Non-small Cell Lung Cancer Stage IIIA
Conditions
Keywords
Stage IIIA-N2 NSCLC
Brief 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.
Interventions
OTHERNeoadjuvant Chemoradiotherapy
Surgery followed by cisplatin-based regimen and concurrent radiation (46Gy/23f), consolidate the original regimen 2 cycles.
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS | up to 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 5 years | observe and record the toxicity profile(including but not limit to mucositis,liver and kidney function,et al.)according NCI-CTCAE(3rd edition) during the neoadjuvant chemoradiation and follow-up. |
| QOL | up to 3 years | — |
| OS | up to 3 years | — |
Countries
China
Contacts
Primary ContactWeiming Mao, MD
Backup ContactYaping Xu, MD
Outcome results
None listed