NCT04073745Active, not recruitingPhase 1
Single Fraction Stereotactic Body Radiation Therapy After Surgery in Treating Patients With Non-small Cell Lung Cancer
A Feasibility and Toxicity Analysis of Single Fraction Stereotactic Body Radiation Therapy for Post-Operative Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 24 Aug 2026
Brief summary (registry, in English)
This trial studies the side effects of single fraction stereotactic body radiation therapy after surgery in treating patients with non-small cell lung cancer. Standard radiation for lung cancer involves delivering small doses of daily radiation for several weeks. However, this technique has resulted in inferior outcomes compared to surgery and is associated with damage to surrounding normal lung. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. Giving stereotactic body radiation therapy in fewer treatment sessions (single fraction) may kill tumor cells and cause less damage to normal tissue.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 27 Aug 2019
- Start date
- 4 Dec 2019
- Primary completion date
- 11 Aug 2025
- Lead sponsor
- Roswell Park Cancer Institute
- Diseases
- Lung cancer
- NCT number
- NCT04073745
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 50
- From 4 Dec 2019 to the primary completion date, 11 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior radiation therapy targeting the same area for which radiation treatment is being planned
- Patients who undergo sublobar resection but are unable to undergo appropriate N1 and N2 lymph node sampling
Other illness
- Any condition which, in the investigator?s opinion, deems the patient unable to participate in enrollment
Other
- Contraindication to SBRT
- This includes the inability to cooperate with any aspect of SBRT such as the inability to lie still and breath reproducibly
- Pregnant or nursing female patients
- Unwilling or unable to follow protocol requirements
Who the study is looking for
- Have an Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
- Has completed curative-intent surgical resection of lung primary with pathologic diagnosis of NSCLC disease, with pathology to include at least 1 of the following:
- Close (\<=2 mm) or Positive surgical margin (R1/R2) or pathologic N2 disease (with or without extracapsular extension \[ECE\])
- Anatomic pulmonary resection (lobectomy or pneumonectomy) preferred, although sublobar resection is allowed at the discretion of the treating surgeon. Systemic lobe-specific nodal sampling is required. A minimum of 3 N2 stations must be sampled. Selective lymph node dissection should be completed for patients with known N2 disease
- Women of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence)
- Patient or legal representative must be willing and able to participate in protocol requirements, including pre- and post-treatment survey evaluations and clinical assessments
- Patient or legal representative 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Roswell Park Cancer Institute Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.