NCT00198354

Stage I/II NSCLC Perioperative Chemotherapy

Phase III Trial Comparing 2 Chemotherapy Schedules (Preoperative vs Pre and Postoperative) in Stage I and II NSCLC

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 530 (actual)
• Sponsor: Intergroupe Francophone de Cancerologie Thoracique · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The addition of chemotherapy to lung cancer surgery is now considered as the standard of care. Solid data support postoperative chemotherapy but only few results are available in the preoperative setting. To define which timing of perioperative chemotherapy offers the best survival improvement, the IFCT 0002 study is conducted in France.

Detailed description

In this multicenter study, patients are randomized to receive either two preoperative chemotherapy cycles plus two additional preoperative cycles if they respond to chemotherapy, or two preoperative plus two postoperative cycles in case of response.

Conditions

• Non-small Cell Lung Cancer Stage I and II
• Peri-operative Chemotherapy

Interventions

Type	Name	Description
DRUG	gemcitabine + cisplatine	gemcitabine 1250 mg/m², D1+D8 cisplatine 80 mg/m², D1 (D1=D22)
DRUG	Paclitaxel + Carboplatine	paclitaxel 200 mg/m², D1 carboplatin AUC 6, D1 (D1=D22)

Timeline

• Start date: 2001-05-01
• Primary completion: 2009-12-01
• Completion: 2010-12-01
• First posted: 2005-09-20
• Last updated: 2016-03-10

Locations

1 site across 1 country: France