Actively Recruiting
A Trial of Palliative Chemotherapy, Radiation and Immune Treatment for Oesophageal Cancer: PALEO Study
Led by Australasian Gastro-Intestinal Trials Group · Updated on 2026-05-08
54
Participants Needed
9
Research Sites
398 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Trial of Palliative Chemotherapy, Radiation and Immune Treatment for Oesophageal Cancer: PALEO Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged over 18 years
- Biopsy-confirmed adenocarcinoma or squamous cell carcinoma of the esophagus or gastro-esophageal junction
- Oligometastatic disease (1-5 lesions outside the primary tumor area) or locally advanced disease unsuitable for surgery or radical chemoradiotherapy
- Symptomatic dysphagia (Mellow score > 0)
- ECOG performance status between 0 and 2
- Expected life expectancy greater than 12 weeks
- Body weight over 30 kg
- Adequate bone marrow function with specified minimum blood counts
- Adequate liver function within specified laboratory limits
- Adequate kidney function with serum creatinine and creatinine clearance meeting set thresholds
- Availability of tumor tissue for PD-L1 and MMR protein testing
- Willingness and ability to comply with all study requirements
- Signed informed consent
You will not qualify if you...
- Bulky or organ-threatening metastatic disease needing higher dose chemotherapy upfront
- Known HER2 positive tumor if oligometastatic
- Prior systemic therapy for esophageal or gastro-esophageal junction carcinoma
- Previous thoracic radiotherapy (except prior palliative radiotherapy to bone metastases)
- Presence of esophageal stent
- Known tracheo-esophageal fistula
- Known leptomeningeal or brain metastases
- Major surgery within 28 days before study treatment (except local palliative surgery)
- History of another cancer within last 3 years except certain treated skin and bladder cancers
- Prior therapy with immune checkpoint inhibitors or related drugs
- Grade 2 or higher sensory neuropathy
- Allergies or contraindications to study drugs or active autoimmune diseases (with some exceptions)
- Need for continuous systemic immunosuppressive treatment within 14 days prior to study drug
- Positive tests for acute or chronic hepatitis B or active hepatitis C infection
- Significant active infections including HIV or tuberculosis
- Prior solid organ or bone marrow transplant
- Receipt of live vaccine within 30 days before registration
- Use of alternative or traditional medicines within 14 days before registration
- Uncontrolled illness that may limit study compliance or increase risk
- Pregnancy, lactation, or inadequate contraception according to protocol requirements
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 9 locations
1
Canberra Hospital
Garran, Australian Capital Territory, Australia, 2605
Actively Recruiting
2
Border Medical Oncology
Albury, New South Wales, Australia, 2640
Active, Not Recruiting
3
Calvary Mater Newcastle
Newcastle, New South Wales, Australia, 2298
Actively Recruiting
4
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
Actively Recruiting
5
Flinders Medical Centre
Bedford Park, South Australia, Australia
Actively Recruiting
6
St Vincent's Hospital
Fitzroy, Victoria, Australia, 3065
Actively Recruiting
7
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
8
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
9
Auckland Hospital
Grafton, Auckland, New Zealand, 1023
Actively Recruiting
Research Team
S
Sandra Bahamad
CONTACT
S
Sukanya Sathyamurthie
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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