NCT03351842RecruitingPhase 2
Surgery With or Without Chemotherapy for Stage I NSCLC With Micropapillary Component ≥ 20%
A PHASE II STUDY Of ADJUVANT CHEMOTHERAPY After SURGERY For STAGE I Lung ADENOCARCINOMA PATIENTS With MICROPAPILLARY COMPONENT More Than Or EQUAL To 20%
Source: ClinicalTrials.gov · Last updated 19 Dec 2017 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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%.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 460 (estimated)
- First submitted
- 20 Nov 2017
- Start date
- 1 Sept 2017
- Primary completion date
- 1 Sept 2019
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Diseases
- Lung cancer
- NCT number
- NCT03351842
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 460
- From 1 Sept 2017 to the primary completion date, 1 Sept 2019
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Within the past January subjects received other drug trials
- The abuse of drugs or alcohol addicts.
Other illness
- Suffered from other malignancies in five years
- 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
- Patients with difficult to control bacterial, viral, fungal infections
- Having a personality or mental disorders, without civil capacity or restricted civil capacity.
Other
- Do not meet the inclusion criteria
- There is evidence of distant metastases
- Refuses or is unable to sign informed consent to participate in trials
- Being pregnant or lactating women.
Who the study is looking for
- 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)
Age in the registry: 19 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Thoracic Surgery Department of Shanghai Pulmonary Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
Related publications
- Adjuvant Chemotherapy for Resected Stage-IA Lung Adenocarcinoma With Micropapillary Histologic Pattern.Interdiscip Cardiovasc Thorac Surg · 2026 · PMID 42266006
This page is information, not medical advice. Discuss any trial with your doctor.