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

Phase 2

• Conditions: Non-small Cell Lung Cancer Stage IIIA
• Interventions: Other: Neoadjuvant Chemoradiotherapy

• Registration Number: NCT01926483
• Lead Sponsor: Zhejiang Cancer Hospital

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.

Study Timeline

• Status Verified: 2012-07
• Study Start: 2013-03
• Study First Submitted: 2013-06-04
• Study First Submitted QC: 2013-08-16
• Last Update Submitted: 2013-08-16
• Study First Posted: 2013-08-21
• Last Update Posted: 2013-08-21
• Primary Completion: 2015-06
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neoadjuvant Treatment	Neoadjuvant Chemoradiotherapy	Neoadjuvant Chemoradiotherapy

Primary Outcome Measures

Name	Time	Method
PFS	up to 3 years

Secondary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China