Feasibility Study of Personalized Ultra-fractionated Stereotactic Ablative Radiotherapy (PULSAR) for Cancers of the Central Lung
Recruiting · NCT06712745 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Personalized Ultra-fractionated stereotactic ablative radiotherapy (PULSAR)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Early Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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).
Exclusion criteria
- 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.
Where it is running
1 location listed across 1 US state.
- University of Texas Southwestern Medical Center - Dallas, Texas, United States