Radiation Therapy for the Treatment of Metastatic Gastrointestinal Cancers

Official record

Identifier

NCT04221893

Recruiting locations

country

United States

Interventions studied

Radiation Therapy (RT)

Lead sponsor

University of California, San Francisco

Target enrolment

28 participants

Study type

INTERVENTIONAL

Phase

Not applicable

Status

Recruiting

First posted

Jan 9, 2020

Last updated on the registry

Aug 14, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

1. Patients must have a histologically, cytologically, or radiographically confirmed metastatic gastrointestinal (GI) malignancy (esophageal, gastroesophageal, gastric, small intestine, hepatocellular, pancreaticobiliary, colorectal, or anal cancer).
2. Patients must be receiving immunotherapy (checkpoint inhibitor or CTLA4 inhibitor) with overall response of progressive disease by RECIST criteria.
3. Patients must have at least one metastasis which is progressing as per RECIST criteria.
4. 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:

   * Symptomatic disease causing pain, bleeding, dyspnea, dysphagia, or nausea
   * At-risk for neurologic, respiratory, cardiovascular, gastrointestinal, musculoskeletal, or hepatobiliary compromise
5. Evaluation by a radiation oncologist within 28 days of study registration.
6. Must have adequate organ function to administer radiation therapy and immunotherapy as per standard of care.
7. Age \>= 18 years.
8. Life expectancy exceeding 6 months.
9. Eastern Cooperative Oncology Group (ECOG) 0-2 or Karnofsky performance status \>= 50.
10. Radiation therapy is known to be teratogenic and therefore women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of radiation therapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for 3 months after completion of radiation therapy. Contraception requirements during the follow-up period of 6 months will be according to standard of care for immunotherapy administration.

    a. If a woman is of child-bearing potential, a negative pregnancy test within 28 days prior to study enrollment is required.
11. Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

1. Enrollment on immunotherapy clinical trial for which radiation therapy is not permitted.
2. Administration of radiation therapy within 4 weeks prior to study enrollment.
3. Treatment with systemic corticosteroids or other immunosuppressive medications which would significantly diminish the effect of immunotherapy as judged by the treating physician.
4. Radiation therapy is contraindicated as adjudicated by the radiation oncologist.

Indexed under

Colorectal Cancer