Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00326378 | Efficacy Study of Additional Chemotherapy After Concurrent Chemoradiation in Non-small Cell Lung Cancer | PHASE3 | COMPLETED | 434 | — | — | Oct 1, 2005 | May 1, 2015 | Jun 8, 2015 | 1 | South Korea |
| Arm | Type | Description |
|---|---|---|
| CCRT arm without consolidation chemotherapy | ACTIVE_COMPARATOR | Docetaxel 20mg/m2 \& Cisplatin 20mg/m2 (D1,8,15,22,29,36) during radiotherapy |
| CCRT arm with consolidation chemotherapy | EXPERIMENTAL | docetaxel 20mg/m2 \& cisplatin 20mg/m2 (D1,8,15,22,29,36) during radiotherapy, and followed by consolidation chemotherapy with 3-weekly docetaxel 35mg/m2 \& cisplatin 35mg/m2 (D1,8) every 3 weeks (#3). |
| Name | Type | Description |
|---|---|---|
| consolidation chemotherapy with Docetaxel plus cisplatin | DRUG | definitive CCRT, and followed by consolidation chemotherapy with three cycles of docetaxel plus cisplatin |
| CCRT arm without consolidation chemotherapy | DRUG | definitive CCRT with weekly Docetaxel/CDDP #6 without consolidation chemotherapy |
Inclusion Criteria: * Histologically proven non-small cell lung cancer * Presence of measurable disease by RECIST * Inoperable Stage IIIA or IIIB, proven by CT or MRI (except wet T4). However, N2 or N3 should be confirmed by PET or pathology. (For T4, PET is optional) * 18 years of age or older * E...