RecruitingNot Applicable

Radiation Therapy for the Treatment of Metastatic Gastrointestinal Cancers

United States28 participantsStarted 2020-08-07

Plain-language summary

This phase II trial studies how well radiation therapy works for the treatment of gastrointestinal cancer that are spreading to other places in the body (metastatic). Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. This trial is being done to determine if giving radiation therapy to patients who are being treated with immunotherapy and whose cancers are progressing (getting worse) can slow or stop the growth of their cancers. It may also help researchers determine if giving radiation therapy to one tumor can stimulate the immune system to attack other tumors in the body that are not targeted by the radiation therapy.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients must have a histologically, cytologically, or radiographically confirmed metastatic gastrointestinal (GI) malignancy (esophageal, gastroesophageal, gastric, small intestine, hepatocellular, pancreaticobiliary, colorectal, or anal cancer).
✓. Patients must be receiving immunotherapy (checkpoint inhibitor or CTLA4 inhibitor) with overall response of progressive disease by RECIST criteria.
✓. Patients must have at least two metastases which are individually progressing as per RECIST criteria, one of which can be safely unirradiated as adjudicated by the treating radiation oncologist (e.g. lesions for which small increases in dimensions are unlikely to precipitate significant symptoms).
✓. Patients must have 1-5 sites of disease meeting standard-of-care indications for palliative radiation therapy as adjudicated by the treating radiation oncologist. For example:
✓. Evaluation by a radiation oncologist within 28 days of study registration.
✓. Must have adequate organ function to administer radiation therapy and immunotherapy as per standard of care.
✓. Age \>= 18 years.
✓. Life expectancy exceeding 6 months.

Exclusion criteria

What they're measuring

Overall response rate (ORR)

Timeframe: Up to 8 weeks

Trial details

NCT IDNCT04221893

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Luchia Andemicael

(415) 530-9814 luchia.andemicael@ucsf.edu

View on ClinicalTrials.gov More Stage IV Esophageal Adenocarcinoma trials