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Radiation Therapy

Targeted Radiation Therapy for Lung Cancer

N/A

Waitlist Available

Led By Neil Newman, MD

Research Sponsored by The University of Texas Health Science Center at San Antonio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) 0-2

Patients with AJCC (American Joint Committee on Cancer) 8 T1-T4, N1-N3, M0 stage IIIA-IIIC NSCLC (non small cell lung cancer)

Must not have

Patients not being treated with definitive standard of care to the chest

History of thoracic irradiation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to study end (up to 5 years)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a new type of radiation therapy can help cancer patients by limiting side effects and improve disease control.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, generally sparing the vertebral bone marrow aims to minimize damage to it which could otherwise lead to lower white blood cell counts increasing infection risk among other potential complications from standard radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am over 18 years old.

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My cancer has spread but is limited in number and I am planned for specific chest treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have had radiation therapy to my chest area before.

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My cancer has spread to more than two places outside my chest.

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

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I have received radiation to ease symptoms for my current cancer.

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I have had bone marrow disease or leukemia.

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I am receiving immunotherapy alongside radiation therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to study end (up to 5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to study end (up to 5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to study end (up to 5 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Limited G3L Toxicity

Secondary study objectives

Local Recurrence (LR)

Metastasis Free Survival (MFS)

Overall Survival (OS)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Radiation Dose Limitations to VMATExperimental Treatment1 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

0 / 11Eligibility criteria met