Radiation Therapy for the Treatment of Metastatic Gastrointestinal Cancers
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Esophageal Carcinoma
- Metastatic Anal Canal Carcinoma
- Postneoadjuvant Therapy Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8
- Stage IVB Gastroesophageal Junction Adenocarcinoma
- Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
- Stage IV Esophageal Squamous Cell Carcinoma
- Stage IVB Esophageal Squamous Cell Carcinoma
- Stage IVA Adenocarcinoma of the Gastroesophageal Junction
- Stage IVA Esophageal Adenocarcinoma
- Stage IV Esophageal Adenocarcinoma
- Stage IV Gastric Cancer
- Stage IV Hepatocellular Carcinoma AJCC v8
- Metastatic Colorectal Carcinoma
- Stage IVA Colorectal Cancer AJCC v8
- Stage IVA Esophageal Squamous Cell Carcinoma
- Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
- Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8
- Stage IVB Gastric Cancer
- Postneoadjuvant Therapy Stage IVA Esophageal Adenocarcinoma AJCC v8
- Metastatic Gastric Carcinoma
- Stage IV Adenocarcinoma of the Gastroesophageal Junction
- Stage IVA Gastric Cancer
- Postneoadjuvant Therapy Stage IVB Esophageal Adenocarcinoma AJCC v8
- Stage IV Anal Cancer AJCC v8
- Stage IVA Hepatocellular Carcinoma AJCC v8
- Pathologic Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8
- Stage IVB Hepatocellular Carcinoma AJCC v8
- Stage IVC Colorectal Cancer AJCC v8
- Pathologic Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8
- Metastatic Gastroesophageal Junction Adenocarcinoma
- Metastatic Hepatocellular Carcinoma
- Metastatic Malignant Digestive System Neoplasm
- Stage IVB Esophageal Adenocarcinoma
- Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
- Metastatic Small Intestinal Carcinoma
- Pancreatobiliary Carcinoma
- Postneoadjuvant Therapy Stage IV Esophageal Squamous Cell Carcinoma AJCC v8
- Stage IV Colorectal Cancer AJCC v8
- Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
- Pathologic Stage IV Gastric Cancer AJCC v8
- Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8
- Pathologic Stage IVB Esophageal Adenocarcinoma AJCC v8
- Stage IVB Colorectal Cancer AJCC v8
- Postneoadjuvant Therapy Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVE: I. To determine whether radiation therapy can convert overall response rates from progressive disease to stable or responsive disease as measured by Response Evaluation Criteria in Solid Tumors (RECIST) version (v.) 1.1. SECONDARY OBJECTIVES: I. To define overall response rate by ...
PRIMARY OBJECTIVE: I. To determine whether radiation therapy can convert overall response rates from progressive disease to stable or responsive disease as measured by Response Evaluation Criteria in Solid Tumors (RECIST) version (v.) 1.1. SECONDARY OBJECTIVES: I. To define overall response rate by immune-Modified Response Evaluation Criteria in Solid Tumors (iRECIST) criteria. II. To determine time to progression. III. To determine overall survival. IV. To determine local control in radiated lesion(s). V. To characterize the effect of distant radiation on unirradiated target lesions. VI. To describe the incidence of new metastatic lesions. VII. To determine treatment safety by Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0. VIII. To describe time to new systemic therapy. EXPLORATORY OBJECTIVES: I. To define radiation-induced effects on circulating immune cells. II. To describe remodeling of the circulating T cell repertoire by deep sequencing of variable, diversity and joining (VDJ) regions of T cell receptors (TCRs). III. To describe changes in circulating tumor deoxyribonucleic acid (DNA) (ctDNA). OUTLINE: Patients undergo radiation therapy for a total of 5 treatments over 5-9 calendar days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 14 day, 6 months, and then up to 36 months.
Tracking Information
- NCT #
- NCT04221893
- Collaborators
- Varian Medical Systems
- Investigators
- Principal Investigator: Mary Feng, MD University of California, San Francisco