Radiation Therapy for the Treatment of Metastatic Gastrointestinal Cancers

NCT04221893 | Recruiting DMC FDA Device

• 2 other identifiers: 19721NCI-2019-08355
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  Proportion of patients who achieve as their best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1 criteria: Stable disease (SD), partial response (PR), confirmed Complete Response (CR), or progressive disease (PD). Corresponding exact confidence intervals will be reported for the entire cohort and stratified by histologic subtype, programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) status, microsatellite instability (MSI), and organs treated if sample size allows. Patients with unevaluable or unknown response status will be considered nonresponders.

  Up to 8 weeks

Secondary Outcomes (8)

• ORR by immune-Modified Response Evaluation Criteria in Solid Tumors (iRECIST)

  Up to 8 weeks

• Progression free survival (PFS)

  Up to 36 months

• Overall survival (OS)

  Up to 36 months

• Determine local control in radiated lesion(s)

  Up to 36 months

• Tumor measurement change by RECIST or iRECIST

  Up to 8 weeks

Study Arms (1)

Radiation therapy (RT)

EXPERIMENTAL

Patients undergo radiation therapy for a total of 5 treatments over 5-9 calendar days in the absence of disease progression or unacceptable toxicity. Target prescription dose will be 30 Gy in 5 fractions and each treatment site (up to 5) will undergo standard Department-approved treatment planning, quality-assurance, and delivery protocols

Radiation: Radiation Therapy (RT)

Interventions

Radiation Therapy (RT) RADIATION

Undergo radiation therapy

Also known as: Cancer Radiotherapy, Irradiate, irradiated, Irradiation, RADIATION, Radiation Therapy, Radiation Therapy, Not otherwise specified, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

Radiation therapy (RT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a histologically, cytologically, or radiographically confirmed metastatic gastrointestinal (GI) malignancy (esophageal, gastroesophageal, gastric, small intestine, hepatocellular, pancreaticobiliary, colorectal, or anal cancer).
• Patients must be receiving immunotherapy (checkpoint inhibitor or CTLA4 inhibitor) with overall response of progressive disease by RECIST criteria.
• 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).
• 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
• Evaluation by a radiation oncologist within 28 days of study registration.
• Must have adequate organ function to administer radiation therapy and immunotherapy as per standard of care.
• Age \>= 18 years.
• Life expectancy exceeding 6 months.
• Eastern Cooperative Oncology Group (ECOG) 0-2 or Karnofsky performance status \>= 50.
• 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.
• a. If a woman is of child-bearing potential, a negative pregnancy test within 28 days prior to study enrollment is required.
• Ability to understand a written informed consent document, and the willingness to sign it.

You may not qualify if:

• Enrollment on immunotherapy clinical trial for which radiation therapy is not permitted.
• Administration of radiation therapy within 4 weeks prior to study enrollment.
• Treatment with systemic corticosteroids or other immunosuppressive medications which would significantly diminish the effect of immunotherapy as judged by the treating physician.
• Radiation therapy is contraindicated as adjudicated by the radiation oncologist.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Varian Medical Systems: collaborator

Study Sites (2)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

John Muir Medical Center-Walnut Creek

Walnut Creek, California, 94598, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus; Esophageal Squamous Cell Carcinoma; Stomach Neoplasms; Anal Canal Carcinoma; Colorectal Neoplasms; Esophageal Neoplasms; Carcinoma, Hepatocellular; Gastrointestinal Neoplasms; Anus Neoplasms

Interventions

Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Adenocarcinoma; Liver Neoplasms; Liver Diseases; Rectal Neoplasms; Anus Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Phenomena

Study Officials

• Mary Feng, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luchia Andemicael

CONTACT

(415) 530-9814; luchia.andemicael@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 9, 2020
• Study Start: August 7, 2020
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): April 30, 2028
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)