Phase 2
N=98
Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00843726 ↗Enrolled (actual)
98
Serious AEs
7.1%
Results posted
Jun 2021
Primary outcome: Primary: Incidence of AE Grade 3 or Higher Toxicity — 24; 26 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Arm 1 stereotactic body radiation therapy (Radiation); Arm II stereotactic body radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Roswell Park Cancer Institute
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of AE Grade 3 or Higher Toxicity |
24; 26 | — |
| PRIMARY Overall Survival |
39.0; 38.3 | — |
| PRIMARY Correlation Between Blood and Serum Markers and Survival and Toxicity |
— | — |
Summary
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known which regimen of radiation therapy is more effective in treating patients with non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying the side effects of two radiation therapy regimens and to see how well they work in treating patients with stage I or stage II non-small cell lung cancer.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed non-small cell lung cancer
- T1-T2, N0 disease measuring ≤ 5 cm( T3 tumor based on chest wall involvement is Excluded)
- Surgically resectable primary disease, however patient evaluated by thoracic oncologist and deemed medically inoperable OR patient refuses surgical resection
- Age >= 18
Exclusion Criteria
- Prior thoracic radiation therapy
- T2 or T3 tumor greater than 5 cm or T3 tumor based on chest wall involvement
- Node positive or metastatic disease
- Tumor location within the zone of the proximal bronchial tree. The proximal bronchial tree is defined as the carina, right and left main bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, and right and left lower lobe bronchi. The zone of the proximal bronchial tree is defined as a volume 2cm in all directions around the proximal bronchial tree.
- No other conditions deemed by the PI or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy (e.g., unable to lie still and breathe reproducibly)
- Pregnant or unwilling to use adequate contraception
Data sourced from ClinicalTrials.gov (NCT00843726). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.