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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 belowSelect...
I have recovered from recent surgery and my surgeon has cleared me.
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My lung cancer is at Stage 2 or 3 and cannot be removed by surgery.
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My lung cancer type has been confirmed with a recent biopsy.
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My kidney, liver, and blood tests are within normal ranges.
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I am fully active or can carry out light work.
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I am 18 years old or older.
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I will use effective birth control during the study.
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I have had previous treatments for my condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2 years
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recovered from any major surgery or significant injury at least 14 days before starting the study drug.I have recovered from recent surgery and my surgeon has cleared me.I have cancer that has spread to my brain or the lining around my brain.I haven't taken strong immune-weakening medicines in the last 14 days, except for minor exceptions like nasal sprays or low-dose steroids.I have an autoimmune or inflammatory disorder but may still qualify under certain exceptions.My lung cancer is at Stage 2 or 3 and cannot be removed by surgery.I am not allergic to any of the drugs or their components used in this study.I haven't had any cancer, except for certain low-risk types, in the last 2 years.My lung cancer type has been confirmed with a recent biopsy.My kidney, liver, and blood tests are within normal ranges.I am fully active or can carry out light work.I am 18 years old or older.You are expected to live for more than 12 weeks.I am not pregnant or breastfeeding.I will use effective birth control during the study.I have had previous treatments for my condition.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: RSI predicts dose ≤ 60 Gy
- Group 2: Arm B: RSI predicts dose > 60 Gy
- Group 3: Arm C: unable to calculate RSI
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.
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
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