Phase II Trial of Regimen for Stage III (N2) NSCLC Using Induction Treatment Followed by Resection
Non-small Cell Lung Cancer Stage IIIA
Conditions: official terms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords
Study Type
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: Neoadjuvant Chemoradiotherapy
Type: Other
Overall Status
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.
Detailed Description

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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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).
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Status: Recruiting
Contact: Xu Yaping - +0086-571-88122082 -
Start Date
March 2013
Completion Date
June 2016
Zhejiang Cancer Hospital
Zhejiang Cancer Hospital
Record processing date processed this data on July 28, 2015 page