← Back to Search

Radiation Therapy

Genomic-Guided RT for Lung Cancer

Phase < 1
Recruiting
Led By Thomas Dilling, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with surgery within 14 days should have recovered from all effects of the surgery and be cleared by their surgeon
Diagnosis of AJCC Stage 2 or Stage 3 unresectable NSCLC as determined by a multidisciplinary oncology team
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 2 years
Awards & highlights

Study Summary

This trial will explore if using DNA testing to tailor radiation and chemotherapy treatments can improve outcomes in lung cancer.

Who is the study for?
Adults diagnosed with stage II or III non-small cell lung cancer (NSCLC) who are in good physical condition (ECOG 0-1), have a life expectancy over 12 weeks, and can provide a fresh tumor biopsy. Prior treatments are allowed. Participants must not be pregnant, breastfeeding, or have had certain other cancers within the last two years. They should not be on immunosuppressive medications recently and must agree to use effective contraception.Check my eligibility
What is being tested?
The trial is testing personalized radiation therapy guided by genomic information alongside standard chemotherapy for patients with locally advanced NSCLC. The goal is to see if this tailored approach is feasible and beneficial compared to traditional methods.See study design
What are the potential side effects?
Potential side effects may include typical reactions from radiation such as skin irritation, fatigue, nausea, and inflammation of surrounding tissues; plus those from chemotherapy like hair loss, increased infection risk due to low blood counts, mouth sores, and potential organ damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have recovered from recent surgery and my surgeon has cleared me.
Select...
My lung cancer is at Stage 2 or 3 and cannot be removed by surgery.
Select...
My lung cancer type has been confirmed with a recent biopsy.
Select...
My kidney, liver, and blood tests are within normal ranges.
Select...
I am fully active or can carry out light work.
Select...
I am 18 years old or older.
Select...
I will use effective birth control during the study.
Select...
I have had previous treatments for my condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of Unacceptable Toxicity
Secondary outcome measures
Freedom from local regional progression (FFLRP)
Overall Survival (OS)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm C: unable to calculate RSIExperimental Treatment1 Intervention
Participants in will receive standard RT dose of 60Gy in 30 fractions targeting the primary tumor and any involved regional lymph nodes.
Group II: Arm B: RSI predicts dose > 60 GyExperimental Treatment1 Intervention
Participants will receive treatment with RxRSI guided boost to the primary tumor up to 81Gy (2.7Gy/fraction).
Group III: Arm A: RSI predicts dose ≤ 60 GyExperimental Treatment1 Intervention
Participants will receive standard RT dose of 60Gy in 30 fractions targeting the primary tumor and any involved regional lymph nodes.

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
540 Previous Clinical Trials
135,405 Total Patients Enrolled
Thomas Dilling, MDPrincipal InvestigatorMoffitt Cancer Center
Bradford A Perez, MDPrincipal InvestigatorMoffitt Cancer Center

Media Library

Genomically Guided Radiation Therapy (RT) (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05873439 — Phase < 1
Non-Small Cell Lung Cancer Research Study Groups: Arm A: RSI predicts dose ≤ 60 Gy, Arm B: RSI predicts dose > 60 Gy, Arm C: unable to calculate RSI
Non-Small Cell Lung Cancer Clinical Trial 2023: Genomically Guided Radiation Therapy (RT) Highlights & Side Effects. Trial Name: NCT05873439 — Phase < 1
Genomically Guided Radiation Therapy (RT) (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05873439 — Phase < 1

Frequently Asked Questions

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

Is this trial open to new volunteers?

"As per information available on clinicaltrials.gov, this medical research is presently in search of potential candidates. The trial was first published on May 8th 2023 and underwent its most recent edit a fortnight later."

Answered by AI

How many individuals are currently taking part in the experiment?

"Indeed, the information posted on clinicaltrials.gov corroborates that this medical trial is open to enrolment. It was initially created on May 8th 2023 and last amended on May 23rd of the same year. There are hopes to recruit 30 individuals at a single research site."

Answered by AI
~20 spots leftby Oct 2026