Targeted Radiation Therapy for Lung Cancer

Recruiting at 1 trial location

Overseen by Neil Newman, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: The University of Texas Health Science Center at San Antonio

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to see whether designing radiation to spare the vertebral bone marrow can limit the rates of lymphopenia during standard of care chemoradiation therapy and in the time to count recovery in the ensuing weeks. Secondary endpoints will examine whether this leads to improved disease control whether this is predictive of improved clinical outcomes such as rates of local recurrence (LR), metastasis free survival (MFS), overall survival (OS), and progression free survival (PFS) which will be followed prospectively up to 5 years.

Research Team

Neil Newman, MD

Principal Investigator

The University of Texas Health Science Center - Mays Cancer Center

Eligibility Criteria

The VMAT trial is for adults over 18 with stage IIIA-IIIC non-small cell lung cancer (NSCLC) without prior thoracic radiation or chemotherapy for other diseases. They must have a certain level of blood cells and liver function, and be in fair to good physical condition. Those with limited metastatic disease may join, but not if they have widespread metastases, bone marrow disease, leukemia, or are receiving concurrent immunotherapy.

Inclusion Criteria

I can take care of myself and am up and about more than 50% of my waking hours.

Your AST and ALT levels are not more than 2.5 times the upper limit of normal.

My lung cancer is at stage IIIA-IIIC but has not spread to distant organs.

Exclusion Criteria

I am not receiving the usual treatment for my chest condition.

I have had radiation therapy to my chest area before.

I have had chemotherapy for a different cancer, not the one I'm currently diagnosed with.

Treatment Details

Interventions

• Evidence-based radiation dose limitation to the vertebral bone marrow (Radiation Therapy)

Trial Overview This study tests whether limiting radiation exposure to the vertebral bone marrow during chemoradiation therapy can reduce lymphopenia (low white blood cell count) and speed up recovery time. It also looks at long-term outcomes like local recurrence and overall survival for up to five years.

Participant Groups

Group I: Radiation Dose Limitations to VMAT Experimental Treatment 1 Intervention

Patients confirmed to have T1-T3 N1-N3 (Stage IIIA-IIIC) or select Stage IV primary adeno- or squamous cell-carcinoma of the lung will be treated per standard of care; concurrent chemoradiotherapy for 6 to 6.5 weeks, followed by consolidative immunotherapy. A CT simulation scan is obtained with the patient in the treatment position allowing the radiation oncologist to delineate intended tumor targets and organs at risk (OAR). Using specialized treatment planning software, a radiation plan is generated with the goal of maximizing tumor coverage with intended prescription dose and minimizing unintended radiation dose to OARs below established thresholds. The primary intervention of this trial will be sparing the thoracic bone marrow. This will be done by delineating the thoracic bone marrow on the CT simulation scan and applying vertebral marrow-specific OAR constraints during treatment planning to optimally spare radiation dose to this structure during treatment

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+