Study of Chemoradiotherapy in Oesophageal Cancer Including PET Response and Dose Escalation

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.

Conditions

• Oesophageal Cancer

Interventions

DRUG

Carboplatin

For more information please see the arm descriptions section.

DRUG

Paclitaxel

For more information please see the arm descriptions section.

DRUG

Cisplatin

For more information please see the arm descriptions section.

DRUG

Capecitabine

For more information please see the arm descriptions section.

RADIATION

Radiotherapy

For more information please see the arm descriptions section.

Sponsors & Collaborators

• Cancer Research UK

  collaborator OTHER

• Lisette Nixon

  lead OTHER_GOV

Principal Investigators

• Tom Crosby · Velindre University NHS Trust

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-11-04

Primary Completion

2021-04-30

Completion

2023-04-30

Countries

• United Kingdom

Study Locations