Adjuvant CCRT vs CT in Minimal N2 NSCLC
|ClinicalTrials.gov Identifier: NCT01066234|
Recruitment Status : Active, not recruiting
First Posted : February 10, 2010
Last Update Posted : April 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Radiation: concurrent chemoradiotherapy Drug: chemotherapy only||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase II Study of Adjuvant Concurrent Chemoradiotherapy vs Chemotherapy Alone in Completely Resected Microscopic N2 Non-small Cell Lung Cancer|
|Study Start Date :||April 2009|
|Primary Completion Date :||March 2014|
|Estimated Study Completion Date :||March 2017|
|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).
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01066234
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of|
|Principal Investigator:||Keunchil Park, M.D., Ph.D||Samsung Medical Center|