Trial | NCT00198354  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    530
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.
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.
Study Started
May 31
2001
Primary Completion
Dec 31
2009
Study Completion
Dec 31
2010
Last Update
Mar 10
2016
Estimate

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)

A: pre-operative chemotherapy Experimental

pre-operative chemotherapy (gemcitabine+cisplatine, 4 cycles)

B: pre-operative chemotherapy Experimental

pre-operative chemotherapy (paclitaxel+carboplatin, 4 cycles)

C: peri-operative chemotherapy Experimental

peri-operative chemotherapy (gemcitabine+cisplatine, 4 cycles)

D: peri-operative chemotherapy Experimental

peri-operative chemotherapy (paclitaxel+carboplatin, 4 cycles)

Criteria 

Inclusion Criteria:

Histologically or cytologically NSCLC stade I or II Resectable disease WHO performance status of 2 or less

Exclusion Criteria:

NSCLC stage III or IV
No Results Posted