dysgeusia, anorexia, nausea, vomiting, pain) of postoperative radiotherapy between SIB- VMAT and non SIB- VMAT treatment technique during treatment and at 3 months follow up.
时间窗: 1.During treatment | 2. At 3 months follow up.
次要结局
- To evaluate incidence of flap complications- infection, mild dehiscence, bone exposure, fistula, hematoma, partial flap loss, complete flap loss)between SIB- VMAT and non SIB- VMAT treatment technique during treatment and at 3 months follow up.(2. To evaluate disease recurrence between the study groups at a minimum of three months follow up.)
研究者
PROF AMIT BAHL
PGIMER, CHANDIGARH