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Radiation Therapy for the Treatment of Metastatic Gastrointestinal Cancers

Phase II Study of Hypofractionated Radiation Therapy to Augment Immune Response in Patients With Metastatic GastroIntestinal Malignancies Progressing on Immune Therapy (ARM-GI)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 36 months
  • Procedures mentioned: X-rays

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors."
  • "After completion of study treatment, patients are followed up at 14 day, 6 months, and then up to 36 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether radiation can slow or stop cancer growth in adults with digestive system cancers that have spread and are getting worse during immunotherapy, a treatment that helps the immune system fight cancer. Radiation uses high-energy x-rays to kill cancer cells. Researchers also want to see if treating one tumor helps the immune system attack other tumors.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be 18 or older and have a confirmed digestive system cancer that has spread to other parts of the body.
  • You must be getting immunotherapy, and your cancer must be getting worse, including at least one tumor where the cancer has spread.
  • You must have 1 to 5 cancer sites that need radiation to ease symptoms or prevent harm, as judged by a radiation doctor.
  • You must see a radiation doctor within 28 days of signing up, and your organs must work well enough for radiation and immunotherapy.
  • You must be expected to live more than 6 months and meet the study's rating for how well you can do daily activities.
  • If you can become pregnant, you must have a negative pregnancy test within 28 days before joining.
  • You must follow the study's birth control rules before and during radiation. Men must continue for 3 months after radiation. During the 6-month follow-up, birth control rules follow usual immunotherapy care. Tell your doctor right away about a possible pregnancy.
  • You must be able to understand and be willing to sign a written consent form.

Who can't join

  • You are in an immunotherapy study that does not allow radiation.
  • You had radiation within 4 weeks before joining.
  • You take steroids or other medicines that weaken the immune system enough to greatly reduce immunotherapy's effect, as judged by your doctor.
  • Your radiation doctor decides that radiation is not safe or suitable for you.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (2)

CA