NCT00913705

Neoadjuvant or Adjuvant Chemotherapy in Patients With Operable Non-small-cell Lung Cancer

Randomized Trial of Surgery With or Without Paclitaxel Plus Carboplatin as Neoadjuvant or Adjuvant Chemotherapy in Patients With Operable, Non-small-cell Lung Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 624 (estimated)
• Sponsor: Spanish Lung Cancer Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Open-label multicenter randomized Phase III trial.

Detailed description

Randomized trial of surgery with or without Paclitaxel (taxol) plus Carboplatin as neoadjuvant or adjuvant chemotherapy in patients with operable, non-small-cell lung cancer.

Conditions

• Non-Small-Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Neoadjuvant chemotherapy (taxol and carboplatin)	Taxol: 200mg/m2 infusion over 3 hours; Carboplatin: AUC= 6 at the end of the Taxol infusion. Administration of 3 cycles at 21-day intervals. Prior to surgery.
DRUG	Adjuvant chemotherapy (taxol and carboplatin)	Taxol: 200mg/m2 infusion over 3 hours; Carboplatin: AUC= 6 at the end of the Taxol infusion. Administration of 3 cycles at 21 days interval. Post-surgery
PROCEDURE	Surgery	Surgery

Timeline

• Start date: 1999-09-01
• Primary completion: 2007-12-01
• Completion: 2009-06-01
• First posted: 2009-06-04
• Last updated: 2022-06-13