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

Summary

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.

Conditions

• Non-small Cell Lung Cancer Stage IIIA
• Radiotherapy

Interventions

RADIATION

PORT-first

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.

RADIATION

PORT-last

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.

DRUG

Platinum-based two drug chemotherapy (cisplatin/carboplatin + vinorelbine or cisplatin/carboplatin + pemetrexed regimen)

Cisplatin/ carboplatin + vinorelbine regimen for squamous cell lung carcinoma Cisplatin/carboplatin + pemetrexed regimen for lung adenocarcinoma

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China

  collaborator OTHER

• Fudan University

  collaborator OTHER

• Shanghai Zhongshan Hospital

  collaborator OTHER

• Ruijin Hospital

  collaborator OTHER

• RenJi Hospital

  collaborator OTHER

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• Shanghai Chest Hospital

  lead OTHER

Principal Investigators

• Xiaolong Fu, MD · Shanghai Chest Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-11-30

Primary Completion

2024-02-29

Completion

2024-02-29

Countries

• China

Study Locations