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

NCT06712745 | Recruiting Early Phase 1 DMC

• 1 other identifier: STU-2024-1215
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer, Lung; Metastasis

Keywords

lung; central lumg; cancer; metastasis; PULSAR; non small cell lung cancer; NSCLC

Outcome Measures

Primary Outcomes (1)

• Efficacy- Survivability and response

  Rates of overall response will be assessed by RECIST criteria.Efficacy will be compared between PULSAR and historical controls from HILUS using ANOVA and chi-square test. Kaplan-Meier methods will be used to estimate progression-free survival, time to subsequent SABR, overall survival, clinical benefit rate, time to treatment discontinuation, duration of response, and time to new metastases. Response duration will be summarized for patients who responded. Descriptive summary statistics such as median and interquartile range (25% and 75% percentiles) will be used.

  4 years

Secondary Outcomes (1)

• Change in Tumor Volume

  1 year

Other Outcomes (1)

• Dosimetry

  1 year

Study Arms (1)

Feasibility

EXPERIMENTAL

Patients treated with PULSAR will undergo treatment over a total duration of 2-5 months with 3-4 weeks between each fraction. PULSAR treatments completed within 6 months will be acceptable if treatment breaks are required. In the event of a complete response between fractions, remaining fractions will be withheld at the discretion of the treating physician. Treatment may also be terminated for selected grade 3 or higher AEs. Treatment may also be terminated for regional or systemic progression detected during the PULSAR treatment interval.

Radiation: Personalized Ultra-fractionated stereotactic ablative radiotherapy (PULSAR)

Interventions

Personalized Ultra-fractionated stereotactic ablative radiotherapy (PULSAR) RADIATION

Radiation Therapy Prescription Dose: A dose of 40-50 Gy in 5 fractions prescribed to the PTV will be used for all cases

Feasibility

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Zubrod/ECOG Performance Status 0-2 within 30 days prior to registration.
• Ability to tolerate MRI.
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Elekta Limited: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Neoplasm Metastasis; Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

DEAE-Dextran

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Dextrans; Glucans; Polysaccharides; Carbohydrates

Study Officials

• KENNETH WESTOVER, MD, PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SARAH NEUFELD, MS, MBA

CONTACT

214-645-8525; sarah.hardee@UTSouthwestern.edu

KENNETH WESTOVER, MD, PhD

CONTACT

214 645 0323; Kenneth.Westover@UTSouthwestern.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Study agent:Stereotactic ablative body radiation (SABR)

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 2, 2024
• Study Start: September 19, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 10, 2025

Record last verified: 2025-05

Locations

US (1)