Phase II Trial of Regimen for Stage III (N2) NSCLC Using Induction Treatment Followed by Resection (ZTOG-1202)

University of Chinese Academy Sciences

Status and phase

Unknown

Phase 2

Conditions

Non-small Cell Lung Cancer Stage IIIA

Treatments

Other: Neoadjuvant Chemoradiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01926483

ZTOG-1202

Details and patient eligibility

About

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.

Full 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.

Enrollment

75 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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).