RecruitingPhase 2ACTRN12619001371189

A trial of palliative chemotherapy, Radiation and immune treatment for Oesophageal Cancer: PALEO Study

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

Sponsor

Australasian Gastro-Intestinal Cancer Trials Group

Enrollment

54 participants

Start Date

Nov 13, 2019

Study Type

Interventional

Conditions

Oesophageal Cancer

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 oesophageal cancer that has spread to another are of the body (metastasised). Who is it for? You may be eligible for this study if you are an adult who has cancer of the oesophagus or gastro-oesophageal junction that has spread to other parts of your body. Study details All participants in this study will receive 10 treatments of radiotherapy to the primary oesophageal cancer, with one treatment given on each working day for two weeks. In addition, all participants will receive chemotherapy (including carboplatin and paclitaxel) given intravenously once per week for the same two weeks as the radiotherapy. Durvalumab, an immune therapy, received intravenously; will be given every four weeks from the beginning of radiation therapy. After this participants will continue to receive immune therapy (Durvalumab), received intravenously once every 4 weeks for up to 24 months or until the cancer worsens. If participants have a metastatic tumour, they will also be given 3 doses of radiotherapy in one week. This radiotherapy will be received 4 weeks after the initial radiotherapy is completed. Safety blood tests will be collected through out the study (every two weeks from week 2 of treatment and then every four weeks from week 9 throughout the treatment and at other times if clinically indicated). Cat Scans to evaluate the response to treatment will be done every 6 weeks up to week 24 of treatment and then every 12 weeks or until the cancer worsens. Study participants will also be asked to complete some questionnaires about their wellbeing and nutritional status periodically through out the study. It is hoped that this trial can help determine if this chemotherapy with immune therapy and radiotherapy combination is effective in increasing the ability of the body’s immune system to prevent worsening of the cancer and improve swallowing.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Oesophageal cancer — cancer of the food pipe — is particularly difficult to treat once it has spread to other parts of the body. For these patients, the goal of treatment shifts toward controlling the disease, relieving symptoms like difficulty swallowing, and improving quality of life. This trial, called the PALEO Study, is testing a combination of standard radiotherapy and chemotherapy, along with an immunotherapy drug called durvalumab and targeted radiation to secondary tumours (stereotactic body radiotherapy). All participants will receive 10 sessions of radiotherapy to the primary tumour over two weeks, plus weekly chemotherapy (carboplatin and paclitaxel). Durvalumab immunotherapy will be given every four weeks from the start of treatment and continued for up to two years. Participants who have a secondary tumour elsewhere will also receive targeted radiation to that site about a month after the main treatment. You may be eligible if you are 18 or older, have biopsy-confirmed oesophageal or gastro-oesophageal junction cancer that has spread to 1 to 5 sites in the body, are experiencing difficulty swallowing, have a reasonable performance level, and have not previously received systemic therapy for this cancer. People with serious autoimmune conditions, active infections, or previous immunotherapy treatment are not eligible. This trial offers a structured, intensified approach for advanced oesophageal cancer with the aim of preserving the ability to swallow.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Participants will receive 2 weeks of therapy with concurrent hypofractionated radiotherapy (30Gy/10#), weekly carboplatin (AUC2), weekly paclitaxel (50mg/m2) and durvalumab (1500mg) intravenously every 4 weeks, followed by durvalumab monotherapy continuing at 1500mg intravenously every 4 weeks until disease progression or 24 months of therapy. A single metastasis will be treated with stereotactic radiotherapy (24Gy/3#) 4 weeks after the completion of the chemoradiotherapy to the primary tumour. Monitoring of adherence to treatment will be done by attendance at booked appointments