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Radiation Therapy for the Treatment of Metastatic Gastrointestinal Cancers

ConditionsStage 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
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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 one metastasis which is progressing as per RECIST criteria.

Symptomatic disease causing pain, bleeding, dyspnea, dysphagia, or nausea

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Radiation Therapy (RT)

    Radiation

    Undergo radiation therapy

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: Radiation therapy (RT)Experimental treatment 1 intervention

Trial outcomes

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.

Time frame
Up to 8 weeks

Secondary outcomes

1

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

Will be determined by immune-Modified Response Evaluation Criteria in Solid Tumors (iRECIST). Immune Complete Response (iCR), Partial Response (iPR), or Stable Disease (iSD) per definitions of CR, PR, and SD, but occurring after initial immune unconfirmed progressive disease (iUPD). The same definition will be used for per lesion analysis. PD will be designated for all patients with PD determination by RECIST v1.1 or immune-confirmed progressive disease (iCPD) by iRECIST. Unconfirmed response for all patients designated as iUPD. Will be reported as proportion of response and corresponding exact confidence intervals. Patients with unevaluable or unknown response status will be considered nonresponders.

Time frame
Up to 8 weeks
2

Progression free survival (PFS)

PFS is defined as the duration of time from start of radiation treatment to time of progression or death a proportion with exact confidence intervals and will be reported for the entire cohort and stratified by histologic subtype, PD1/PDL1 status, MSI, and organs treated if sample size allows. Time to local progression will be described using the cumulative incidence method and comparisons between strata via Gray's test, if sample size allows; Otherwise, Kaplan-Meier methodology will be used and comparisons will be made via log-rank test; and Cox proportional hazards analysis, if possible.

Time frame
Up to 36 months
3

Overall survival (OS)

OS will be measured from the date of initiation of RT. OS is defined as the time from the date of initiation of RT to the date of death due to any cause. Censoring will be performed using the date of last known contact for those who are alive at the time of analysis. OS will be reported for the entire cohort and stratified by histologic subtype, PD1/PDL1 status, MSI, and organs treated if sample size allows.

Time frame
Up to 36 months
4

Determine local control in radiated lesion(s)

Local control will be defined as absence of per-lesion PD in an irradiated lesion (as defined above, a 20% increase in the longest diameter since the treatment started or a 5 mm increase over the nadir longest diameter from initiation of radiation therapy to time of progression of radiated lesion(s)

Time frame
Up to 36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

Varian Medical Systems

Collaborator

Source ClinicalTrials.gov
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