Using radiation therapy to treat 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)
This study tests if adding radiation therapy to immunotherapy can help people with metastatic gastrointestinal cancers feel better and improve their disease status.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Drugs / interventions | immunotherapy, radiation |
| Locations | 2 sites (San Francisco, California and 1 other locations) |
| Trial ID | NCT04221893 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of radiation therapy in patients with metastatic gastrointestinal cancers who are also receiving immunotherapy. The primary goal is to see if radiation can change the disease status from progressive to stable or responsive. Secondary objectives include assessing overall response rates, time to progression, overall survival, and the safety of the treatment. The study also explores the immune response and changes in circulating tumor DNA following radiation therapy.
Who should consider this trial
Good fit: Ideal candidates are patients with stage IV gastrointestinal cancers who are experiencing disease progression while on immunotherapy.
Not a fit: Patients whose cancers are not progressing or who do not have metastatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with advanced gastrointestinal cancers by potentially slowing or stopping cancer progression.
How similar studies have performed: Other studies have shown promising results with radiation therapy in combination with immunotherapy, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion 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 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).
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.
Where this trial is running
San Francisco, California and 1 other locations
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
- John Muir Medical Center-Walnut Creek — Walnut Creek, California, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Mary Feng, MD — University of California, San Francisco
- Study coordinator: Luchia Andemicael
- Email: luchia.andemicael@ucsf.edu
- Phone: (415) 530-9814
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.