RECRUITING

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

Conditions

Cancer, Lung Metastasis lung central lumg cancer PULSAR non small cell lung cancer NSCLC

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-10

Study Completion:2028-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06712745

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. * 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).	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.

Inclusion Criteria

Exclusion 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.
* 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).

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.

Contacts and Locations

Study Contact

SARAH NEUFELD, MS, MBA

CONTACT

214-645-8525

sarah.hardee@UTSouthwestern.edu

KENNETH WESTOVER, MD, PhD

CONTACT

214 645 0323

Kenneth.Westover@UTSouthwestern.edu

Principal Investigator

KENNETH WESTOVER, MD, PhD

PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Study Locations (Sites)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390

United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

KENNETH WESTOVER, MD, PhD, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-10

Study Completion Date2028-12

Study Record Updates

Study Start Date2025-10

Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Cancer, Lung
Metastasis