Description:
The purpose of this study is to evaluate the efficiency and safety of Gefitinib Neoadjuvant
Therapy and Oral Navelbine Carboplatin Neoadjuvant Therapy for Resectable Stage Ⅱ-ⅢA NSCLC
patients with EGFR mutation.
Title
- Brief Title: Clinical Trial of Neoadjuvant Targeted Treatment to NSCLC Patients
- Official Title: Oral Navelbine Carboplatin Versus Gefitinib Neoadjuvant Therapy for Resectable EGFR Mutation Positive Stage Ⅱ-ⅢA NSCLC, Prospective, Randomized, Multicenter, Phase Ⅲ Clinical Trial
Clinical Trial IDs
- ORG STUDY ID:
3939366
- NCT ID:
NCT03203590
Conditions
- 2-year Disease-Free Survival
Interventions
Drug | Synonyms | Arms |
---|
Oral Navelbine + Carboplatin | Vinorelbine, Carboplat | Oral Navelbine + Carboplatin |
Gefitinib | Iressa | Gefitinib |
Purpose
The purpose of this study is to evaluate the efficiency and safety of Gefitinib Neoadjuvant
Therapy and Oral Navelbine Carboplatin Neoadjuvant Therapy for Resectable Stage Ⅱ-ⅢA NSCLC
patients with EGFR mutation.
Detailed Description
Lung cancer is the most common cause of cancer mortality in men and women in the world. LACE
meta analysis shows that the 5-year survival rate of post-operation chemotherapy group rose
by 5.4%, therefore, adjuvant chemotherapy has been the main treatment after surgery according
to National Comprehensive Cancer Network (NCCN) Guideline. But patients have poor compliance
due to physical condition after surgery. Compared with adjuvant chemotherapy, neoadjuvant
therapy has better patient compliance and tolerance.Targeted therapy, with milder side effect
compared with chemotherapy, may be a promising choice to treat NSCLC previously. But to date,
there is no enough evidence to support the efficacy and safety of neoadjuvant targeted
therapy in patients with EGFR mutation.The purpose of this study is to evaluate the
efficiency and safety of Gefitinib Neoadjuvant Therapy vs Oral Navelbine Carboplatin
Neoadjuvant Therapy for Resectable NSCLC patients harboring EGFR mutation.
Trial Arms
Name | Type | Description | Interventions |
---|
Oral Navelbine + Carboplatin | Active Comparator | Neoadjuvant therapy Patients with EGFR mutation will be recruited and treated with Navelbine + Carboplatin. | - Oral Navelbine + Carboplatin
|
Gefitinib | Experimental | Neoadjuvant therapy Patients with EGFR mutation will be recruited and treated with gefitinib. | |
Eligibility Criteria
Inclusion Criteria:
- Pathologic diagnosis of non small cell lung cancer, Stage Ⅱ-ⅢA before treatment
- EGFR Gene mutated
- ECOG 0-1
- liver, kidney and bone marrow are functional healthy,WBC>4.0×109/L,PLT>100×109/L
Hb>10g/dL;Cr<1.8mg/dL,bilirubin<1.5mg/dL,GPT<1.5 upper limit of normal
- No vital systems dysfunction or malnutrition
- No other malignant diseases in 5 years(except non melanoma or Cervical carcinoma in
situ)
- Have never accepted radiation therapy、overall chemotherapy or biotherapy
- Know the whole protocol,Voluntary participate and sign a consent form
Exclusion Criteria:
- Tumor has violated the surrounding tissue organs(T4)
- Preoperative have evidence of distant metastasis including the contralateral
mediastinal lymph nodes
- Arrhythmia need anti-arrhythmic treatment(except for β-blockers or
digoxin),Symptomatic coronary artery disease and myocardial ischemia (myocardial
infarction) in the past 6 months or more than NYHA class II congestive heart failure
- Adverse drug control severe hypertension
- Moderate to severe proteinuria
- History of HIV infection or activity of chronic hepatitis b or hepatitis c, or other
active clinical severe infection
- Cachexy,organ function decompensation
- History of chest radiotherapy
- Not fully control the eye inflammation
- Epilepsy patients needed treatment(such as Steroids or antiepileptic cure)
- Interstitial pneumonia
- Drug abuse and medical, psychological or social conditions may interfere with the
patients involved in the research or have an impact on the results of evaluation
- Known or suspected to study drug allergy or to give any drug allergies associated with
this test
- Any unstable situation or may endanger the patient safety and compliance
- Fertility and pregnancy or lactation women, and have not been sufficient precautions
Maximum Eligible Age: | 70 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | 2-year disease free survival |
Time Frame: | 2 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Objective response rate |
Time Frame: | 1 week before surgery |
Safety Issue: | |
Description: | |
Measure: | Pathologic complete response |
Time Frame: | Within 1 month after surgery |
Safety Issue: | |
Description: | |
Measure: | Side effects |
Time Frame: | 1 week before surgery |
Safety Issue: | |
Description: | |
Measure: | Standard uptake value |
Time Frame: | 1 week before surgery |
Safety Issue: | |
Description: | |
Measure: | Tumor reduction rate |
Time Frame: | Within 1 month after surgery |
Safety Issue: | |
Description: | |
Measure: | Mediastinal lymph nodes clearance |
Time Frame: | Within 1 month after surgery |
Safety Issue: | |
Description: | |
Measure: | Postoperative complications |
Time Frame: | Within 1 month after discharge |
Safety Issue: | |
Description: | |
Measure: | R0 resection rate |
Time Frame: | Within 1 month after surgery |
Safety Issue: | |
Description: | |
Measure: | Postoperative mortality rate |
Time Frame: | Within 1 month after discharge |
Safety Issue: | |
Description: | |
Measure: | 5-year overall survival |
Time Frame: | 5 years after surgery |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Not yet recruiting |
Lead Sponsor: | Sun Yat-sen University |
Last Updated
June 29, 2017