Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00208273
Status:
COMPLETED
Last Update Posted:
2021-06-02
First Post:
2005-09-13
Brief Title:
Concomitant and Sequential Radiohormonotherapy in Adjuvant Breast Cancer
Sponsor:
Institut du Cancer de Montpellier - Val dAurelle
Organization:
Institut du Cancer de Montpellier - Val dAurelle
Study Overview
Official Title:
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 andor PgR Positive Tumors
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial will compare grade 2 or greater late skin toxicities of concomitant letrozole-radiotherapy and radiotherapy followed by letrozole as adjuvant therapy for postmenopausal women with receptor estrogen receptor ER andor progesterone receptor PgR positive tumors Each drug will be prescribed for 5 years
Detailed Description:
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 25 mg daily for 5 years started three weeks before the first day of adjuvant radiotherapy
Arm B Letrozole 25 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
A ratio of 1 to 1 will be used for the randomization process between the two arms
Arm A Letrozole 25 mg daily for 5 years started three weeks before the first day of adjuvant radiotherapy
Arm B Letrozole 25 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None