Actively Recruiting
Surgery With or Without Chemotherapy for Stage I NSCLC With Micropapillary Component ≥ 20%
Led by Shanghai Pulmonary Hospital, Shanghai, China · Updated on 2017-12-19
460
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Randomized phase II trial aims to compare surgery with or without adjuvant chemotherapy in treating patients who are pathologically diagnosed as stage I lung adenocarcinoma with micropapillary component no less than 20%.
CONDITIONS
Official Title
Surgery With or Without Chemotherapy for Stage I NSCLC With Micropapillary Component ≥ 20%
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Completely resected Stage I non-small cell lung cancer as defined by the International Staging System
- Pathologically confirmed stage I lung adenocarcinoma with micropapillary component of 20% or more
- Randomization within 4 weeks after surgery
- No prior chemotherapy or radiation for non-small cell lung cancer
- Performance status of 0 or 1
- Women must be non-pregnant and non-lactating
- Patients of childbearing potential must agree to use effective contraception during the study
- No history of previous or other concurrent malignancies except certain treated cancers or disease-free for five years
- Granulocytes count of at least 1,800/µl
- Platelet count of at least 100,000/µl
- Bilirubin less than 1.5 mg/dl
- AST (SGOT) less than 2 times the upper limit of normal
You will not qualify if you...
- Does not meet inclusion criteria
- Evidence of distant metastases
- History of other malignancies within five years
- Participation in other drug trials since January
- Serious allergies or inability to use folic acid, dexamethasone, or vitamin B12
- Severe lung or heart disease
- Refusal or inability to consent to participate
- Drug or alcohol abuse
- Difficult to control bacterial, viral, or fungal infections
- Personality or mental disorders with limited legal capacity
- Being pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Thoracic Surgery Department of Shanghai Pulmonary Hospital
Shanghai, China, 200000
Actively Recruiting
Research Team
Y
Yingran Shen, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here