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RecruitingLast updated:30 May 2023

PALEO: The purpose of this study is to investigate the effects of the addition of stereotactic body radiotherapy and immunotherapy (durvalumab) to a well tolerated 2-week chemotherapy and radiation treatment regimen in people with oesophageal cancer that has spread to another area of the bodyPhase II clinical trial of chemoradioimmunotherapy for the ALleviation of oEsOphageal cancer complications

Clinical summary

Summary

Eligible participants will receive 10 treatments of radiation therapy to the primary oesophageal cancer, with one treatment given on each working day for 2 weeks. In addition, all participants will receive chemotherapy (including carboplatin and paclitaxel) given intravenously once per week for the same 2 weeks as the radiation therapy. Durvalumab (immunotherapy) will be given intravenously every 4 weeks from the beginning of radiation therapy. After this, participants will continue to receive durvalumab intravenously once every 4 weeks for up to 24 months. If the participants have a metastatic tumour, they will also be given 3 doses of radiation therapy in one week. This radiation therapy will be received 4 weeks after the initial radiation therapy is completed. It is hoped that this trial can help determine if this chemotherapy with immunotherapy and radiation therapy combination is effective in increasing the ability of the body's immune system to prevent worsening of the cancer and improve swallowing.

Age

People18+

Phase

II

Trial Acronym

PALEO

More information

Trial Identifiers

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Commercial Sponsor

Varian Medical Systems, Inc, Australasian Gastro-Intestinal Trials Group (AGITG)

Scientific Title

Phase II clinical trial of chemoradioimmunotherapy for the ALleviation of oEsOphageal cancer complications

Eligibility

Inclusion

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

Exclusion

  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.
Message

Clinical trials have complex eligibility criteria.

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