NCT06712745 Feasibility Study of Personalized Ultra-fractionated Stereotactic Ablative Radiotherapy (PULSAR) for Cancers of the Central Lung
| NCT ID | NCT06712745 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | Cancer, Lung |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-09-19 |
| Primary Completion | 2028-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2025-09-19 with a primary completion date of 2028-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). Exclusion Criteria: 1. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields. 2. Plans for the patient to receive other local therapy in lung (including standard fractionated radiotherapy and/or surgery) while on this study, except at disease progression. 3. Females of reproductive potential who are not using an effective method of birth control and females who are pregnant or breastfeeding or have a positive (urine or serum) pregnancy test prior to study entry. 4. Prior administration of anti-VEGF (vascular endothelial growth factor) therapy within 1 year.
Contact & Investigator
KENNETH WESTOVER, MD, PhD
PRINCIPAL INVESTIGATOR
University of Texas Southwestern Medical Center
Frequently Asked Questions
Who can join the NCT06712745 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer, Lung. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06712745 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06712745 currently recruiting?
Yes, NCT06712745 is actively recruiting participants. Contact the research team at sarah.hardee@UTSouthwestern.edu for enrollment information.
Where is the NCT06712745 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT06712745 clinical trial?
NCT06712745 is sponsored by University of Texas Southwestern Medical Center. The principal investigator is KENNETH WESTOVER, MD, PhD at University of Texas Southwestern Medical Center. The trial plans to enroll 30 participants.
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