A Phase II Randomized Study to Compare Skin Late Toxicities of Concomitant Letrozole-Radiotherapy and Radiotherapy Followed by Letrozole as Adjuvant Therapy for Postmenopausal Women With Receptor (ER and/or PgR) Positive Tumors
This trial is an open-label randomized multicenter phase II study.
A ratio of 1 to 1 will be used for the randomization process between the two arms:
- Arm A : Letrozole 2.5 mg daily for 5 years started three weeks before the first day of
adjuvant radiotherapy.
- Arm B : Letrozole 2.5 mg daily for 5 years started three weeks after the last day of
adjuvant radiotherapy.
All patients will be followed every 3 months for toxicities, disease status and for survival
until death.
Interventional
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Sub-cutaneous late toxicity
2 years
Yes
David AZRIA, MD,PhD
Principal Investigator
CRLC Val d'Aurelle
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
CO-HO-RT/2004/31
NCT00208273
January 2005
February 2007
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