Comparing surgery alone versus surgery with chemotherapy for early-stage lung cancer
A PHASE II STUDY Of ADJUVANT CHEMOTHERAPY After SURGERY For STAGE I Lung ADENOCARCINOMA PATIENTS With MICROPAPILLARY COMPONENT More Than Or EQUAL To 20%
PHASE2 · Shanghai Pulmonary Hospital, Shanghai, China · NCT03351842
This study is testing whether adding chemotherapy after surgery can help people with early-stage lung cancer live longer and stay cancer-free compared to just having surgery alone.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 460 (estimated) |
| Ages | 19 Years to 70 Years |
| Sex | All |
| Sponsor | Shanghai Pulmonary Hospital, Shanghai, China (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT03351842 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with completely resected stage I non-small cell lung cancer who have a micropapillary predominant component and meet specific health criteria.
Not a fit: Patients with prior chemotherapy or radiation treatment for non-small cell lung cancer, or those with other significant health issues, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with early-stage lung adenocarcinoma that has a micropapillary component, potentially improving survival rates.
How similar studies have performed: Other studies have indicated that chemotherapy can be effective for lung adenocarcinoma with micropapillary components, suggesting this approach may yield positive results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai
- Thoracic Surgery Department of Shanghai Pulmonary Hospital — Shanghai, China (RECRUITING)
Study contacts
- Study coordinator: Yingran Shen, PhD
- Email: elaineshen91@gmail.com
- Phone: 86-18117166317
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chemotherapy, Adjuvant, Lung Adenocarcinoma, Stage I, Treatment, Histological Type of Neoplasm, Adjuvant chemotherapy, Micropapillary Component, Early stage lung cancer