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Alkylating agents
radiation therapy for Non-Small Cell Lung Cancer
Phase 1
Waitlist Available
Led By Kristin Higgins, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical stage Tx, T1-T4, N1-3, M0
If the primary tumor is central in location, defined as within 2 cm from the tracheobronchial tree, it must be no larger than 5 cm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 5 years
Awards & highlights
Study Summary
This trial is testing if SBRT can be safely given to patients with advanced lung cancer.
Eligible Conditions
- Non-Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acute toxicities associated with this regimen using CTCAE v.4
Late toxicities associated with this regimen using CTCAE v.4
Maximum tolerated dose (MTD) defined to be the dose level that results in a probability equal to 0.33 that a dose limiting toxicity (DLT) will be manifest using Common Terminology Criteria for Adverse Events (CTCAE) version 4 (v.4)
Secondary outcome measures
Distant metastasis
Local control
Overall survival
+1 moreSide effects data
From 2018 Phase 3 trial • 2028 Patients • NCT0000259744%
Acute RT Toxicity: Bowel: NOS
29%
Hormone Toxicity: Hot flashes : NOS
26%
Late RT Toxicity: Bowel: NOS
24%
Hormone Toxicity: Impotence : NOS
18%
Late RT Toxicity: Bladder: NOS
17%
Hormone Toxicity: Hematologic : NOS
15%
Acute RT Toxicity: Bladder: NOS
13%
Acute RT Toxicity: Hematologic: NOS
13%
Late RT Toxicity: Hematologic: NOS
13%
Acute RT Toxicity: Other: NOS
9%
Hormone Toxicity: Liver : NOS
8%
Late RT Toxicity: Other: NOS
7%
Late RT Toxicity: Other GU: NOS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Neoadjuvant TAS 2 Months Before and During RT
Radiation Therapy Alone
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (radiation therapy, carboplatin, paclitaxel, SBRT)Experimental Treatment4 Interventions
Patients undergo radiation therapy daily and receive carboplatin and paclitaxel weekly for 4.5 weeks. Patients then undergo 2 boost SBRT treatments 2-3 days apart.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
radiation therapy
1994
Completed Phase 3
~13390
stereotactic body radiation therapy
2019
Completed Phase 2
~480
Carboplatin
FDA approved
Paclitaxel
FDA approved
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,627 Previous Clinical Trials
2,560,749 Total Patients Enrolled
Washington University Siteman Cancer CenterOTHER
2 Previous Clinical Trials
69 Total Patients Enrolled
Kristin Higgins, MDPrincipal InvestigatorEmory University
4 Previous Clinical Trials
95 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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