Surgery With or Without Chemotherapy for Stage I NSCLC With Micropapillary Component ≥ 20%

Launched by SHANGHAI PULMONARY HOSPITAL, SHANGHAI, CHINA · Nov 20, 2017

Keywords

ClinConnect Summary

This clinical trial is studying whether surgery alone or surgery followed by chemotherapy is more effective for patients with Stage I lung adenocarcinoma that has a specific type of cancer cell called "micropapillary" making up 20% or more of the tumor. The goal is to find out if adding chemotherapy after surgery can help improve outcomes for these patients.

To be eligible for this trial, participants must have had their lung cancer completely removed through surgery and must be diagnosed with the specific type of lung adenocarcinoma mentioned. They should not have received any prior chemotherapy or radiation for lung cancer and need to be in good overall health. Participants will be randomly assigned to either receive just surgery or surgery with chemotherapy, and they will be monitored closely throughout the study. It's important for potential participants to know that they cannot have other serious health conditions or recent cancers, and they must be willing to follow the study guidelines.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Completely resected Stage I NSCLC as defined by the International Staging System
• • Pathologically diagnosed Stage I micropapillary predominant lung adenocarcinoma
• • Patients must be randomized within 4 weeks from the date of 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 an effective form of contraception while on study
• • Patients must have no history of previous or concomitant malignancy, other than curatively treated carcinoma in situ of the cervix, or basal cell or squamous cell carcinoma of the skin, or surgically treated in situ carcinoma of the breast, or other cancer for which the patient has been disease free for five years
• • Granulocytes \>= 1,800/ul
• • Platelets \>= 100,000/ul
• • Bilirubin \< 1.5 mg/dl
• • SGOT(serum glutamic-oxaloacetic transaminase) (AST) \< 2.0 x ULN(upper limit of normal value)
• Exclusion Criteria:
• • Do not meet the inclusion criteria
• • There is evidence of distant metastases
• • Suffered from other malignancies in five years
• • Within the past January subjects received other drug trials
• • Having serious allergies or idiosyncratic persons, such as you can not use folic acid, dexamethasone, vitamin B12 patients
• • Severe lung or heart disease, a history
• • Refuses or is unable to sign informed consent to participate in trials
• • The abuse of drugs or alcohol addicts.
• • Patients with difficult to control bacterial, viral, fungal infections
• • Having a personality or mental disorders, without civil capacity or restricted civil capacity.
• • Being pregnant or lactating women.