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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am mostly self-sufficient and can carry out daily activities.
Select...
I am on immunotherapy but my cancer is still growing.
Select...
I am 18 years old or older.
Select...
My cancer is a type of GI cancer and has spread to other parts.
Select...
I experience pain, bleeding, or difficulty breathing or swallowing due to my condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (ORR)
Secondary outcome measures
Determine local control in radiated lesion(s)
Frequency of grade 3 or higher adverse events
Incidence of New metastatic lesions
+5 moreSide effects data
From 2022 Phase 2 trial • 10 Patients • NCT0336771570%
Lymphocyte Count Decreased
60%
Alanine Aminotransferase Increased
50%
Rash Maculopapular
50%
Anemia
40%
Aspartate Aminotransferase Increased
40%
Platelet Count Decreased
40%
Hyponatremia
30%
Diarrhea
30%
Serum Amylase Increased
30%
Confusion
30%
Fatigue
20%
Nausea
20%
Pyramidal Tract Syndrome
20%
Headache
20%
Lipase increased
20%
Paresthesia
20%
Generalized Muscle Weakness
20%
Insomnia
20%
Hypophosphatemia
20%
Chest Wall Pain
20%
Hyperglycemia
20%
Dizziness
20%
Seizure
20%
Creatinine Increased
10%
Restlessness
10%
Skin + Subcutaneous tissue disorder (foot ulcer)
10%
Localized Edema
10%
Conjunctivitis
10%
Encephalopathy
10%
Anxiety
10%
Blood lactate dehydrogenase increased
10%
Hypotension
10%
Fall
10%
Abdominal Pain
10%
Central Nervous System Necrosis
10%
Alkaline phosphatase increased
10%
Arthralgia
10%
Hypoglycemia
10%
Oculomotor nerve disorder
10%
Alopecia
10%
Bruising (Injection Site)
10%
Papulopustular Rash
10%
Hoarseness
10%
Hypermagnesemia
10%
Hyperkalemia
10%
Peripheral Sensory Neuropathy
10%
Productive Cough
10%
Rash Acneiform
10%
Agitation
10%
Pain
10%
Peripheral Motor Neuropathy
10%
Facial nerve disorder
10%
Sinus Bradycardia
10%
Hypomagnesemia
10%
Gastroesophageal reflux disease
10%
Flatulence
10%
Hypoalbuminemia
10%
Delirium
10%
Depression
10%
Dry eye
10%
Dry Mouth
10%
Lymphocyte count increased
10%
Nasal Congestion
10%
Somnolence
10%
Tremor
10%
Urinary tract infection
10%
Urinary urgency
10%
Watering Eyes
10%
Weight Loss
10%
White Blood Cell Decreased
10%
Dysarthria
10%
Dysgeusia
10%
Dysphagia
10%
Epistaxis
10%
Eye disorder, other; Diplopia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nivolumab + Ipilimumab + Short-course Radiation Therapy
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
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,505 Previous Clinical Trials
15,237,527 Total Patients Enrolled
Varian Medical SystemsIndustry Sponsor
58 Previous Clinical Trials
3,711 Total Patients Enrolled
Mary Feng, MDPrincipal InvestigatorUniversity of California, San Francisco
2 Previous Clinical Trials
44 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have seen a radiation oncologist within the last 28 days.I am mostly self-sufficient and can carry out daily activities.I have at least two growing cancer spots, and one can be left untreated safely.I am not on strong immune system-suppressing drugs that would affect immunotherapy.My doctor has determined that radiation therapy is not safe for me.I agree to use birth control during and after radiation therapy.I have 1-5 cancer sites needing radiation to ease symptoms, as confirmed by my radiation oncologist.I am on immunotherapy but my cancer is still growing.I am in a clinical trial for immunotherapy where radiation is not allowed.I am 18 years old or older.My cancer is a type of GI cancer and has spread to other parts.I experience pain, bleeding, or difficulty breathing or swallowing due to my condition.I have not had radiation therapy in the last 4 weeks.My organs are healthy enough for radiation and immunotherapy.I am a woman who can have children and have a recent negative pregnancy test.I am at risk for major organ or system problems.
Research Study Groups:
This trial has the following groups:- Group 1: Radiation therapy (RT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many subjects have enrolled in this clinical investigation?
"Absolutely, the information posted on clinicaltrials.gov indicates that this research is currently recruiting participants. The study was initially uploaded on August 7th 2020 and modified most recently in November 7th 2022. For now, 28 subjects are being recruited at a single site."
Answered by AI
Are new participants being sought out at this point in time for the clinical trial?
"Affirmative. Clinicaltrials.gov demonstrates that the search for participants is ongoing, beginning on August 7th 2020 and last updated on November 7th 2022. Altogether 28 people need to join from a single site."
Answered by AI
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