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

NCT ID: NCT06712745

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-19
• Study Completion Date: 2028-12-31

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.

Detailed Description

This will be achieved by demonstrating the feasibility of applying adaptive radiation therapy given in PULSAR fractionation and using a 1.5T MR-guided linac system with real-time motion monitoring (Unity, Elekta). The hypothesis is that safety can be improved through: (1) better visualization of tumors, leading to less uncertainty when delineating GTVs; (2) reduced margins for setup, motion, or other sources of uncertainty; and (3) improved normal tissue healing between radiation fractions. To achieve this, we propose a personalized ultrafractionated stereotactic adaptive radiotherapy (PULSAR) delivery schedule, administering 5 fractions total, given as one fraction every 3 weeks (Fig. 3) and using MRI-guided adaptive treatment planning.

This study is single arm in nature and in the feasibility phase

Conditions

Cancer, Lung; Metastasis

Keywords

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Feasibility

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.

Group Type: EXPERIMENTAL

Personalized Ultra-fractionated stereotactic ablative radiotherapy (PULSAR)

Intervention Type: RADIATION

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

Interventions

Personalized Ultra-fractionated stereotactic ablative radiotherapy (PULSAR)

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

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Elekta Limited

INDUSTRY

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Kenneth Westover

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

KENNETH WESTOVER, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

SARAH NEUFELD, MS, MBA

Role: CONTACT

Phone: 214-645-8525

Email: sarah.hardee@UTSouthwestern.edu

KENNETH WESTOVER, MD, PhD

Role: CONTACT

Phone: 214 645 0323

Email: Kenneth.Westover@UTSouthwestern.edu

Facility Contacts

SARAH NEUFELD SUPERVISOR OF CLINICAL RESEARCH, MS, MBA

Role: primary

Role: backup

Other Identifiers

STU-2024-1215

Identifier Type: -

Identifier Source: org_study_id