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Trial Title:
Phase II Trial of Regimen for Stage III (N2) NSCLC Using Induction Treatment Followed by Resection
NCT ID:
NCT01926483
Condition:
Non-small Cell Lung Cancer Stage IIIA
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
Stage IIIA-N2 NSCLC
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Neoadjuvant Chemoradiotherapy
Description:
Surgery followed by cisplatin-based regimen and concurrent radiation (46Gy/23f),
consolidate the original regimen 2 cycles.
Arm group label:
Neoadjuvant Treatment
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.
Criteria for 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).
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Status:
Recruiting
Contact:
Last name:
Xu Yaping
Phone:
+0086-571-88122082
Email:
xuyaping1207@gmail.com
Start date:
March 2013
Completion date:
June 2016
Lead sponsor:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Source:
Zhejiang Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01926483
