To Evaluate the Optimal Timing of Postoperative Radiotherapy in Patients With IIIA(N2) Non-Small Cell Lung Cancer
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Shanghai Chest Hospital
Collaborators:
Fudan University RenJi Hospital Ruijin Hospital Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Pulmonary Hospital, Shanghai, China Shanghai Zhongshan Hospital