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

• Status: Recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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%.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
• Treatments: Carboplatin; Cisplatin; Pemetrexed

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.