Preoperative Chemoradiotherapy vs. Chemotherapy Alone in Non-small Cell Lung Cancer (NSCLC) Patients With Mediastinal Lymph Node Metastases (Stage IIIA, N2): A Randomized Prospective Phase III Trial
The main objective of this trial is to compare feasibility and efficacy of sequential
neoadjuvant chemoradiotherapy with 44 Gy concomitant boost to neoadjuvant chemotherapy
alone.
Secondary objectives are to assess the value of PET in predicting pathological response and
eventfree survival in stage IIIA NSCLC, and a health economic analysis of the two regimens.
Further to compare the amount of serum DNA in patients with stage IIIA, pN2 NSCLC before
chemotherapy, before surgery and at the second follow-up visit (i.e. four months after
surgery or treatment failure for patients who can not be operated) in patients randomized
into the trial SAKK 16/00 and to correlate the DNA variation with tumor response, remission
duration and overall survival.
OUTLINE: This is a prospective randomized phase III trial. Patients are stratified according
to mediastinal bulk (5 cm or more vs less than 5 cm), weight loss in the past 6 months (5%
or more vs less than 5%), and participating center. Patients are randomized to 1 of 2
treatment arms.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Event-free survival
1 month after surgery
No
Miklos Pless, MD
Study Chair
Kantonsspital Winterthur KSW
Switzerland: Swissmedic / Swiss Federal Health Office
SAKK 16/00
NCT00030771
April 2001
September 2013
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