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Radiation Therapy

Radiation Therapy for Gastrointestinal Cancer

N/A

Recruiting

Led By Mary Feng, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) 0-2 or Karnofsky performance status >= 50.

Patients must be receiving immunotherapy (checkpoint inhibitor or CTLA4 inhibitor) with overall response of progressive disease by RECIST criteria.

Must not have

Radiation therapy is contraindicated as adjudicated by the radiation oncologist.

Enrollment on immunotherapy clinical trial for which radiation therapy is not permitted.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if radiation therapy can help treat gastrointestinal cancer that has spread to other parts of the body, in combination with immunotherapy.

Who is the study for?

This trial is for adults with metastatic gastrointestinal cancers, including esophageal and colorectal cancers, among others. Participants must have at least two progressing metastases, be on immunotherapy with worsening disease, and have a life expectancy over 6 months. They should not be pregnant or become pregnant during the trial and must use contraception.

What is being tested?

The study tests if radiation therapy can slow down or stop the growth of spreading gastrointestinal tumors in patients already receiving immunotherapy. It also explores whether radiating one tumor might activate the immune system to fight other non-radiated tumors.

What are the potential side effects?

Radiation therapy may cause side effects such as fatigue, skin changes at the treatment site, nausea, vomiting, diarrhea, pain or difficulty swallowing (for esophageal cancer), and potential damage to nearby organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am mostly self-sufficient and can carry out daily activities.

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I am on immunotherapy but my cancer is still growing.

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I am 18 years old or older.

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My cancer is a type of GI cancer and has spread to other parts.

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I experience pain, bleeding, or difficulty breathing or swallowing due to my condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My doctor has determined that radiation therapy is not safe for me.

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I am in a clinical trial for immunotherapy where radiation is not allowed.

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I have not had radiation therapy in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall response rate (ORR)

Secondary study objectives

Determine local control in radiated lesion(s)

Frequency of grade 3 or higher adverse events

Incidence of New metastatic lesions

+5 more

Side effects data

From 2022 Phase 2 trial • 10 Patients • NCT03367715

70%

Lymphocyte Count Decreased

60%

Alanine Aminotransferase Increased

50%

Anemia

50%

Rash Maculopapular

40%

Hyponatremia

40%

Aspartate Aminotransferase Increased

40%

Platelet Count Decreased

30%

Diarrhea

30%

Fatigue

30%

Confusion

30%

Serum Amylase Increased

20%

Dizziness

20%

Generalized Muscle Weakness

20%

Creatinine Increased

20%

Lipase increased

20%

Chest Wall Pain

20%

Headache

20%

Paresthesia

20%

Nausea

20%

Pyramidal Tract Syndrome

20%

Seizure

20%

Hyperglycemia

20%

Insomnia

20%

Hypophosphatemia

10%

Alkaline phosphatase increased

10%

Depression

10%

Dry Mouth

10%

Encephalopathy

10%

Anxiety

10%

Hoarseness

10%

Delirium

10%

Abdominal Pain

10%

Agitation

10%

Blood lactate dehydrogenase increased

10%

Central Nervous System Necrosis

10%

Bruising (Injection Site)

10%

Dry eye

10%

Peripheral Sensory Neuropathy

10%

Sinus Bradycardia

10%

Alopecia

10%

Arthralgia

10%

Conjunctivitis

10%

Flatulence

10%

Hyperkalemia

10%

Restlessness

10%

Hypotension

10%

Papulopustular Rash

10%

Productive Cough

10%

Facial nerve disorder

10%

Fall

10%

Lymphocyte count increased

10%

Peripheral Motor Neuropathy

10%

Skin + Subcutaneous tissue disorder (foot ulcer)

10%

Gastroesophageal reflux disease

10%

Hypoglycemia

10%

Hypomagnesemia

10%

Oculomotor nerve disorder

10%

Pain

10%

Hypermagnesemia

10%

Hypoalbuminemia

10%

Localized Edema

10%

Tremor

10%

Weight Loss

10%

Nasal Congestion

10%

Rash Acneiform

10%

Urinary tract infection

10%

Somnolence

10%

White Blood Cell Decreased

10%

Urinary urgency

10%

Watering Eyes

10%

Dysarthria

10%

Dysgeusia

10%

Dysphagia

10%

Epistaxis

10%

Eye disorder, other; Diplopia

100%

80%

60%

40%

20%

Study treatment Arm

Nivolumab + Ipilimumab + Short-course Radiation Therapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Radiation therapy (RT)Experimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy (RT)

2008

Completed Phase 2

~230

0 / 8Eligibility criteria met