To Evaluate the Optimal Timing of Postoperative Radiotherapy in Patients With IIIA(N2) Non-Small Cell Lung Cancer

Sponsor
Shanghai Chest Hospital
Study ID
NCT02974426
Phase
PHASE3
Status
Terminated

Conditions

  • Non-small Cell Lung Cancer Stage IIIA
  • Radiotherapy

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • PORT-first — RADIATION
    PORT administered at the first day of adjuvant therapy, using 3- dimensional conformal or intensity-modulated radiation, total dose of 50.4 Gy, 1.8 Gy once daily over 5.5 weeks.
  • PORT-last — RADIATION
    PORT administered sequentially after participants received adjuvant chemotherapy for four cycles, using 3- dimensional conformal or intensity-modulated radiation, total dose of 50.4 Gy, 1.8 Gy once daily over 5.5 weeks.
  • Platinum-based two drug chemotherapy (cisplatin/carboplatin + vinorelbine or cisplatin/carboplatin + pemetrexed regimen) — DRUG
    Cisplatin/ carboplatin + vinorelbine regimen for squamous cell lung carcinoma Cisplatin/carboplatin + pemetrexed regimen for lung adenocarcinoma

Study Details

Rationale: Completely resected non-small cell lung cancer (NSCLC) patients with histologically confirmed N2 disease are a heterogeneous population. After complete resection and postoperative chemotherapy (POCT), 20%-40% of cases have a risk of locoregional recurrence (LRR). Postoperative radiation therapy (PORT) should be an integral component of the multidisciplinary treatment for patients with stage IIIA(N2) disease. Postoperative Radiotherapy (PORT)-first strategy may have an advantage of the early administration of locoregional therapy to the mediastinum, in which the tumor burden is presumed to be higher than that of systematic micrometastases. It is not yet known for subsets with specific prognostic factors that confer higher LRR risks, what is the optimal timing of PORT and how to integrate with POCT (in a sequential fashion or concurrent fashion) when PORT is considered for patients with completely resected stage IIIA(N2) NSCLC. Purpose: This randomized phase III trial is studying the optimal timing of PORT to evaluate whether the PORT-first strategy (PORT administered first with concurrent or subsequent POCT) may be more effective than the PORT-last strategy (PORT administered sequentially following POCT) in treating high risk of LRR patients with completely resected pathologic stage IIIA(N2) NSCLC.

Key Dates

Start date
Nov 30, 2016
Status verified
Jun 2024
Primary completion
Feb 29, 2024
Completion
Feb 29, 2024

Study Design

Enrollment
132 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (PORT-first strategy)
    Concurrent chemoradiotherapy + sequential chemotherapy or PORT + sequential chemotherapy: Participants in the Arm I will receive PORT at the first day of therapy. For lung adenocarcinoma, the first day of radiotherapy will be administered concurrently with chemotherapy (two cycles of chemotherapy given during radiotherapy); then continue to give two cycles of sequential chemotherapy. For squamous cell lung carcinoma, PORT will be administered first followed by subsequent four cycles of sequential chemotherapy.
  • Active Comparator: Arm II (PORT-last strategy)
    Four cycles of chemotherapy + sequential PORT: Participants in the Arm II will receive four cycles of adjuvant chemotherapy and after that, sequential PORT (50.4 Gy, 1.8 Gy once daily over 5.5 weeks) will be administered.

Primary Outcome Measure

Disease-free survival (DFS) [ Time Frame: 4 years ]

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