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Recruiting EARLY_Phase 1 NCT06712745

Feasibility Study of Personalized Ultra-fractionated Stereotactic Ablative Radiotherapy (PULSAR) for Cancers of the Central Lung

Trial Parameters

Condition Cancer, Lung
Sponsor University of Texas Southwestern Medical Center
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 30
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-09-19
Completion 2028-12
Interventions
Personalized Ultra-fractionated stereotactic ablative radiotherapy (PULSAR)

Brief Summary

The objective of this study is to enhance the safety profile of SAbR in ultra-central tumors of the lung (primary or metastatic) without compromising its effectiveness.

Eligibility Criteria

Inclusion Criteria: 1. Age ≥ 18 years of age. 2. Histologically proven diagnosis of cancer. At a minimum, the lung tumor in consideration for treatment must be clinically judged as related to the biopsied site. 3. Stage: Tumor (ITV) 1.5 - 5 cm in maximum diameter. 4. Tumor entirely within the 2 cm "central zone" or within 1 cm of the mediastinum, esophagus or proximal bronchial tree by investigator assessment. 5. Zubrod/ECOG Performance Status 0-2 within 30 days prior to registration. 6. Ability to tolerate MRI. 7. All men, as well as women of child-bearing potential\* must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from the time of consent, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Note: A female of child-bearing potential is any woman (regard

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