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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAustralasian Gastro-Intestinal Trials Group

About this trial

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

Qualifiers

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)

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Durvalumab

Treatment groups

54 Participants
are divided into 1 treatment group