Intensifying Radiation Treatment in Advanced/ Poor Prognosis Laryngeal, Hypopharyngeal (LH) and Oropharyngeal Cancers (OPC) Using PET -CT Based Dose Escalation Strategies ( INTELHOPE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of patients with Grade 3 through grade 5 adverse events that are related to dose escalation, graded according to NCI CTCAE version 4.0
研究概览
简要总结
The primary objective of the study is to establish the safety of using a moderate escalation of radiotherapy dose in advanced/poor prognosis OPC and LH cancers receiving curative radiotherapy.
The study will also explore the efficacy (improvement in complete response rates at 2 years) of dose escalation in intermediate and high risk OPC and LH cancers patients.
详细描述
Patients with locally advanced Laryngeal, Hypopharyngeal (LH) or oropharyngeal (OPC) head and neck squamous cell carcinomas have 5 year survival ranging between 25-45%. 60% of all LH cancers occur in the developing world and its incidence in India ranges from 1.8-8.8 per 1,00,000 population .
Local control outcomes of OPC patients with stage III and IV OPC has been modest with reported loco-regional control rates of 50-60% at 5 years. For patients with locally advanced LH a 60-70% 2 year survival is seen and loco-regional control rates of 70% have been reported . Majority of locally advanced OPC and LH cancers are treated with a combination of chemotherapy and radiotherapy (CRT) with organ and function preserving approach.
Identifying the area of tumour involvement in the OPC and LH could be challenging on CECT scans, requiring metabolic imaging with PET-CT for more precise definition of radiation target.
Improvements in radiation treatment delivery techniques have enabled clinicians to explore the possibility of improving tumour control probability (TCP) and reduce normal tissue complication probability . This allows us to explore the role of escalating dose in the above group of patients to assess the safety and efficacy of the regime.
Tumours treated in the standard dose arm will receive radiotherapy @ 220 cGy per fraction for 30 fractions whilst those in the escalated dose arm will receive @ 245 cGy per fraction for 30 fractions using IMRT techniques. Patients in both arms will receive weekly platinum based chemotherapy concurrent with radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •LH Inclusion Criteria ALL of the following inclusion criteria must be met
- •Histologically confirmed squamous cell cancer of the larynx or hypopharynx
- •Radiotherapy with concomitant chemotherapy as primary therapy
- •Induction chemotherapy is permitted
- •TNM Stage T3-4, N0-3, M0 or T1/2 with N2-3 disease (Stage III or IV a/b) disease
- •WHO performance status of 0 or 1
- •Creatinine clearance of more than 50ml/min
- •All patients must be suitable to attend regular follow up
- •OPC inclusion criteria ALL of the following inclusion criteria must be met
- •Histologically confirmed squamous cell cancer of the oropharynx
- •Radiotherapy with concomitant chemotherapy as primary therapy
- •Induction chemotherapy is permitted
- •WHO performance status of 0 or 1
- •Creatinine clearance of more than 50ml/min
- •All patients must be suitable to attend regular follow up
- •And any of the stage of disease as seen below HPV (p16) negative: TNM Stage T2-T4, any N stage, M0 disease HPV (p16) Positive: more than 10 pack year history and N2b or N3 disease
排除标准
- •The patient is ineligible if ANYONE of the following exclusion criteria is met
- •Previous radiotherapy to the head and neck region
- •Previous malignancy except non-melanoma skin cancer and early stage cancer in remission for at least 5 years following treatment
- •Previous or concurrent illness, which in the investigator's opinion would interfere with either completion of therapy or follow-up
- •Pre-existing previous speech or swallowing problems unrelated to the diagnosis of cancer
- •Patients with locally advanced LH tumours where organ preservation is unrealistic
- •Patients with metastatic carcinoma
- •OPC Exclusion Criteria The patient is ineligible if ANYONE of the following exclusion criteria is met
- •Previous radiotherapy to the head and neck region
- •Previous malignancy except non-melanoma skin cancer and early stage cancer in remission for at least 5 years following treatment
- •Previous or concurrent illness, which in the investigator's opinion would interfere with either completion of therapy or follow-up
- •Pre-existing previous speech or swallowing problems unrelated to the diagnosis of cancer
- •Patients with locally advanced LH or OPC tumours where organ preservation is unrealistic
- •Patients with metastatic carcinoma
- •Low risk OPC: HPV p16 positive T1-2 with N0-N2a disease or less than 10 pack year history
研究组 & 干预措施
Standard dose
Patients receive a radiation dose of 66Gy in 30 fractions to the planning target volume 1 (PTV1) and 54 Gy in 30 fractions to the PTV2 concurrent with platinum chemotherapy weekly
干预措施: Standard Dose (Radiation)
Escalated dose
Patients receive a radiation dose of 73.5 Gy in 30 fractions to the boost target volume (BTV), 63Gy in 30 fractions to PTV1 and 54 Gy in 30 fractions to PTV2 concurrent with platinum chemotherapy weekly
干预措施: Escalated Dose (Radiation)
结局指标
主要结局
Number of patients with Grade 3 through grade 5 adverse events that are related to dose escalation, graded according to NCI CTCAE version 4.0
时间窗: 2 years
In addition: Interim assessment for early stoppage is if 35% or more patients in the intervention arm has Grade 4 mucositis or dysphagia
次要结局
- Efficacy (improvement in complete response rates at 2 years) of dose escalation in intermediate and high risk Oropharyngeal cancer (OPC) patients and in node positive, locally advanced Laryngeal and Hypopharyngeal cancer patients.(2 years)