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

NCT ID: NCT01926483

Last Updated: 2013-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2016-06-30

Brief Summary

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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

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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.

Conditions

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Non-small Cell Lung Cancer Stage IIIA

Keywords

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Stage IIIA-N2 NSCLC

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Neoadjuvant Treatment

Neoadjuvant Chemoradiotherapy

Group Type EXPERIMENTAL

Neoadjuvant Chemoradiotherapy

Intervention Type OTHER

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

Interventions

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Neoadjuvant Chemoradiotherapy

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

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Weimin Mao, MD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Locations

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Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Weiming Mao, MD

Role: CONTACT

Phone: +86-571-88122032

Email: [email protected]

Yaping Xu, MD

Role: CONTACT

Phone: +86-571-88128168

Email: [email protected]

Facility Contacts

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Xu Yaping

Role: primary

Other Identifiers

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ZTOG-1202

Identifier Type: -

Identifier Source: org_study_id