NCT01066234

Adjuvant CCRT vs CT in Minimal N2 NSCLC

A Randomized Phase II Study of Adjuvant Concurrent Chemoradiotherapy vs Chemotherapy Alone in Completely Resected Microscopic N2 Non-small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
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.
DRUG	chemotherapy only	four cycles of 3-weekly paclitaxel (175mg/m2) and carboplatin (AUC5.5).

Timeline

• Start date: 2017-10-23
• Primary completion: 2021-01-18
• Completion: 2021-01-18
• First posted: 2010-02-10
• Last updated: 2021-03-22

Locations

1 site across 1 country: South Korea