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

Zhejiang Cancer Hospital1 site in 1 country75 target enrollmentMarch 2013

ConditionsNon-small Cell Lung Cancer Stage IIIA

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Non-small Cell Lung Cancer Stage IIIA
Sponsor: Zhejiang Cancer Hospital
Enrollment: 75
Locations: 1
Primary Endpoint: PFS
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2013

End Date

June 2016

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Zhejiang Cancer Hospital

Responsible Party

Sponsor

Eligibility 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).

Outcomes

Primary Outcomes

PFS

Time Frame: up to 3 years

Secondary Outcomes

QOL(up to 3 years)
OS(up to 3 years)
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)