Phase II Trial of Regimen for Stage III (N2) NSCLC Using Induction Treatment Followed by Resection

A Prospective, Phase II Trial of a Trimodality Regimen for Stage III (N2) Non-small-cell Lung Cancer Using Concurrent Chemoradiotherapy as Induction Treatment Followed by Subsequent Resection

The investigators hypothesized that the Neoadjuvant Chemoradiotherapy was a beneficial treatment for Patients with Stage IIIA-N2 Non-Small Cell Lung Cancer, so we try to evaluate the security of treatment, the QoL of patients and the influence to the PFS and OS.

Scheme:

Patients will receive different chemotherapy regimens depending on the pathological type.

Squamous cell carcinoma:Docetaxel/Cisplatin and concurrent radiation (46Gy/23f) followed by surgery, consolidate Docetaxel/Cisplatin 2 cycles.

Non-squamous cell carcinoma:Pemetrexed/Cisplatin and concurrent radiation (46Gy/23f) followed by surgery, consolidate Pemetrexed/Cisplatin 2 cycles.

Inclusion Criteria:

• 18≤Age≤65;
• ECOG performance status of 0 or 1;
• Pathological diagnosis with Stage IIIA-N2 NSCLC which is clinically resectable and the N2 is diagnosed by either mediastinoscopy,EBUS,PET/CT;
• WBC≥4.0×109/l, ANC≥1.5×109/l, PLT≥100.0×109/l, Hb≥90g/l;hepatorenal function is normal;
• Without a history of other malignancies before enrollment, except for non-melanoma skin cancer, in situ cervical cancer;
• The patient can understand the research and sign the informed consent.

Exclusion Criteria:

• Female in pregnancy or lactating;Female of childbearing age without contraception;
• With acute infection or other serious underlying disease;
• With a significant history of neurological of psychiatric disease，including the dementia which may affect the ability to understand and sign the informed consent;
• Have received other treatment within the last 30 days before enrollment;
• With uncontrollable diabetes(blood glucose is unstable after treatment or FBG≥8mol/L).