NCT00431613

Study of Docetaxel/Gemcitabine Followed by Chemo-radiotherapy (Chemo-RT), With or Without Consolidation Chemotherapy, in IIIA/IIIB Non Small Cell Lung Cancer (NSCLC)

Sequential Administration of Docetaxel/Gemcitabine Followed by Concurrent Chemo-radiotherapy, With or Without Consolidation Chemotherapy, as First Line Treatment in Patients With Unresectable Stage IIIA/IIIB NSCLC. A Randomized Phase II Study

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Hellenic Oncology Research Group · Academic / Other
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The combination of chemotherapy with radiotherapy remains the standard of therapy for patients with stage III NSCLC. A recent phase II study has presented encouraging data regarding the administration of docetaxel as consolidation treatment after definitive concurrent chemo-radiotherapy.

Detailed description

To evaluate whether the administration of consolidation therapy with docetaxel/carboplatin after induction chemotherapy followed by concurrent chemoradiotherapy, offers any advantage regarding time to tumor progression

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel	Docetaxel 75 mg/m2 IV on day 8 every 3 weeks for 2 cycles
DRUG	Gemcitabine	Gemcitabine 1100 mg/m2 on days 1 and 8 every 3 weeks for 2 cycles
DRUG	Carboplatin	Carboplatin 6AUC IV on day 1 every 3 weeks for 3 cycles
RADIATION	Chemoradiotherapy	After 21 days from the 2nd chemotherapy cycle definitive concurrent chemoradiotherapy will be started: daily fractions of 1.8 Gy for 5 days/week, for a total dose of 45 Gy. During the radiotherapy docetaxel 25 mg/m2, IV, will be administered on days 1, 8, 15, 22, 29 and carboplatin 2AUC, IV , on days 4, 11, 18, 25, 32
DRUG	Docetaxel	Docetaxel 75mg/m2 IV on day 1 for 3 cycles

Timeline

• Start date: 2006-03-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2007-02-06
• Last updated: 2015-05-29

Locations

10 sites across 1 country: Greece