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

August 16, 2013 updated by: Zhejiang Cancer Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PFS
Time Frame: up to 3 years
up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 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.
participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 5 years
QOL
Time Frame: up to 3 years
up to 3 years
OS
Time Frame: up to 3 years
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Cancer Hospital

Investigators

  • Principal Investigator: Weimin Mao, MD, Zhejiang Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

June 4, 2013

First Submitted That Met QC Criteria

August 16, 2013

First Posted (Estimate)

August 21, 2013

Study Record Updates

Last Update Posted (Estimate)

August 21, 2013

Last Update Submitted That Met QC Criteria

August 16, 2013

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZTOG-1202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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