Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatments concurrent chemoradiotherapy, chemotherapy only
Phase phase 2
Sponsor Samsung Medical Center
Start date April 2009
End date March 2014
Trial size 100 participants
Trial identifier NCT01066234, 2009-04-004

Summary

This study propose adjuvant concurrent chemoradiotherapy vs chemotherapy alone in completely resected microscopic N2 NSCLC

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
concurrent 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.
(Active Comparator)
chemotherapy only
four cycles of 3-weekly paclitaxel (175mg/m2) and carboplatin (AUC5.5).

Primary Outcomes

Measure
Disease-free survival
time frame: 36 months

Secondary Outcomes

Measure
Overall survival (OS)
time frame: 36 months
Pattern of relapse
time frame: 36 months
Toxicity profile
time frame: 36 months
Quality of life (QOL)
time frame: 36 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Randomized Phase II Study of Adjuvant Concurrent Chemoradiotherapy vs Chemotherapy Alone in Completely Resected Microscopic N2 Non-small Cell Lung Cancer
Principal investigator Keunchil Park, M.D., Ph.D
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Samsung Medical Center.