NCT06290505 A Trial of Palliative Chemotherapy, Radiation and Immune Treatment for Oesophageal Cancer: PALEO Study
| NCT ID | NCT06290505 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Australasian Gastro-Intestinal Trials Group |
| Condition | Esophageal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2021-12-08 |
| Primary Completion | 2027-07-31 |
Trial Parameters
Eligibility Fast-Check
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Brief 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).
Eligibility Criteria
Inclusion Criteria: 1. Males and females \> 18 years of age. 2. Biopsy proven adenocarcinoma or squamous cell carcinoma of the esophagus or gastro-oesophageal junction 3. Oligometastatic disease (1-5 lesions outside the primary tumour radiotherapy field on FDG-PET scan), or locoregionally advanced disease unsuitable for either surgical resection or radical chemoradiotherapy 4. Symptomatic dysphagia (Mellow score greater than 0) 5. ECOG performance status 0-2 6. Anticipated life expectancy of greater than 12 weeks. 7. Body weight of greater than 30kg. 8. Adequate bone marrow function, with values within the ranges specified below. Blood transfusions are permissible. 1. White blood cell count greater than or equal to 2 x (10 to the power of 9)/L 2. Absolute neutrophil count greater than or equal to 1.5 x (10 to the power of 9)/L 3. Platelets greater than or equal to 100 x (10 to the power of 9)/L 4. Haemoglobin greater than or equal to 90g/L 9. Adequate liver function, with values within
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