A randomised Phase II/III trial to study radiotherapy dose escalation in patients with oesophageal cancer treated with definitive chemoradiation with an embedded Phase II trial for patients with a poor early response using positron emission tomography (PET)

Velindre NHS Trust0 sites439 target enrollmentOctober 26, 2016

Overview

No summary available.

Registry

who.int

Start Date

October 26, 2016

End Date

November 30, 2026

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Velindre NHS Trust

•Current participant inclusion criteria as of 14/02/2024:
•Patients meeting the following criteria may be included in the trial:
•1\. 16 years of age or older
•2\. Has been selected and is fit to receive potentially curative definitive chemoradiotherapy by a specialist Upper GI MDT\*.
•3\. Histologically confirmed adenocarcinoma, undifferentiated cancer or squamous cell carcinoma.
•4\. Tumours of the cervical, thoracic oesophagus, or gastro\-oesophageal junction (GOJ) with proximal extent of disease no more proximal than 15cm ab oral and distal extent of primary tumour no more than 2 cm beyond the GOJ.
•5\. Tumours staged as T1\-4 and N\+/\-, to be determined by TNM 7th (2010\) edition of the AJCC/UICC manual. M1 nodes which are encompassable within the radical radiotherapy volume are eligible.
•6\. Total disease length (including primary tumour and involved lymph nodes) \=13cm. The primary tumour should also be \=10cm.
•7\. WHO performance status 0\-1 (appendix 1\).
•8\. Adequate cardiovascular function for safe delivery of chemo\-radiation in the opinion of the principal investigator. Where there is clinical concern patients should have an adequate cardiac ejection fraction \= 40% as determined by MUGA scan or ECHO (within 4 weeks prior to enrolment).

•Current participant exclusion criteria as of 14/02/2024:
•If any of the following criteria apply, patients cannot be included in the trial:
•1\. Patients who have had previous treatment for invasive oesophageal carcinoma or gastro\-oesophageal junction carcinoma (not including PDT or laser therapy for high\-grade dysplasia/carcinoma in\-situ).
•2\. Patients with metastatic disease. (unless M1 encompassable in the radical RT field)
•3\. Patients with other active malignancy or past malignancy which is deemed to have significant impact on their prognosis over the next three years.
•4\. Patients with \>2cm mucosal extension of tumour into the stomach or where the superior extent is proximal to 15 cm ab oral.
•5\. Patients with unstable angina or uncontrolled hypertension or cardiac failure or other clinically significant cardiac disease.
•6\. Patients who need continued treatment with a contraindicated concomitant medication or therapy.
•7\. Patients with serious infections which in the opinion of the investigator make delivery of chemotherapy inappropriate.
•8\. Known hypersensitivity to IMPs.