RightFit
RecruitingPhase 2

Hotspot Stereotactic Ablative Radiotherapy Versus Traditional Stereotactic Ablative Radiotherapy for the Treatment of Early-Stage Non-Small Cell Lung Cancer

(PRESTO) A Randomized Phase II Trial Evaluating Hotspots in Stereotactic Ablative Radiotherapy for Early-Stage Non-Small Cell Lung Cancer

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

  • Time periods mentioned: 1 year
  • Procedures mentioned: Questionnaires

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
  • "Will evaluate for any potential interactions between quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer \[EORTC QLQ-LC13\]) and hotspot grouping."
  • "After completion of study treatment, patients are followed up every 3 months for 1 year and then every 3-6 months up to month 36."
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 compares two types of focused radiation treatment for adults with early-stage non-small cell lung cancer. One type adds “hot spots” that give the tumor more radiation than standard treatment. This may help control the tumor better, but may also cause more side effects.

This clinical trial compares stereotactic ablative radiotherapy (SBRT) with hot spots to standard of care SBRT for the treatment of patients with early-stage non-small cell lung cancer. SBRT with hot spots intentionally makes sure the tumor gets a higher radiation dose during treatment. This potentially may result in better control of the tumor, but also more side effects. SBRT with or without hot spots may be more effective in treating patients with early-stage non-small cell lung cancer, compared to standard of care SBRT.

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 age 18 or older.
  • You can care for yourself and are up and about for more than half of your waking hours.
  • You have T1–3N0 non-small cell lung cancer, with no spread to nearby lymph nodes. A tissue sample must confirm each tumor.
  • If you have a new lung tumor after past lung cancer, the earlier cancer must be controlled and have been treated more than 6 months before study treatment.
  • You can receive focused, high-dose radiation treatment called SABR or SBRT.
  • If you can become pregnant, you must agree to use birth control or avoid sex before joining. Tell your doctor right away if you become pregnant or think you may be pregnant during the study.
  • You must understand that this is a research study and sign a consent form before any study procedures.

Who can't join

  • You had treatment for a previous lung cancer within 6 months of study treatment, or your cancer has both small cell and non-small cell types.
  • You have had an organ transplant from another person or have a history of a disorder that weakens the immune system from birth.
  • You had radiation to an overlapping chest area that your doctor thinks would interfere with study treatment.
  • You have an active disease where the immune system attacks your body and needed whole-body treatment in the past 2 years. Replacement hormones, such as insulin or thyroid medicine, are allowed.
  • Your cancer has a known EGFR or ALK gene change.
  • You have a history of interstitial lung disease, which causes lung scarring or swelling, including cases caused by drugs; active signs of this disease; or lung swelling from radiation that needed steroid treatment.
  • You are pregnant or breastfeeding.
  • You are unwilling or unable to follow the study requirements.

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

Official eligibility criteria

Inclusion Criteria: * Age ≥ 18 years * Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 * Diagnosed with T1-3N0 biopsy-proven NSCLC of the lung. Multiple primary lung tumors are allowed; however, each lesion requires histologic confirmation * Metachronous lung tumors as defined as a new lung lesion in the setting of a historically treated lung cancer are allowed under certain conditions. The previous lung cancer must have been treated greater than 6 months prior to protocol therapy and this cancer must be considered controlled * Eligible for SABR * Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately * Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: * Patients with a history of a prior lung cancer will be excluded only if the previous treatment is within 6 months of the protocol therapy * Mixed small cell and non-small cell lung cancer * History of allogeneic organ transplantation * History of primary immunodeficiency * Patients must not have undergone prior radiation to overlapping regions of the chest that, in the opinion of the treatment physician, will interfere with protocol treatment * Active autoimmune disease that has required systemic treatment in the last 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed * Known EGFR or ALK mutation * Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD * Pregnant or nursing female participant * Unwilling or unable to follow protocol requirements

Study sites (1)

NY