A Prospective, Phase II, Randomized Controlled Trial of Intensity Modulated Radiation Therapy (IMRT) versus Intensity Modulated Proton Therapy (IMPT) in Nasopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS) and overall survival (OS)
研究概览
简要总结
Nasopharyngeal Carcinoma (NPC) is a rare type of epithelial cancer originating from the nasopharynx lining, with distinct epidemiological features. It is most common in Southern China and Southeast Asia, while in India, its prevalence is notably higher in the North-Eastern states.
NPC often affects younger patients and shows high radiosensitivity, making radiotherapy (RT) the primary treatment. Historically, treatment evolved from 2D-RT to 3D-CRT, and now Intensity Modulated Radiation Therapy (IMRT) is the standard due to its precision and reduced toxicity to normal tissues.
Despite the success of IMRT in improving survival and reducing side effects like xerostomia and hearing loss, 30-40% of patients still suffer from moderate to severe late toxicities, which negatively impact long-term quality of life (QoL).
To enhance outcomes and reduce side effects further, chemotherapy has been combined with RT, especially in advanced-stage NPC, as proven by landmark trials like Intergroup 0099, NPC-9901, and NPC-0501. Neoadjuvant chemotherapy (NACT) followed by concurrent chemoradiotherapy (CRT) is now considered the standard for Stage III–IVA NPC.
A promising alternative is Intensity Modulated Proton Therapy (IMPT), an advanced form of Proton Beam Therapy (PBT). Due to the unique physical properties of protons (sharp dose fall-off), IMPT can deliver high tumor doses while sparing surrounding healthy tissues. Early clinical and dosimetric studies show IMPT may significantly reduce toxicities (e.g., xerostomia, hearing loss) and improve QoL compared to IMRT.
However, evidence from randomized trials is lacking, especially in Indian populations. Therefore, a Phase II Randomized Controlled Trial is proposed to compare IMRT vs. IMPT in NPC, aiming to establish stronger evidence on reducing long-term toxicity and improving patient outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients diagnosed with histopathologically confirmed NPC: squamous, undifferentiated or poorly differentiated carcinoma 2.Age more than or equal to 18 years 3.Stage II-IVA NPC (as per the 8th AJCC staging) 4.Planned for treatment with curative intent 5.Willing to undergo treatment at TMC Proton Therapy Centre 6.Willing to give informed consent 7.Patients who have received standard neoadjuvant chemotherapy outside/TMH and have a baseline pre-treatment imaging and staging information available.
排除标准
- •1.Patients with oligometastatic or metastatic disease 2.Other nasopharyngeal histopathologies like sarcomas, adenocarcinoma, lymphoma etc.
- •3.Significant comorbidities precluding combined modality treatment with chemotherapy and/or radiotherapy 4.Patients with synchronous or metachronous primary 5.Patients who have received prior RT to the head and neck region 6.Patients with pre-existing significant salivary gland pathology 7.Incompletely or partially treated NPC.
结局指标
主要结局
Progression-free survival (PFS) and overall survival (OS)
时间窗: Progression-free survival (PFS) and overall survival (OS) at 1 year
次要结局
- To assess patient reported xerostomia and hearing loss post treatment in both the arms
- Objective evaluation of xerostomia using salivary scintigraphy post RT in both the arms(baseline, 3 months, 6 months, 1 year and 2 years post RT completion)
- To assess Quality of Life (QoL) in both the arms(baseline, at RT conclusion, 3 months, 6 months, 1 year and 2 years post RT completion.)
- Comparison of other radiation-related acute- and late-toxicities in both the arms
- To assess the cost effectiveness of IMPT over IMRT(baseline, at RT conclusion, 3 months, 6 months, 1 year and 2 years post RT completion.)