Radiation Therapy for the Treatment of Metastatic Gastrointestinal Cancers

Description

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.

Conditions

Stage IV Esophageal Adenocarcinoma, Stage IV Esophageal Squamous Cell Carcinoma, Stage IV Gastric Cancer, Stage IV Adenocarcinoma of the Gastroesophageal Junction, Stage IVA Esophageal Adenocarcinoma, Stage IVA Esophageal Squamous Cell Carcinoma, Stage IVA Gastric Cancer, Stage IVA Adenocarcinoma of the Gastroesophageal Junction, Stage IVB Esophageal Adenocarcinoma, Stage IVB Esophageal Squamous Cell Carcinoma, Stage IVB Gastric Cancer, Stage IVB Gastroesophageal Junction Adenocarcinoma, Metastatic Anal Canal Carcinoma, Metastatic Colorectal Carcinoma, Metastatic Esophageal Carcinoma, Metastatic Gastric Carcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma, Metastatic Hepatocellular Carcinoma, Metastatic Malignant Digestive System Neoplasm, Metastatic Small Intestinal Carcinoma, Pancreatobiliary Carcinoma, Pathologic Stage IV Gastric Cancer AJCC v8, Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8, Pathologic Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8, Pathologic Stage IVB Esophageal Adenocarcinoma AJCC v8, Pathologic Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8, Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage IV Esophageal Squamous Cell Carcinoma AJCC v8, Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8, Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage IVA Esophageal Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8, Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage IVB Esophageal Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage IVB Esophageal Squamous Cell Carcinoma AJCC V8, Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8, Stage IV Anal Cancer AJCC v8, Stage IV Colorectal Cancer AJCC v8, Stage IV Hepatocellular Carcinoma AJCC v8, Stage IVA Colorectal Cancer AJCC v8, Stage IVA Hepatocellular Carcinoma AJCC v8, Stage IVB Colorectal Cancer AJCC v8, Stage IVB Hepatocellular Carcinoma AJCC v8, Stage IVC Colorectal Cancer AJCC v8

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Study Overview

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Study Details

Study overview

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.

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

Radiation Therapy for the Treatment of Metastatic Gastrointestinal Cancers

Condition
Stage IV Esophageal Adenocarcinoma
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California, San Francisco, San Francisco, California, United States, 94143

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 11. Ability to understand a written informed consent document, and the willingness to sign it.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, San Francisco,

Mary Feng, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

2027-11-30