Genomically Guided Radiation Dose Personalization in Locally Advanced NSCLC
United States3 participantsStarted 2023-05-25
Plain-language summary
The purpose of the study is to determine the feasibility of genomically guided radiation therapy (RT) with concurrent chemotherapy in the management of stage II and III non-small cell lung cancer (NSCLC).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of AJCC Stage 2 or Stage 3 unresectable NSCLC as determined by a multidisciplinary oncology team
* Confirmation of NSCLC with availability of fresh tumor biopsy by tissue biopsy which can include adenocarcinoma, squamous cell, large cell carcinoma, or NSCLC not otherwise specified
* Life expectancy \>12 weeks
* Normal renal (creatinine \<1.5 × upper limit of normal \[ULN\]), liver (bilirubin \< 1.5 × ULN, transaminases \<3.0 × ULN, except in known hepatic disease, wherein may be \<5 × ULN) and blood counts (white blood cells ≥2.5, neutrophils ≥1000, platelets ≥50, 000, hemoglobin ≥8)
* ECOG 0-1
* Age ≥ 18 years
* Participants with surgery within 14 days should have recovered from all effects of the surgery and be cleared by their surgeon
* There is no limit on prior systemic or therapies
* Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study
* Ability to sign an informed consent form, which can be signed by a family member or health care proxy. Informed consent must be given before any study related procedures occur.
Exclusion Criteria:
* Current or prior participation in a study of an investigational agent or investigational device within 2 weeks of the first dose of study treatment
* Major surgery or significant traumatic injury that has not been recovered from 14 days before the initiation of study drug
* Women who are pregnant or breastfeeding
* History of allergy or h…
What they're measuring
1
Rate of Unacceptable Toxicity
Timeframe: 12 weeks after start of treatment
Trial details
NCT IDNCT05873439
SponsorH. Lee Moffitt Cancer Center and Research Institute