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Radiation Therapy
SBRT Guided by PET Scans for Non-Small Cell Lung Cancer
Phase 2
Recruiting
Led By Arya Amini
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically confirmed NSCLC with 1-5 sites of disease progression while on or following systemic therapy with a checkpoint inhibitor with or without chemotherapy for at least 3 months with radiographic evidence of progression based on Response Evaluation Criteria in Solid Tumors (RECIST) or Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST)
Age: >= 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3, 6, and 12 months following radiation therapy
Awards & highlights
Study Summary
This trial tests the use of PET scans to guide SBRT to treat NSCLC, melanoma, and RCC with fewer doses and less damage to normal tissue.
Who is the study for?
This trial is for adults with certain cancers (NSCLC, melanoma, RCC) that have spread to up to 5 places. Patients must have had prior treatment and controlled primary tumor for over 3 months or be treated with intent to control. They need a life expectancy of at least 3 months and be able to undergo PET/CT scans.Check my eligibility
What is being tested?
The trial tests PET-guided SBRT's safety and effectiveness in treating oligoprogressive cancer compared to standard SBRT. It aims to deliver precise radiation doses while minimizing damage to healthy tissue by using advanced imaging techniques.See study design
What are the potential side effects?
Potential side effects include skin reactions, fatigue, inflammation of organs near the treated area due to radiation exposure, and possible changes in blood counts. The exact side effects will depend on the individual's response and the areas being treated.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My NSCLC has worsened on treatment, confirmed by tests.
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I am 18 years old or older.
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I can take care of myself and am up and about more than 50% of my waking hours.
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I have a cancer lesion that will receive a lower radiation dose to protect nearby organs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 3, 6, and 12 months following radiation therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3, 6, and 12 months following radiation therapy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility and safety of positron emission tomography (PET) adaptive stereotactic body radiation therapy (SBRT)
Secondary outcome measures
Dose delivered
Incidence of adverse events
Local control rates
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: ARM II: (PET guided SBRT)Experimental Treatment5 Interventions
ARM II: Patients undergo 3 SBRT treatments every other day week 1, undergo PET/CT and replanning one month post SBRT, then undergo 2 additional treatments with SIB on study. Patients also undergo CT or PET/CT and blood collection throughout study.
Group II: ARM I: (standard care SBRT)Experimental Treatment5 Interventions
Patients undergo 5 SBRT treatments every other day on study. Patients also undergo CT or PET/CT and blood collection throughout study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Biospecimen Collection
2004
Completed Phase 2
~1700
Computed Tomography
2017
Completed Phase 2
~2720
Positron Emission Tomography
2008
Completed Phase 2
~2240
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
567 Previous Clinical Trials
1,922,628 Total Patients Enrolled
2 Trials studying Melanoma
11 Patients Enrolled for Melanoma
National Cancer Institute (NCI)NIH
13,669 Previous Clinical Trials
40,926,369 Total Patients Enrolled
557 Trials studying Melanoma
193,158 Patients Enrolled for Melanoma
Arya AminiPrincipal InvestigatorCity of Hope Medical Center
5 Previous Clinical Trials
286 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- A radiation oncologist determined I can't have SBRT.My cancer spots can be treated with focused radiation and are at least 1 cm big.I am not pregnant or breastfeeding and have a negative pregnancy test.My NSCLC has worsened on treatment, confirmed by tests.I cannot have a PET/CT scan or my disease does not show up on PET scans.My brain metastases have been treated and are stable.My primary cancer has been stable for more than 3 months, or it's being treated with the goal of cure.I can have other treatments for my cancer, but one lesion must be treated with SBRT.Doctors believe you will live for at least 3 more months.I am 18 years old or older.I can take care of myself and am up and about more than 50% of my waking hours.I have a cancer lesion that will receive a lower radiation dose to protect nearby organs.
Research Study Groups:
This trial has the following groups:- Group 1: ARM I: (standard care SBRT)
- Group 2: ARM II: (PET guided SBRT)
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.
Are there any openings available for enrolment in this clinical trial?
"Based on the information displayed on clinicaltrials.gov, this trial has concluded its patient recruitment period and is no longer actively seeking participants. First posted on September 19th 2023 and last updated April 13th 2023, this research project has transitioned to a data collection phase even though 4600 other trials are currently searching for volunteers."
Answered by AI
Is the SBRT (standard care Stereotactic Body Radiation Therapy) protocol accepted by the FDA?
"Due to the Phase 2 status of ARM I: (standard care SBRT), there is evidence pointing towards a certain degree of safety yet no clinical data indicating efficacy. For this reason, our team at Power has assessed its risk level as a 2 on a scale from 1-3."
Answered by AI
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