Clinical Trials Logo

Clinical Trial Summary

Research has shown that increasing the dose of radiotherapy improves outcomes in patients with lung and head and neck cancers. This study aims to see whether this is also the case for patients with tumour of the oesophagus. This trial will compare the effects of the standard dose of radiotherapy to a higher dose whilst closely monitoring the side effects.

A comparison will also be made regarding the effects of the standard drugs used in chemotherapy (cisplatin and capecitabine) with an alternative combination (carboplatin and paclitaxel) in patients that do not show a response to chemotherapy with standard drugs early on in treatment.

All patients will receive 6 weeks of chemotherapy and 5 weeks of chemoradiotherapy.

How the study will be conducted:

Prior to the commencement of treatment each patient will have a special scan called a PET scan. Patients will receive a second PET scan two weeks after the start of standard chemotherapy. The changes between the two scans will then be used to allocate treatment into the different arms of the study. All study subjects will be randomised to receive either the standard radiotherapy dose or the high radiotherapy dose. The participants that do not respond to the first cycle of standard chemotherapy will be eligible to take part in the aspect of the trial looking at an alternative chemotherapy regimen. Patients will be randomised as follows;

On the basis of the second PET scan, patients who are not responding to standard chemotherapy will be allocated by a computer to one of the four groups detailed below:

- Standard chemotherapy and standard dose of radiotherapy

- Standard chemotherapy and higher dose of radiotherapy

- Alternative chemotherapy and standard dose of radiotherapy

- Alternative chemotherapy and higher dose of radiotherapy

Patients who are responding to standard chemotherapy (or where the response is unknown or those who were not eligible for PET scan portion of the study) will be allocated by a computer to one of two groups detailed below:

- Standard chemotherapy and standard dose of radiotherapy

- Standard chemotherapy and higher dose of radiotherapy

The arms within each of the groups above (responders and non-responders) will be equal in size and patients will be allocated randomly by a computer.

This study will also compare the way that this treatment affects the two different cell types found in oesophageal tumours.

The effects of the different treatment, together with the costs of the different treatment and the effects on quality of life will be analysed to see which is more effective for each of the different groups.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02741856
Study type Interventional
Source Velindre NHS Trust
Contact Sarah Bridges
Phone +44 2920 687869
Email scope2@cardiff.ac.uk
Status Recruiting
Phase Phase 2/Phase 3
Start date November 4, 2016
Completion date April 2023

See also
  Status Clinical Trial Phase
Recruiting NCT05685862 - Laser Speckle Contrast Imaging, Surgical Eye & ICG Fluorescence Imaging for Perfusion Assessment of the Gastric Conduit
Recruiting NCT01795768 - Proof-of-Concept Study of AZD4547 in Patients With FGFR1 or FGFR2 Amplified Tumours Phase 2
Completed NCT05266300 - Implementation and Quality Assurance of DPYD-genotyping in Patients Treated With Fluoropyrimidines.
Recruiting NCT03978377 - Cardiopulmonary Toxicity of Thoracic Radiotherapy
Active, not recruiting NCT03653052 - Do Changes in ctDNA Predict Response for Patients With Oesophageal Cancer Receiving Durvalumab Phase 2
Recruiting NCT04484636 - PLATON - Platform for Analyzing Targetable Tumor Mutations (Pilot-study) N/A
Recruiting NCT05489250 - The PLATON Network
Terminated NCT01795976 - NY-ESO-1 T Cells in OG Cancer Phase 2
Recruiting NCT01843829 - A Feasibility Study of Chemo-radiotherapy to Treat Operable Oesophageal Cancer Phase 2
Completed NCT01915693 - ROCS (Radiotherapy After Oesophageal Cancer Stenting) Study Phase 3
Completed NCT02382237 - Comparison of Tumor Glucose Metabolism Before and After Artificial Nutrition N/A
Recruiting NCT04517448 - Quality of Life of Patients Over 75 Yars Undergoing Palliative Chemotherapy
Recruiting NCT04232735 - Evidence Based Information Provision to Improve Decision Making After Oesophagogastric Cancer Diagnosis (SOURCE) N/A
Recruiting NCT05642819 - REVOLUTION Surgery (REVOLUTION Surgery)
Recruiting NCT04001478 - Non-invasive Testing for Early oEesophageal Cancer and Dysplasia
Not yet recruiting NCT05600608 - Augmentation of Volatile Biomarkers of Oesophageal and Gastric Adenocarcinoma From the Tumour Lipidome N/A
Recruiting NCT04481256 - TGF-β And PDL-1 Inhibition in Esophageal Squamous Cell Carcinoma Combined With Chemoradiation TheRapY N/A
Recruiting NCT05057013 - HMBD-001 in Advanced HER3 Positive Solid Tumours Phase 1/Phase 2
Not yet recruiting NCT06046846 - Prehabilitation Via a Mobile Application in Oesophago-gastric Cancer N/A
Recruiting NCT04564482 - PD-L1 PET Imaging During Neoadjuvant (Chemo)Radiotherapy in Esophageal and Rectal Cancer N/A