Phase 2 Completed N=98 Randomized Treatment

Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer

Lung Cancer

Source: ClinicalTrials.gov NCT00843726 ↗

Enrolled (actual)

Serious AEs

7.1%

Results posted

Jun 2021

Primary outcomePrimary: Incidence of AE Grade 3 or Higher Toxicity — 24; 26 Participants

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.

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	—	—

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

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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. Informational only — not medical advice.