| Methods |
Randomised controlled trial (1994‐2001) |
| Participants |
Individuals with stage IIIA pathologically confirmed N2 non‐small cell lung cancer. Patients with performance status 0‐1 were eligible if resection was technically feasible at randomisation |
| Interventions |
All patients first received induction chemotherapy consisting of cisplatin 50mg/m2 d1,8 and etoposide 50 mg/m2 d1‐5(PE) X2 and daily radiotherapy to 45 Gy starting day 1. After induction, individuals were treated according to the following: Intervention group: underwent resection if no progression, followed by PE X2; Control group: received uninterrupted radiotherapy to 61 Gy and PE X2 |
| Outcomes |
Toxicity, morbidity and mortality associated with treatment. Progression‐free and overall survival |
| Notes |
C factor was C3 ‐ all patients had CT scan chest and had mediastinoscopy and biopsy to confirm N2 status and exclude N3 disease (if contralateral nodes were present) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
Computer generated |
| Allocation concealment? |
Low risk |
Random allocation schedule generated at the Radiation Therapy Oncology Group statistical centre |
| Blinding?
All outcomes |
Unclear risk |
Information not reported |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Description of withdrawals and follow up was incomplete. Median follow up for all patients was 22.5 months (range 0.9 to 125.1) and for those still alive at the final analysis was 69.3 months (6.2 to 125.1). Only 92% of patients randomised were eligible for the analysis, mainly due to factors such as wrong stage or incomplete staging. |
