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

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · Nov 26, 2024

Keywords

ClinConnect Summary

The PULSAR clinical trial is looking into a new type of radiation treatment called personalized ultra-fractionated stereotactic ablative radiotherapy (SAbR) for lung cancer. This study aims to make the treatment safer for patients with tumors located in the central parts of the lung, whether these are primary tumors or metastases (cancers that have spread from other parts of the body). Although the trial is not yet recruiting participants, it is designed for adults aged 18 and older who have been diagnosed with lung cancer and have tumors of a specific size and location.

To be eligible for this study, participants must meet certain criteria, such as being able to tolerate MRI scans and having tumors within set size limits. Women who can become pregnant will need to use effective birth control during the trial and for a period afterward. Participants will receive treatment and will be closely monitored for safety and effectiveness. This trial is important because it could help improve treatment options for patients with challenging lung tumors while reducing potential side effects.

Gender

ALL

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.