← Back to Search

Radiation Therapy

Stereotactic Body Radiotherapy for Non-Small Cell Lung Cancer (I-SABR Trial)

Phase 2

Waitlist Available

Research Sponsored by Crozer-Keystone Health System

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-24 months

Awards & highlights

I-SABR Trial Summary

This trial will test whether adding immunotherapy to a type of radiation therapy called SBRT can help treat metastatic NSCLC.

Eligible Conditions

Non-Small Cell Lung Cancer

I-SABR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acute Toxicity: Radiation pnuemonitis measured using NCI CTCAE version 4.0

Overall Survival

Secondary outcome measures

Impact of Tumor Burden

Late Toxicity: Pulmonary, Bone or Visceral organ toxicity evaluated 6 months from completion of treatment using NCI CTCAE version 4.

Local Control

+1 more

Side effects data

From 2008 Phase 2 trial • 20 Patients • NCT00350142

15%

ulcer

10%

vomiting

Perforation

pain

100%

80%

60%

40%

20%

Study treatment Arm

SBRT With Gem

I-SABR Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment ArmExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Body Radiotherapy

2017

Completed Phase 2

~220

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Saint Peter's University HospitalUNKNOWN

Crozer-Keystone Health SystemLead Sponsor

4 Previous Clinical Trials

291 Total Patients Enrolled

Saint Peters University HospitalOTHER

5 Previous Clinical Trials

4,056 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any evidence to suggest Stereotactic Body Radiotherapy may cause adverse effects in patients?

"Due to the lack of definitive data concerning effectiveness, Stereotactic Body Radiotherapy attained a rating of 2 for its safety profile."

Answered by AI

Are individuals being accepted to join this experiment at the present time?

"This particular medical investigation is not presently accepting new participants, as indicated by clinicaltrials.gov; it was initially posted on April 28th 2017 and had its most recent update on March 15th 2022. Despite this trial's inactivity, there are 2045 other trials that remain actively recruiting at the moment."

Answered by AI

What is the primary goal of this experiment?

"This clinical trial will last for a period of 24 months and its primary outcome is to measure acute toxicity: radiation pneumonitis, as evaluated through NCI CTCAE version 4.0. Secondary objectives include local control (from the time of enrolment until progressive disease at treatment site), late toxicity - pulmonary or bone fractures/visceral organ problems following SBRT 6 months post-treatment, and assessing the impact tumor burden has on overall survival rates and progression-free survivorship; patients are stratified based on their number of metastatic sites (<=3, 4-5, >5)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Immunotherapy SBRT Sensitization of the Programmed Death-1 (PD-1) Effect

Rachelle Lanciano M.D. 2017. "Immunotherapy SBRT Sensitization of the Programmed Death-1 (PD-1) Effect". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03825510.