NCT06290505

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Australasian Gastro-Intestinal Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 esophageal cancer that is locally advanced or has spread to another area of the body (metastasized).

Detailed 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 esophageal cancer that is locally advanced or has spread to another area of the body (metastasized). Who is it for? Participant may be eligible for this study if participant is an adult who has cancer of the esophagus or gastro-esophageal junction that is locally advanced or has spread to other parts of the participant's body. Study details All participants in this study will receive 10 treatments of radiotherapy to the primary esophageal 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). CT 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 throughout 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.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	Durvalumab	Durvalumab will be supplied by AstraZeneca as a 500 mg vial concentrate for solution for infusion. The solution contains 50 mg/mL durvalumab, 26 mM histidine/histidine-hydrochloride, 275 mM trehalose dihydrate, and 0.02% weight/volume (w/v) polysorbate 80; it has a pH of 6.0 and density of 1.054 g/mL. The label-claim volume is 10 mL. Durvalumab is a sterile, clear to opalescent, colorless to slightly yellow solution, free from visible particles. Investigational product vials are stored at 2°C to 8°C and must not be frozen. Investigational product must be kept in original packaging until use to prevent prolonged light exposure.

Timeline

• Start date: 2021-12-08
• Primary completion: 2027-07-31
• Completion: 2029-07-31
• First posted: 2024-03-04
• Last updated: 2025-07-23

Locations

9 sites across 2 countries: Australia, New Zealand