Prospective Study on Hypofractionated Intensity Modulated Radiation Therapy(using VMAT Technique) with Concurrent Chemotherapy in Locally Advanced Laryngeal and Hypopharyngeal Squamous Cell Cancers
试验速览
- 阶段
- 2/3 期
- 状态
- 进行中(未招募)
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Evaluation of loco-regional response.
研究概览
简要总结
Radiotherapy, in combination with chemotherapy is the mainstay of treatment for locally advanced laryngeal and hypopharyngeal cancers, as radical surgery is associated with high morbidity and functional compromise. The development of Intensity Modulated Radiation Therapy (IMRT) has resulted in improved dose distributions, with smaller volumes of normal tissues receiving high doses; which provides the opportunity of increasing the dose per fraction. Volumetric modulated arc therapy (VMAT) is a novel technique of delivering IMRT that reduces treatment delivery time and offers good conformity. Chemotherapy induced radio sensitization can also be considered as a method of biologic dose escalation. In this study, 44 patients will be selected based on their stage, general condition, other inclusion and exclusion criteria. The selected patients will be simulated by CT simulator. After CT simulation, contouring of the tumor and critical structures will be done. Patient will receive 55 Gy/20# to PTV 55, 50 Gy/20# to PTV 50 and 46 Gy/20# to PTV 46. Along with this, they will receive concurrent chemotherapy with injection cisplatin. First 3 follow-up visits will be at 2 weeks, 4 weeks and 6 weeks after completion of treatment. Thereafter, the follow up to continue monthly once for the first 6 months and at 3 monthly intervals for the rest of the study period. In each follow-up, patient will undergo a complete head and neck examination and will be assessed clinically for response and toxicities. Investigations will be done accordingly. CECT neck will be done 3 months post treatment to assess the tumor response and will be correlated clinically. Response will be assessed using RECIST version 1.1. Acute and late toxicities will be assessed and graded as per CTCAE version 5.0.
In this study, 44 patients recruited till closure of recruitment and planned hypofractionated IMRT using VMAT technique (55 Gy in 20#) plus 3 weekly Cisplatin 100 mg/sqm. Among them, 43 patients (97.7%) received full course of treatment and 1 patient (2.3%) did not complete (discontinued after 2# radiotherapy) the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Locally advanced, non-metastatic histopathology or cytology-proven, squamous cell carcinoma of Hypopharynx and Larynx (T3/T4a N0/N1/N2 M0) sent from multidisciplinary tumour board for CCRT.
- •Age 20 years to 65 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status up to
- •Haemoglobin ≥10 gm%, white blood cell count ≥4000/mm3, platelet count ≥1 lakh/mm3 (initially or after correction by blood transfusion).
- •Liver function test and kidney function test, both within normal limit.
- •Baseline audiometry limited to mild sensory neural deficits.
排除标准
- •Disease previously treated by radiotherapy, chemotherapy or surgery (other than biopsy and tracheostomy).
- •Age <20 years or >65 years.
- •Patients having significant medical co-morbidities.
- •Pregnancy or lactation.
- •Evidence of distant metastasis.
- •Patients unwilling to participate in the study or who do not give consent.
结局指标
主要结局
Evaluation of loco-regional response.
时间窗: Evaluation of loco-regional response will be assessed at 3 months after completion of treatment. | Assessment of toxicity (Acute and Late) during treatment and at 2 weeks, 4 weeks, 6 weeks, 3 months & 6 months after treatment.
Assessment of toxicity (Acute and Late).
时间窗: Evaluation of loco-regional response will be assessed at 3 months after completion of treatment. | Assessment of toxicity (Acute and Late) during treatment and at 2 weeks, 4 weeks, 6 weeks, 3 months & 6 months after treatment.
次要结局
- Assessment of disease-free survival.
