NeoCREATE : Neoadjuvant Immune-Chemo-Radiotherapy in operable oEsophageal and gastro-oesophageal junction cancers with Carboplatin Paclitaxel Radiotherapy and Avelumab - a Trial assessing feasibility and preliminary Efficacy

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Multiple<Br/>Treatment TypesTypeMultiple
Treatment Types

TwoPhase Two

18+Age Over 18

Oesophagus<br/>CancersCancer LocationOesophagus
Cancers

Multiple treatment types,Radiotherapy,Systemic therapy | Stomach and upper gastrointestinal tractGastro-oesophageal junction ,Oesophagus

Trial Overview Read MoreRead more

This Phase II trial is trying to understand how safe and effective immunotherapy (avelumab) is in combination with chemotherapy (carboplatin and paclitaxel) and radiotherapy in people with operable oesophageal and gastro-oesophageal junction cancer.
 

This trial is treating patients with oesophageal and gastroeosophageal junction cancer.

This is a systemic therapy and radiotherapy trial.

You may be able to join this trial if:

  • You have been diagnosed with cancer, but have not received any treatment.
  • Your cancer has not spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

Neoadjuvant Immune-Chemo-Radiotherapy in operable oEsophageal and gastro-oesophageal junction cancers with Carboplatin Paclitaxel Radiotherapy and Avelumab - a Trial assessing feasibility and preliminary Efficacy

Commercial Sponsor

Merck

Summary

This is a non-randomised trial with one experimental arm, designed to assess the safety of chemo-radiotherapy-immunotherapy combination in patients with operable oesophageal and gastroeosophageal junction cancer. All participants will receive 5 weeks of weekly carboplatin-paclitaxel-radiotherapy. Avelumab will be given as intravenous infusion at the dose of 10mg/kg over 60 minutes in 250ml sodium chloride 0.9% every 2 weeks concurrently with chemoradiotherapy. A further two doses of 2 weekly avelumab will then be given alone.

Recruiting Hospitals Read MoreRead more

Monash Health, Medical Oncology
Clayton
GI Research Study Coordinator
gi.oncresearch@monashhealth.org
0436386758

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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