Trial comparing treatments for Early Stage Lung Non-Small Cell Carcinoma
Official title Hotspot Stereotactic Ablative Radiotherapy Versus Traditional Stereotactic Ablative Radiotherapy for the Treatment of Early-Stage Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT07718672
What this study is testing
- What it's testing
- This study aims to find out if giving a higher radiation dose to the most active parts of the tumor controls the cancer better than standard treatment.
- Who it's for
- The study is looking for people with early-stage non-small cell lung cancer.
- What's involved
- Participants will receive stereotactic ablative radiotherapy (SBRT), a precise form of radiation, either with a higher dose to specific tumor areas or with the standard dose.
- Time commitment
- The source text does not specify the total duration or the number of visits required.
- Phase 2: a mid-size study of how well it works
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
- Eligible for SABR
You likely can't join if
- 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...
- Active autoimmune disease that has required systemic treatment in the last 2 years.
See the full eligibility 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.
- 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.
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Buffalo, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Buffalo, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.