RTOG 0236
Stereotactic body radiation therapy for inoperable early stage lung cancer
Phase 2N = 59NCT00087438
- Population
- Patients aged 18 or older with biopsy-proven peripheral T1-T2N0M0 non-small cell lung cancer (tumour under 5 cm in diameter) and medical conditions precluding surgery.
- Design
- Phase 2 North American multicentre study with one prescribed regimen (no comparison group): stereotactic body radiotherapy 18 Gy per fraction in 3 fractions (54 Gy total) over 1.5 to 2 weeks. Opened 26 May 2004, closed 13 October 2006; data analysed through 31 August 2009. 59 patients accrued, 55 evaluable (44 with T1 and 11 with T2 tumours).
- Primary endpoint
- Primary tumour control
- Arms
- Stereotactic body radiotherapy (experimental, n = 59): SBRT 18 Gy per fraction x 3 fractions (54 Gy total) over 1.5 to 2 weeks
- People
- Timmerman R, Radiation Therapy Oncology Group
Show the numbers
| Endpoint | Analysis | Stereotactic body radiotherapy | Control | Effect |
|---|---|---|---|---|
| Primary tumour controlEvaluable patients (55) | primarymedian follow-up 34.4 monthsTimmerman 2010 | 97.6% at 3 y (84.3–99.7%) | — | One evaluable patient had a primary tumour failure. The primary end point was 2-year actuarial primary tumour control; the abstract and the full text report the 3-year estimate and give no 2-year value. |
| Primary tumour and involved-lobe controlEvaluable patients (55) | primarymedian follow-up 34.4 monthsTimmerman 2010 | 90.6% at 3 y (76.0–96.5%) | — | — |
| Local-regional controlEvaluable patients (55) | primarymedian follow-up 34.4 monthsTimmerman 2010 | 87.2% at 3 y (71.0–94.7%) | — | Three-year rate: the full text states 'the three year local-regional control rate was 87.2%'; the abstract does not repeat the time point. |
| Disseminated failureEvaluable patients (55) | primarymedian follow-up 34.4 monthsTimmerman 2010 | 22.1% at 3 y (12.3–37.8%) | — | — |
| DFSEvaluable patients (55) | primarymedian follow-up 34.4 monthsTimmerman 2010 | 48.3% at 3 y (34.4–60.8%) | — | Disease-free survival as defined in the abstract: primary tumour, involved lobe, regional and disseminated recurrence. A secondary end point of the study. |
| OSEvaluable patients (55) | primarymedian follow-up 34.4 monthsTimmerman 2010 | median 48.1 months; 55.8% at 3 y (41.6–67.9%) | — | Median overall survival 48.1 months with a 95% CI of 29.6 months to not reached (upper bound not reached, so it cannot be entered as a number). Follow-up range 4.8 to 49.9 months. A secondary end point of the study. |
| Treatment-related grade 3 adverse eventsEvaluable patients (55) | primaryTimmerman 2010 | 12.7% (9.6–15.8%) | — | Seven patients had protocol-specified treatment-related grade 3 adverse events. The 95% CI is entered as published. The abstract does not state the denominator; the full text table is headed 'All Patients (n=55)' (12.7% corresponds to 7 of 55 evaluable patients). Toxicity was a secondary end point. |
| Treatment-related grade 4 adverse eventsEvaluable patients (55) | primaryTimmerman 2010 | 3.6% (2.7–4.5%) | — | Two patients had grade 4 adverse events; no grade 5 events were reported. The 95% CI is entered as published. The abstract does not state the denominator; the full text table is headed 'All Patients (n=55)' (3.6% corresponds to 2 of 55 evaluable patients). Toxicity was a secondary end point. |
| Endpoint | Analysis | Stereotactic body radiotherapy | Control | Effect |
|---|---|---|---|---|
| Primary tumour controlEvaluable patients (55) | primarymedian follow-up 34.4 monthsTimmerman 2010 | 97.6% at 3 y (84.3–99.7%) | — | One evaluable patient had a primary tumour failure. The primary end point was 2-year actuarial primary tumour control; the abstract and the full text report the 3-year estimate and give no 2-year value. |
| Primary tumour and involved-lobe controlEvaluable patients (55) | primarymedian follow-up 34.4 monthsTimmerman 2010 | 90.6% at 3 y (76.0–96.5%) | — | — |
| Local-regional controlEvaluable patients (55) | primarymedian follow-up 34.4 monthsTimmerman 2010 | 87.2% at 3 y (71.0–94.7%) | — | Three-year rate: the full text states 'the three year local-regional control rate was 87.2%'; the abstract does not repeat the time point. |
| Disseminated failureEvaluable patients (55) | primarymedian follow-up 34.4 monthsTimmerman 2010 | 22.1% at 3 y (12.3–37.8%) | — | — |
| DFSEvaluable patients (55) | primarymedian follow-up 34.4 monthsTimmerman 2010 | 48.3% at 3 y (34.4–60.8%) | — | Disease-free survival as defined in the abstract: primary tumour, involved lobe, regional and disseminated recurrence. A secondary end point of the study. |
| OSEvaluable patients (55) | primarymedian follow-up 34.4 monthsTimmerman 2010 | median 48.1 months; 55.8% at 3 y (41.6–67.9%) | — | Median overall survival 48.1 months with a 95% CI of 29.6 months to not reached (upper bound not reached, so it cannot be entered as a number). Follow-up range 4.8 to 49.9 months. A secondary end point of the study. |
| Treatment-related grade 3 adverse eventsEvaluable patients (55) | primaryTimmerman 2010 | 12.7% (9.6–15.8%) | — | Seven patients had protocol-specified treatment-related grade 3 adverse events. The 95% CI is entered as published. The abstract does not state the denominator; the full text table is headed 'All Patients (n=55)' (12.7% corresponds to 7 of 55 evaluable patients). Toxicity was a secondary end point. |
| Treatment-related grade 4 adverse eventsEvaluable patients (55) | primaryTimmerman 2010 | 3.6% (2.7–4.5%) | — | Two patients had grade 4 adverse events; no grade 5 events were reported. The 95% CI is entered as published. The abstract does not state the denominator; the full text table is headed 'All Patients (n=55)' (3.6% corresponds to 2 of 55 evaluable patients). Toxicity was a secondary end point. |
- Stereotactic body radiotherapy (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Stereotactic body radiotherapy |
|---|---|
| 0 | 100.0% |
| 30 | 64.9% |
| 60 | 42.1% |
| 90 | 27.3% |
| 120 | 17.7% |