A Trial of Palliative Chemotherapy, Radiation and Immune Treatment for Oesophageal Cancer: PALEO Study — PALEO  

Oesophageal Cancer Clinical Trial

Official title: PALEO: Phase II Clinical Trial of Chemoradioimmunotherapy for the ALleviation of oEsOphageal Cancer Complications

Status Recruiting

Clinical Trial Summary

The purpose of this study is to investigate the effects of the addition of the stereotactic body radiotherapy and durvalumab to a well tolerated 2 week chemotherapy and radiation treatment regimen in people with oesophageal cancer that has spread to another are of the body (metastasised).

Clinical Trial Description

The purpose of this study is to investigate the effects of the addition of the stereotactic body radiotherapy and durvalumab to a well tolerated 2 week chemotherapy and radiation treatment regimen in people with oesophageal cancer that has spread to another are of the body (metastasised).

Who is it for?

Patients may be eligible for this study if they are an adult who has cancer of the oesophagus or gastro-oesophageal junction that has spread to other parts of their body.

Study details

All participants in this study will receive 10 treatments of radiotherapy to the primary oesophageal cancer, with one treatment given on each working day for two weeks. In addition, all participants will receive chemotherapy (including carboplatin and paclitaxel) given intravenously once per week for the same two weeks as the radiotherapy. Durvalumab, an immune therapy, received intravenously; will be given every four weeks from the beginning of radiation therapy.

After this, participants will continue to receive immune therapy (Durvalumab), received intravenously once every 4 weeks for up to 24 months or until the cancer worsens. If participants have a metastatic tumour, they will also be given 3 doses of radiotherapy in one week. This radiotherapy will be received 4 weeks after the initial radiotherapy is completed.

Safety blood tests will be collected throughout the study (every two weeks from week 2 of treatment and then every four weeks from week 9 throughout the treatment and at other times if clinically indicated). Cat Scans to evaluate the response to treatment will be done every 6 weeks up to week 24 of treatment and then every 12 weeks or until the cancer worsens. Study participants will also be asked to complete some questionnaires about their wellbeing and nutritional status periodically through out the study.

It is hoped that this trial can help determine if this chemotherapy with immune therapy and radiotherapy combination is effective in increasing the ability of the body's immune system to prevent worsening of the cancer and improve swallowing. ;

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Oesophageal Cancer

• NCT number: NCT06290505
• Study type: Interventional
• Source: Australasian Gastro-Intestinal Trials Group
• Contact: Julia Kuszewski
• Phone: +61 2 7208 2725
• Email: julia@gicancer.org.au
• Status: Recruiting
• Phase: Phase 2
• Start date: December 8, 2021
• Completion date: January 31, 2028