A clinical trial to investigate if proton beam therapy with chemotherapy given before surgery for patients with oesophageal cancer that has spread to the surrounding tissues, significantly reduces the severe side effects to the heart and lungs and allows immunotherapy to be started sooner after surgery when compared with standard radiotherapy and chemotherapy before surgery, and whether this delivers value to the NHS and patients
- Conditions
- Oesophageal cancerCancer
- Registration Number
- ISRCTN50098578
- Lead Sponsor
- niversity College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 170
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency and percentage of patients that experience severe post operative complications prior to or at the follow-up assessment 3 months after surgery measured using adverse event data entered on the database by sites which is graded using both the CTCAE and the Clavien Dindo Scale
- Secondary Outcome Measures
Name Time Method Preliminary data on longer term efficacy outcomes following 1 year of adjuvant immunotherapy for patients that do not achieve pathologic complete response at surgery measured using survival data and the number and percentages of different types of disease recurrences