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RecruitingNot ApplicableNCT04221893

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)

Sponsor

University of California, San Francisco

Enrollment

28 participants

Start Date

Aug 7, 2020

Study Type

INTERVENTIONAL

Conditions

Metastatic Gastroesophageal Junction AdenocarcinomaMetastatic Hepatocellular CarcinomaStage IV Hepatocellular Carcinoma AJCC v8Stage IVA Hepatocellular Carcinoma AJCC v8Stage IVB Hepatocellular Carcinoma AJCC v8Metastatic Gastric CarcinomaMetastatic Colorectal CarcinomaPostneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8Stage IV Colorectal Cancer AJCC v8Metastatic Esophageal CarcinomaPathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8Stage IVA Colorectal Cancer AJCC v8Stage IVB Colorectal Cancer AJCC v8Stage IVC Colorectal Cancer AJCC v8Stage 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 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 v8Postneoadjuvant Therapy Stage IV Esophageal Squamous Cell Carcinoma AJCC v8Postneoadjuvant Therapy Stage IVA Esophageal Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8Postneoadjuvant Therapy Stage IVB Esophageal Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IVB Esophageal Squamous Cell Carcinoma AJCC V8Stage IV Anal Cancer AJCC v8

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether adding targeted radiation therapy to ongoing immunotherapy (cancer immune treatment) can help patients with gastrointestinal (GI) cancers whose disease is still growing despite immunotherapy alone. **You may be eligible if...** - You are 18 or older - You have a confirmed GI cancer (such as stomach, colon, liver, pancreatic, or anal cancer) that has spread - You are currently on immunotherapy but your cancer is still progressing - You have at least two sites of cancer, and at least one site needs radiation for symptom control - Your overall health is reasonably good (able to care for yourself) - Your life expectancy is more than 6 months **You may NOT be eligible if...** - You do not have metastatic GI cancer - Your cancer is not progressing on immunotherapy - You are not currently receiving immunotherapy - You are pregnant - You do not have adequate organ function Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONRadiation Therapy (RT)

Undergo radiation therapy

Locations(2)

University of California, San Francisco

San Francisco, California, United States

John Muir Medical Center-Walnut Creek

Walnut Creek, California, United States

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NCT04221893

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