A Trial of Palliative Chemotherapy, Radiation and Immune Treatment for Oesophageal Cancer: PALEO … (NCT06290505) | Clinical Trial Compass
RecruitingPhase 2
A Trial of Palliative Chemotherapy, Radiation and Immune Treatment for Oesophageal Cancer: PALEO Study
Australia54 participantsStarted 2021-12-08
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Males and females \> 18 years of age.
✓. Biopsy proven adenocarcinoma or squamous cell carcinoma of the esophagus or gastro-oesophageal junction
✓. 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
✓. Symptomatic dysphagia (Mellow score greater than 0)
✓. ECOG performance status 0-2
✓. Anticipated life expectancy of greater than 12 weeks.
✓. Body weight of greater than 30kg.
✓. Adequate bone marrow function, with values within the ranges specified below. Blood transfusions are permissible.
Exclusion criteria
✕. Bulky or organ-threatening metastatic disease requiring upfront higher dose chemotherapy in the judgement of the treating clinician.
✕. Known tumour HER2 positivity (IHC 2+ or more and HER2 gene amplification on in situ hybridisation) if oligometastatic disease.
✕. Previous systemic therapy for oesophageal or GOJ carcinoma.
✕. Previous thoracic radiotherapy. Prior palliative radiotherapy to bony metastases is permitted.
What they're measuring
1
Progression free survival rate is the proportion of patients alive and progression free (the cancer has not worsened) assessed by CT scan and clinical review.
Timeframe: 6 months
Trial details
NCT IDNCT06290505
SponsorAustralasian Gastro-Intestinal Trials Group
✕. Major surgical procedure (as defined by the Investigator) within 28 days prior to first day of study treatment. Note: Local surgery of isolated lesions for palliative intent is permitted.