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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Carboplatin; Cisplatin; Pemetrexed; Vinorelbine

Criteria

Inclusion Criteria:

• Male or female, aged 18 years to 75 years;

• Complete resection through a surgical procedure of lobectomy, sleeve lobectomy or bilobectomy with microscopically tumor-free resection margins and margin-negative resection of all gross disease; Has undergone systematic nodal assessment (lymph node dissection or sampling with a minimum of three N2 stations sampled or completely dissected, one of which must be the subcarinal station);

• Histologically proven lung adenocarcinoma or squamous cell lung carcinoma of stage pT1-3N2M0 (according to the TNM classification in the Union for International Cancer Control (UICC) 7th ed.);

• Determined as the postoperative high risk of locoregional recurrence;

• No documented metastases (M1) and/or invasion (T4) by the pretreatment examination or at the time of surgery;

• No prior neoadjuvant therapy (chemotherapy and/or RT);

• No prior adjuvant therapy (chemotherapy and/or RT);

• No severe perioperative complications and expected postoperative lifespan ≥4 months;

• ECOG Performance Status 0-1;

• Voluntarily participated in this study and signed the informed consent form by himself or his agent. Had good compliance with the study procedures, and can cooperate with the relevant examination, treatment and follow-up;

Exclusion Criteria:

• Histologically confirmed large cell carcinoma, adenosquamous carcinoma, sarcomatoid carcinomas, neuroendocrine tumors (small cell carcinoma, large cell neuroendocrine carcinoma, carcinoid tumors, etc.), salivary-gland type tumors, adenomas, papillomas, or other and unclassified carcinomas;

• Patients undergoing pneumonectomy;

• Diagnosed with other prior or concurrent malignancies (neoplasm) except for basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 years;

• Patients with severe postoperative complications; and time to beginning of the adjuvant therapy has been more than 2 months from the date of surgery;

• Patients with any severe or uncontrolled systematic disease including severe cardiovascular, liver, kidney, hematopoietic, metabolic disease, or uncontrolled active infection that would preclude study participation;

• Patients with positive mental disorder that would preclude study participation;

• Contradictory to chest radiotherapy;

• Pregnant or nursing women;

• Concurrent other anti-cancer treatment;

• Prior preoperative Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) treatment or other targeted therapy;