Phase II Trial of Regimen for Stage III (N2) NSCLC Using Induction Treatment Followed by Resection
ZTOG-1202
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
1 other identifier
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2013
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 4, 2013
CompletedFirst Posted
Study publicly available on registry
August 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedAugust 21, 2013
July 1, 2012
2.3 years
June 4, 2013
August 16, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PFS
up to 3 years
Secondary Outcomes (3)
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
QOL
up to 3 years
OS
up to 3 years
Study Arms (1)
Neoadjuvant Treatment
EXPERIMENTALNeoadjuvant Chemoradiotherapy
Interventions
Surgery followed by cisplatin-based regimen and concurrent radiation (46Gy/23f), consolidate the original regimen 2 cycles.
Eligibility Criteria
You may qualify if:
- ≤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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Weimin Mao, MD
Zhejiang Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2013
First Posted
August 21, 2013
Study Start
March 1, 2013
Primary Completion
June 1, 2015
Study Completion
June 1, 2016
Last Updated
August 21, 2013
Record last verified: 2012-07