Status:
UNKNOWN
Multicenter Randomized Controlled Trial Adjuvant Chemotherapy vs Observation in pStage Ib Lung Adenocarcinoma
Lead Sponsor:
Seoul National University Hospital
Conditions:
Stage Ib Lung Carcinoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Researchers developed the nomogram which evaluate the risk of recurrence after surgical resection, and found that the stage 1 NSCLC patients with more than 104 point of nomogram showed similar recurre...
Detailed Description
Enrolled stage 1B adenocarcinoma patient will be registered for the study and be randomly allocated to the treatment group and the observation group by the stratification factor; the institution. Each...
Eligibility Criteria
Inclusion
- Patients must meet ALL of the following criteria in order to be eligible for this study
- Age ≥18 years and Age \<80
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- The pathological stage Ib adenocarcinoma after complete resection (AJCC 7th). (Patients with adenocarcinoma in situ are excluded)
- Patients must have undergone pulmonary resection more than lobectomy (lobectomy, bilobectomy, pneumonectomy).
- Patients must have undergone either mediastinal lymph node dissection or systemic sampling.
- Tumor must be resected completely without gross or microscopic residual tumor.
- The interval between surgery for lung cancer and randomization must be no more than 8 weeks.
- The patients must be willing and sign informed consent prior to randomization.
- Patients with appropriate bone marrow function. ANC ≥1,500/uL, hemoglobin ≥9.0g/dL (can be corrected by transfusion). platelet ≥100,000/uL
- Patients with appropriate renal function Serum creatinine ≤ 1 x UNL(upper limit or normal) or Estimated creatinine clearance ≥ 45 ml/min
- Patients with appropriate liver function Serum bilirubin ≤ 1.5 x UNL, AST (SGOT) and ALT (SGPT) ≤ 3 x UNL, alkaline phosphatase ≤ 3 x UNL
Exclusion
- Patients meeting any ONE of the following criteria are not eligible for this study.
- Other concurrent serious diseases that may interfere with planned treatment.
- Pregnant of lactation women
- Women of childbearing potential without a negative pregnant test (urine HCG), within 14 days prior to randomization or less than one year after menopause.
- Any previous systemic chemotherapy for cancer or anti-cancer immunotherapy.
- History of non-lung malignancies within the 5 years prior to study entry, except for the following: carcinoma in situ of the cervix, melanoma in situ.
- Serious cardiac illness or medical conditions including uncontrolled hypertension, myocardial infarction within 6 months, unstable angina pectoris, heart failure \>NYHA grad II, or uncontrolled arrhythmia.
- Patients with sensitivity to vinorelbine or cisplatin.
- Any psychiatric or cognitive disorder that would limit the understanding or rendering of informed consent and/or compromise compliance with the requirements of this protocol.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2020
Estimated Enrollment :
1012 Patients enrolled
Trial Details
Trial ID
NCT02281708
Start Date
October 1 2014
End Date
September 1 2020
Last Update
November 3 2014
Active Locations (1)
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1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 463-707