RightFit
RecruitingEarly Phase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests PULSAR, a personalized type of focused radiation treatment, for tumors near the center of the lungs. It aims to make treatment safer without making it less effective. It is for adults with cancer that started in the lung or spread there from another part of the body.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • A biopsy (test of a tissue sample) has confirmed cancer. The study doctor must judge that the lung tumor is related to that cancer.
  • The tumor measures 1.5 to 5 centimeters across at its widest point.
  • The tumor is fully within the lung’s 2-centimeter central zone, or within 1 centimeter of the space between the lungs, the food pipe, or the main airways.
  • Within 30 days before signing up, you must have an activity score of 0–2: you can walk and care for yourself, though you may not be able to work.
  • You can tolerate an MRI scan.
  • All men and women who could become pregnant must agree to use birth control or avoid sex from consent through 90 days after treatment ends. Tell your doctor right away if you become pregnant or think you may be pregnant.

Who can't join

  • You had radiation in the same area that would overlap with the study treatment.
  • You plan to have another treatment aimed at the lung tumor, such as radiation or surgery, during the study, unless the cancer gets worse.
  • You could become pregnant and are not using effective birth control, or you are pregnant, breastfeeding, or have a positive pregnancy test before joining.
  • You received anti-VEGF treatment (a drug that blocks blood vessel growth) within the past year.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

TX