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Phase II Trial of Regimen for Stage III (N2) NSCLC Using Induction Treatment Followed by Resection
Conditions
Non-small Cell Lung Cancer Stage IIIA
Conditions: official terms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords
Stage IIIA-N2 NSCLC
Study Type
Interventional
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
Intervention
Name: Neoadjuvant Chemoradiotherapy
Type: Other
Overall Status
Recruiting
Summary
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
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.
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).
- 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).
Location
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Status: Recruiting
Contact: Xu Yaping - +0086-571-88122082 - xuyaping1207@gmail.com
Start Date
March 2013
Completion Date
June 2016
Sponsors
Zhejiang Cancer Hospital
Source
Zhejiang Cancer Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page