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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Texas Southwestern Medical Center

About this trial

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

Qualifiers

Age ≥ 18 years of age.

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.

Stage: Tumor (ITV) 1.5 - 5 cm in maximum diameter.

Tumor entirely within the 2 cm "central zone" or within 1 cm of the mediastinum, esophagus or proximal bronchial tree by investigator assessment.

Disqualifiers

Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.

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.

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.

Prior administration of anti-VEGF (vascular endothelial growth factor) therapy within 1 year.

Trial design

Treatments tested in this trial

  • Personalized Ultra-fractionated stereotactic ablative radiotherapy (PULSAR)

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators