Non-small Cell Lung Cancer
Conditions
Keywords
Microscopic N2 Non-small Cell Lung Cancer, Paclitaxel, Carboplatin, Cisplatin
Brief summary
This study propose adjuvant concurrent chemoradiotherapy vs chemotherapy alone in completely resected microscopic N2 NSCLC
Detailed description
Approximately 15% of patients with non-small cell lung cancer are diagnosed with stage IIIA-N2 disease. However, this subgroup is heterogeneous, with lymph nodes that are only microscopically invaded to those that are radiologically visible with bulky ipsilateral mediastinal lymph node involvement. Surgical resection in selected patients results in 5-year survival rates of 7-24%. The standard treatment for locally advanced clinical N2 disease is definitive concurrent chemoradiotherapy or induction chemotherapy (± radiation) followed by operation. However, in some patients, N2 status could be confirmed only after curative operation without any evidence of N2 diseases through preoperative evaluation methods (CT, PET, mediastinoscopy). We usually define those N2 disease found only after curative operation as microscopic N2, and do adjuvant chemotherapy, radiotherapy or concurrent chemoradiotherapy. However, little data about the adjuvant therapy for completely resected N2 disease have been available, Hence, we propose a randomized phase II study of adjuvant concurrent chemoradiotherapy vs chemotherapy alone in completely resected microscopic N2 NSCLC.
Interventions
RADIATIONconcurrent chemoradiotherapy
weekly paclitaxel 50mg/m2 plus weekly cisplatin 25mg/m2 5times with concurrent radiotherapy (5000rad/25fx) for 5 weeks followed by 2 cycles of 3-weekly paclitaxel (175mg/m2) plus cisplatin 80mg/m2.
four cycles of 3-weekly paclitaxel (175mg/m2) and carboplatin (AUC5.5).
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed diagnosis of stage IIIA(N2) NSCLC that was completely resected by lobectomy, bilobectomy, pneumonectomy, or sleeve lobectomy through any incision (thoracoscopic or video-assisted thorascopic surgery approaches were acceptable) 2. Pathologic N2 disease (involvement of N2 nodes can only be determined at the time of surgical exploration or postoperative pathologic analysis) 3. Age ≥18years 4. No known residual disease (negative resection margin and no extracapsular invasion of lymph node metastasis) 5. ECOG performance status of 0 to 1 6. No previous chemotherapy or RT 7. Adequate organ function as evidenced by the following; Absolute neutrophil count \> 1.5 x 109/L; platelets \> 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT \< 5 UNL; creatinine clearance ≥ 50mL/min 8. Written informed consent form
Exclusion criteria
1. Patients with preoperative mediastinoscopic N2 positive disease 2. Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia 3. Patients with post-obstructive pneumonia or uncontrolled serious infection 4. Pregnant or nursing women ( Women of reproductive potential have to agree to use an effective contraceptive method) 5. Prior history of malignancy within 5 years from study entry except for a adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival | 36 months |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS) | 36 months |
| Pattern of relapse | 36 months |
| Toxicity profile | 36 months |
| Quality of life (QOL) | 36 months |
Countries
South Korea
Outcome results
None listed