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Closed (no longer recruiting)Last updated: 7 February 2024

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

Clinical summary

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.

Conditions

This trial is treating patients with oesophageal and gastroeosophageal junction cancer

Cancer

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18+

Phase

II

Trial Acronym

NeoCREATE

More information

Trial Identifiers

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Trial sponsor

Merck

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

Eligibility

Inclusion

 

1. Male/female patients aged 18 years or older
2. Histologically confirmed gastro-oesophageal junction or oesophageal adenocarcinoma. Oesophageal and gastroesophageal junction tumours should be TNM7 stage T1-3 and N0-N1, with no evidence of distant metastases (M0) where the MDT believes that an R0 resection can be achieved at the outset. T4 or N2 cancers are excluded as per the CROSS trial eligibility and due to the possible variable need to prolong pre-operative chemotherapy or alternate chemotherapy regimen in CRT to reduce margin involvement and improve resectability.
3. Absence of distant metastases on CT scan and PET scan and staging laparoscopy (where indicated) prior to study entry.
4. No prior therapy for oesophageal or GOJ adenocarcinoma

Exclusion

 

1. Any contraindication or known hypersensitivity reaction to any of the study drugs, or components of carboplatin or paclitaxel.
2. Known severe hypersensitivity reactions to monoclonal antibodies (Grade equal to or greater than 3 NCI CTCAE v4.0), any history of anaphylaxis, or uncontrolled asthma (i.e., 3 or more features of partially controlled asthma).
3. Patients who have received immunotherapy for a previous malignancy.
4. Any previous malignancy, with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer.
5. Any other histology apart from adenocarcinoma are excluded
6. Any previous malignancy where patient has had less than or equal to 5 years of a disease free period. If patient has had greater than or equal to 5 years disease free period and where patient is deemed cured, patient may be eligible subject to Chief principle investigator decision.

Inclusion

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

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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