Know Cancer

or
forgot password

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


Phase 3
18 Years
75 Years
Not Enrolling
Both
Non-Small Cell Lung Cancer Stage I and II, Peri-Operative Chemotherapy

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Compare 3-Years survival

Outcome Time Frame:

3 years

Principal Investigator

Alain Depierre, Pr

Investigator Role:

Principal Investigator

Investigator Affiliation:

IFCT

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

IFCT-0002

NCT ID:

NCT00198354

Start Date:

May 2001

Completion Date:

December 2008

Related Keywords:

  • Non-Small Cell Lung Cancer Stage I and II
  • Peri-Operative Chemotherapy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location