Induction chemotherapy and dysphagia optimized intensity modulated radiotherapy (DO- IMRT): An integrated approach for management of Pharyngeal Tumours- IC-DARS
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- To determine, if using induction chemotherapy and dysphagia optimized IMRT (DO-IMRT) to reduce the radiation dose delivered to the dysphagia/aspiration related structures (DARS), improves swallowing function in patients with head and neck cancer treated with radical radiotherapy or chemoradiation.
研究概览
简要总结
The study is Phase 3 randomized controlled open label trial with the hypothesis that While treating patients of pharyngeal tumors with definitive CTRT, if induction chemotherapy is being given, it will lead to decrease in tumor volume which will further lead to better sparing of DARS (Dysphagia and aspiration related structures) while planning Radiotherapy to the site. It will result in good QOL of the patients and eventually will lead to good survival outcome. With this hypothesis, appropriate sample size will be recruited after putting in inclusion and exclusion criteria. Comparator arm will be offered standard chemoradiotherapy with IMRT technique while intervention group will be offered induction chemotherapy followed by Dysphagia optimized intensity modulated radiotherapy. During RT, weekly assessment will be done and post RT completion, monthly then 3 monthly assessment will be done. Primary objective is to assess effect of induction chemotherapy and DO-IMRT to reduce radiation dose to dysphagia related structures result in improved quality of life and thereafter improved survival. Secondary objectives are local recurrence rate, locoregional recurrence rate, distant metastasis free survival, association with HPV status, overall survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Aged 18 years or above
- •Any patient undergoing radiotherapy for head and neck cancer in the oropharynx or hypopharynx.
- •3.Patients with tumor at other sites where the radical radiotherapy dose is to be delivered to the pharyngeal constrictors may also be eligible 4.Stage T1-4,N03,M0 disease;
- •this will be mostly histologically confirmed squamous cell carcinoma (SCC) but other histological types may be eligible.
- •Radiotherapy with concomitant chemotherapy (unless contra-indicated) is the planned treatment 7.WHO performance status 0 or 1
- •Must be available to attend long term follow up 9.Adequate cognitive ability to complete the questionnaires
- •Written informed consent.
排除标准
- •1.Documented evidence of pre-existing swallowing dysfunction (not related to head and neck cancer).
- •2.Previous radiotherapy to the head and neck region.
- •3.Any contra-indication to Chemotherapy/Radiotherapy 4.Posterior pharyngeal wall, post cricoid or retropharyngeal lymph node involvement.
- •5.Lateralized tumors, requiring unilateral neck irradiation.
- •6.Major head and neck surgery (excluding biopsies/tonsillectomy).
- •7.Current/previous tracheostomy placement.
- •8.Previous or concurrent illness, which in the investigator’s opinion would interfere with completion of therapy, trial assessments or follow up.
- •9.Any invasive malignancy within previous 2 years (other than non-melanomatous skin carcinoma or cervical carcinoma in situ).
结局指标
主要结局
To determine, if using induction chemotherapy and dysphagia optimized IMRT (DO-IMRT) to reduce the radiation dose delivered to the dysphagia/aspiration related structures (DARS), improves swallowing function in patients with head and neck cancer treated with radical radiotherapy or chemoradiation.
时间窗: weekly assessment during RT delievery and thereafter 0,1,3,6 months post RT completion
次要结局
- Local recurrence rate(Locoregional recurrence rate (LRR))
研究者
Dr Atul Kumar Gupta
AIIMS Jodhpur