Postoperative Radiotherapy for Patients With IIIA (N2) Non-small Cell Lung Cancer
Condition: Thoracic Neoplasms; Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Thoracic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Several important international randomized trials have shown that postoperative chemotherapy
      contributed to the improvement on 5 year survival rate by about 4% for patients with
      non-small cell lung cancer (NSCLC) after complete resection. But the overall survival rate
      was relatively low and the local recurrence was still the dominant failure pattern for stage
      IIIA (N2) disease even these patients received the postoperative chemotherapy. Several
      meta-analyses have shown that postoperative radiotherapy (PORT) has no effect on the survival
      improvement for patients with NSCLC after complete resection. However, sub-group analysis
      based on the same dataset of these meta-analyses showed that the PORT with conventional
      radiotherapy might be beneficial for stage IIIA (N2) disease. The 3D conform radiotherapy
      (3D-CRT) and intensity modified radiotherapy (IMRT) can increase the radiation dose to the
      target volume while decreasing the dose to risk organs comparing with the conventional
      radiotherapy. So it is expected that PORT using 3D-CRT or IMRT after postoperative
      chemotherapy will improve the local control and survival for stage IIIA (N2) NSCLC. Here, the
      investigators designed a phase III randomized trial to compare the 3-year disease free
      survival (DFS) and overall survival (OS) rates in patients with completely resected stage
      IIIA (N2) NSCLC who receive adjuvant chemotherapy alone or adjuvant chemotherapy plus PORT.
    

Detailed description: 
      OBJECTIVES:

      Primary: To determine whether administering adjuvant chemotherapy (four cycles of
      platinum-based doublet regimen) plus PORT (50 Gy, 2 Gy once daily over 5 weeks) will improve
      3-year DFS compared with adjuvant chemotherapy alone in patients with completely resected
      stage IIIA (N2) NSCLC.

      Secondary: To compare treatment-related toxic effects, 3-year OS, failure-free survival, and
      the patterns of failure.

      OUTLINE: Eligible patients were randomized equally, using simple randomization, to either
      PORT or observation group.

      Arm I: Patients undergo PORT using 3D-CRT or IMRT (50 Gy, 2 Gy once daily over 5 weeks) after
      adjuvant chemotherapy.

      Arm II: Patients undergo adjuvant chemotherapy.

      After completion of study treatment, patients are followed every 3 months for 1 year, every 6
      months for 2 years, and then annually thereafter.
    

Intervention name(s): Postoperative 3D-CRT or IMRT
Intervention type(s): Radiation
Intervention description(s): Postoperative radiotherapy using 3D-CRT or IMRT techniques, 2 Gy per fraction, total 25 fractions (50Gy) over 5 weeks.
Other intervention name(s): Postoperative radiotherapy
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lung; Carcinoma; radiotherapy; Surgery