Comparing surgery alone versus surgery with chemotherapy for early-stage lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II clinical trial aims to evaluate the effectiveness of adjuvant chemotherapy in addition to surgery for patients diagnosed with stage I lung adenocarcinoma that has a micropapillary component of 20% or more. Approximately 460 patients will be randomly assigned to either receive only surgical resection or to undergo surgery followed by platinum-based chemotherapy. The study will monitor disease-free survival and overall survival rates, comparing outcomes between the two groups using statistical methods. The goal is to determine if adding chemotherapy improves patient prognosis in this specific cancer subtype.

Why it matters

Who can join: the full rules

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.

Where it's running

• Thoracic Surgery Department of Shanghai Pulmonary Hospital
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Yingran Shen, PhD
• Email: elaineshen91@gmail.com
• Phone: 86-18117166317

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.