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

Non-small Cell Lung Cancer Stage IIIA Clinical Trial

— ZTOG-1202  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01926483
• Other study ID #: ZTOG-1202
• Status: Recruiting
• Phase: Phase 2
• First received: June 4, 2013
• Last updated: August 16, 2013
• Start date: March 2013
• Est. completion date: June 2016

Study information

• Verified date: July 2012
• Source: Zhejiang Cancer Hospital
• Contact: Weiming Mao, MD
• Phone: +86-571-88122032
• Email: maowmzj1218[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: June 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer Stage IIIA

Intervention

Other:
• Neoadjuvant Chemoradiotherapy
Surgery followed by cisplatin-based regimen and concurrent radiation (46Gy/23f), consolidate the original regimen 2 cycles.

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS		up to 3 years	Yes
Secondary	Adverse events	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.	participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 5 years	Yes
Secondary	QOL		up to 3 years	Yes
Secondary	OS		up to 3 years	Yes