RECRUITING

Radiation Therapy for the Treatment of Metastatic Gastrointestinal Cancers

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Conditions

Stage IV Esophageal AdenocarcinomaStage IV Esophageal Squamous Cell CarcinomaStage IV Gastric CancerStage IV Adenocarcinoma of the Gastroesophageal JunctionStage IVA Esophageal AdenocarcinomaStage IVA Esophageal Squamous Cell CarcinomaStage IVA Gastric CancerStage IVA Adenocarcinoma of the Gastroesophageal JunctionStage IVB Esophageal AdenocarcinomaStage IVB Esophageal Squamous Cell CarcinomaStage IVB Gastric CancerStage IVB Gastroesophageal Junction AdenocarcinomaMetastatic Anal Canal CarcinomaMetastatic Colorectal CarcinomaMetastatic Esophageal CarcinomaMetastatic Gastric CarcinomaMetastatic Gastroesophageal Junction AdenocarcinomaMetastatic Hepatocellular CarcinomaMetastatic Malignant Digestive System NeoplasmMetastatic Small Intestinal CarcinomaPancreatobiliary CarcinomaPathologic Stage IV Gastric Cancer AJCC v8Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8Pathologic Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IVB Esophageal Adenocarcinoma AJCC v8Pathologic Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IV Esophageal Squamous Cell Carcinoma AJCC v8Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IVA Esophageal Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IVB Esophageal Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IVB Esophageal Squamous Cell Carcinoma AJCC V8Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8Stage IV Anal Cancer AJCC v8Stage IV Colorectal Cancer AJCC v8Stage IV Hepatocellular Carcinoma AJCC v8Stage IVA Colorectal Cancer AJCC v8Stage IVA Hepatocellular Carcinoma AJCC v8Stage IVB Colorectal Cancer AJCC v8Stage IVB Hepatocellular Carcinoma AJCC v8Stage IVC Colorectal Cancer AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2020-08-07
Study Completion:2027-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04221893

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Patients must be receiving immunotherapy (checkpoint inhibitor or CTLA4 inhibitor) with overall response of progressive disease by RECIST criteria.
  3. 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. 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:
  5. * Symptomatic disease causing pain, bleeding, dyspnea, dysphagia, or nausea
  6. * At-risk for neurologic, respiratory, cardiovascular, gastrointestinal, musculoskeletal, or hepatobiliary compromise
  7. 5. Evaluation by a radiation oncologist within 28 days of study registration.
  8. 6. Must have adequate organ function to administer radiation therapy and immunotherapy as per standard of care.
  9. 7. Age \>= 18 years.
  10. 8. Life expectancy exceeding 6 months.
  11. 9. Eastern Cooperative Oncology Group (ECOG) 0-2 or Karnofsky performance status \>= 50.
  12. 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.
  13. 11. Ability to understand a written informed consent document, and the willingness to sign it.
  1. 1. Enrollment on immunotherapy clinical trial for which radiation therapy is not permitted.
  2. 2. Administration of radiation therapy within 4 weeks prior to study enrollment.
  3. 3. Treatment with systemic corticosteroids or other immunosuppressive medications which would significantly diminish the effect of immunotherapy as judged by the treating physician.
  4. 4. Radiation therapy is contraindicated as adjudicated by the radiation oncologist.

Contacts and Locations

Study Contact

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

Principal Investigator

Mary Feng, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of California, San Francisco

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-07
Study Completion Date2027-11-30

Study Record Updates

Study Start Date2020-08-07
Study Completion Date2027-11-30

Terms related to this study

Additional Relevant MeSH Terms

  • 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