ISRCTN50098578进行中（未招募）Unknown
A randomised phase 2 trial comparing proton versus photon-based neoadjuvant chemoradiation, followed by adjuvant immunotherapy, in oesophageal cancer
niversity College London0 个研究点目标入组 170 人开始时间: 2024年2月15日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 170
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. 16 years of age or older
- •2. Histologically confirmed diagnosis of oesophageal adenocarcinoma (OAC) or squamous cell carcinoma (OSCC)
- •3. Tumour of the thoracic oesophagus or gastroesophageal junction with distal maximum extension no more than 3 cm beyond the gastroesophageal junction
- •4. cT stage > = 2 and/or cN stage > = 0-2 defined by AJCC 8th edition
- •5. ECOG performance status 0–1
- •6. Suitable for and fit to receive curative neoadjuvant Chemoradiotherapy followed by surgery by an Upper GI MDT
- •7. Suitable for and fit to receive adjuvant Immunotherapy according to local guidelines
- •8. Adequate cardiovascular and respiratory function for surgery in the opinion of the surgical team within 4 weeks prior to randomisation
- •9. Willing and able to give written informed consent and able to comply with treatment and follow up schedule
- •10. Willing and able to undergo treatment at a PBT centre (i.e. UCLH or The Christie) if randomised to Proton Arm
排除标准
- •1. Metastatic disease or extensive nodal disease (N3).
- •2. Patients who have had previous treatment for invasive oesophageal carcinoma or gastro-oesophageal junction carcinoma (including Photo Dynamic Therapy or laser therapy for high grade dysplasia/carcinoma in-situ).
- •3. Patients with > 3cm mucosal extension of tumour into the stomach beyond the GOJ or where the superior extent is in the cervical oesophagus
- •4. Total length of disease (primary tumour and involved lymph nodes) length > 8 cm
- •5. Patients with unstable angina, uncontrolled hypertension, cardiac failure or arrhythmia and other clinically significant cardiac disease.
- •6. Patients with an oesophageal stent (patients requiring a PEG/RIG/feeding jejunostomy for nutritional purposes ARE eligible).
- •7. No relevant co-morbidities, including Usual Interstitial Pneumonia (UIP) pulmonary fibrosis and connective tissue disorders.
- •8. History of other malignancy likely to interfere with the protocol treatment (e.g. patients with previously treated malignancy who have been disease-free for < 1 year, or patients with active malignancy undergoing treatment). Exceptions:
- •8.1. Subjects who have been successfully treated and disease-free for > 3 years,
- •8.2. A history of treated non-melanoma skin cancer,
- •8.3. Successfully treated in situ carcinoma,
- •8.4. CLL in stable remission, or indolent prostate cancer requiring no or only anti-hormonal therapy.
- •9. Any other situation, which in the opinion of the local PI, makes the patient unsuitable for this trial.
- •10. Women who are pregnant or breastfeeding.
- •11. Patients unable to adhere to the contraception guidance in the protocol.
研究者
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