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Radiation Therapy
Targeted Radiation Therapy for Lung Cancer
N/A
Recruiting
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to study end (up to 5 years)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Limited G3L Toxicity
Secondary outcome measures
Change in Neutrophil to Lymphocyte ratio (NLR)
Local Recurrence (LR)
Metastasis Free Survival (MFS)
+2 moreTrial 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
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
452 Previous Clinical Trials
91,355 Total Patients Enrolled
Neil Newman, MDPrincipal InvestigatorThe University of Texas Health Science Center - Mays Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not receiving the usual treatment for my chest condition.I have had radiation therapy to my chest area before.I can take care of myself and am up and about more than 50% of my waking hours.I have had chemotherapy for a different cancer, not the one I'm currently diagnosed with.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.My cancer has spread to more than two places outside my chest.I am over 18 years old.I have received radiation to ease symptoms for my current cancer.Your blood tests must show specific levels within a certain range.You have more than 500 white blood cells per milliliter of blood.Your hemoglobin level is higher than 8 grams per deciliter.I have had bone marrow disease or leukemia.My cancer has spread but is limited in number and I am planned for specific chest treatment.I am receiving immunotherapy alongside radiation therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Radiation Dose Limitations to VMAT
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.
How many individuals are participating in this clinical trial?
"Affirmative, according to the information posted on clinicaltrials.gov, this trial is actively recruiting patients and was first made available on September 29th 2022. The most recent update took place 3 days after its launch date with a target of 55 participants across two sites."
Answered by AI
Does this research endeavor have any available openings for participation?
"Affirmative. Clinicaltrials.gov data reveals that this study, which was originally uploaded on September 29th 2022, is actively recruiting patients. The trial seeks to enrol 55 individuals from two different sites of care."
Answered by AI
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