Personalized PULSAR MRI-guided radiation for central lung tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-arm, early-phase effort uses a 1.5T MR-guided linear accelerator (Unity, Elekta) with real-time motion monitoring to deliver personalized ultra-fractionated stereotactic ablative radiotherapy (PULSAR) to central lung tumors. Patients receive five high-precision fractions delivered one at a time every three weeks with MRI-guided adaptive planning before each session. The protocol aims to improve tumor visualization, reduce planning and motion margins, and permit normal tissue healing between widely spaced fractions to lower toxicity risk for ultra-central lesions. Eligible tumors are 1.5–5 cm and located within the central 2 cm zone or within 1 cm of the mediastinum, esophagus, or proximal bronchial tree, and patients must be able to tolerate MRI and have ECOG/Zubrod 0–2.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Texas Southwestern Medical Center
  Dallas, Texas, United States Recruiting

Study contacts

• Principal investigator: KENNETH WESTOVER, MD, PhD — University of Texas Southwestern Medical Center
• Study coordinator: Sarah Neufeld, Ms, Mba
• Email: sarah.hardee@UTSouthwestern.edu
• Phone: 214-645-8525

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.