Adjuvant CCRT vs CT in Minimal N2 NSCLC
|Non-small Cell Lung Cancer||Radiation: concurrent chemoradiotherapy Drug: chemotherapy only||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Study of Adjuvant Concurrent Chemoradiotherapy vs Chemotherapy Alone in Completely Resected Microscopic N2 Non-small Cell Lung Cancer|
- Disease-free survival [ Time Frame: 36 months ]
- 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 ]
|Study Start Date:||April 2009|
|Estimated Study Completion Date:||March 2017|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
|Experimental: concurrent chemoradiotherapy||
Radiation: 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||
Drug: chemotherapy only
four cycles of 3-weekly paclitaxel (175mg/m2) and carboplatin (AUC5.5).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01066234
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of|
|Principal Investigator:||Keunchil Park, M.D., Ph.D||Samsung Medical Center|