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Recruiting NCT04221893

Radiation Therapy for the Treatment of Metastatic Gastrointestinal Cancers

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Plain-language summary for patients

Trial Parameters

Condition Stage IV Esophageal Adenocarcinoma
Sponsor University of California, San Francisco
Study Type INTERVENTIONAL
Phase N/A
Enrollment 28
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2020-08-07
Completion 2026-06-30
All 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
Interventions
Radiation Therapy (RT)

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Brief 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 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 neurolo

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