Back to resultsPhase II Trial of Regimen for Stage III (N2) NSCLC Using Induction Treatment Followed by Resection (ZTOG-1202)
Primary Purpose
Non-small Cell Lung Cancer Stage IIIA
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Neoadjuvant Chemoradiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer Stage IIIA focused on measuring Stage IIIA-N2 NSCLC
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).
Sites / Locations
- Zhejiang Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Neoadjuvant Treatment
Arm Description
Neoadjuvant Chemoradiotherapy
Outcomes
Primary Outcome Measures
PFS
Secondary Outcome Measures
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.
QOL
OS
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01926483
Brief Title
Phase II Trial of Regimen for Stage III (N2) NSCLC Using Induction Treatment Followed by Resection
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer Stage IIIA
Keywords
Stage IIIA-N2 NSCLC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neoadjuvant Treatment
Arm Type
Experimental
Arm Description
Neoadjuvant Chemoradiotherapy
Intervention Type
Other
Intervention Name(s)
Neoadjuvant Chemoradiotherapy
Intervention Description
Surgery followed by cisplatin-based regimen and concurrent radiation (46Gy/23f), consolidate the original regimen 2 cycles.
Primary Outcome Measure Information:
Title
PFS
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
Adverse events
Description
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.
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
Title
QOL
Time Frame
up to 3 years
Title
OS
Time Frame
up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weiming Mao, MD
Phone
+86-571-88122032
Email
maowmzj1218@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yaping Xu, MD
Phone
+86-571-88128168
Email
xuyaping1207@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weimin Mao, MD
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xu Yaping
Phone
+0086-571-88122082
Email
xuyaping1207@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Phase II Trial of Regimen for Stage III (N2) NSCLC Using Induction Treatment Followed by Resection
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