Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00212121
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-01-21
First Post:
2005-09-13
Brief Title:
Radiation Dose Intensity Study in Breast Cancer in Young Women
Sponsor:
The Netherlands Cancer Institute
Organization:
The Netherlands Cancer Institute
Study Overview
Official Title:
Radiation Dose Intensity Study in Breast Cancer in Young Women a Randomized Phase III Trial of Additional Dose to the Tumor Bed
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-01
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:
hypothesis 10 Gy additional boost to the tumor bed will yield an increase in local control at 10 years from 88 to 93 with still acceptable cosmesis
Detailed Description:
Title of the study
Radiation dose intensity study in breast cancer in young women a randomized phase III trial of additional dose to the tumor bed
Background and aim of the study
Several studies showed that breast conserving therapy BCT yields similar survival rates as mastectomy BCT consists of lumpectomy followed by whole breast radiotherapy WBRT Three studies showed that an additional dose to the tumor bed after 50 Gy WBRT reduces the local recurrence rate LRR The largest of these 3 studies was a recent EORTC trial which also showed that young age was an independent risk factor for LR after BCT
In patients 51 years of age the LR rate was reduced with 50 after a 66 Gy dose to the tumor bed compared to 50 Gy 5-year LRR 12 vs 59 p 002 However the LRR in young women was still quite high 1 per year Therefore the first aim of the study is to investigate whether an additional boost dose to the tumorbed 26 Gy reduces the LRR further Therefore we will compare the effect of a low boost dose 16 Gy with the effect of a high boost dose 26 Gy on the LRR but also on the cosmetic outcome
The second very important aim of this study is to investigate whether we can find genetic or protein profiles that correlate with LRR lymph node metastases distant metastases survival radiosensitivity and age For this purpose we will obtain frozen tumor material and blood samples of as many patients as possible
Population study design intervention
Patients younger than 51 years of age with stage T1-2N01-2aM0 breast cancer and where the tumor can be locally excised with acceptable cosmetic result will be randomized between a 16 Gy boost dose to the tumorbed and a 26 Gy boost dose to the tumor bed after 50 Gy WBRT Patients will be stratified based on age tumor size lymph node metastases estrogen receptor status interstitial or external boost irradiation and institution In principle frozen tumor samples and blood samples will be stored of each patient
Endpoints and statistics
The primary endpoint is LRR are 10 years The secondary endpoint is cosmetic result which will be quantified using digitized color photographs In addition patients will be asked to give their opinion about the cosmetic result using standardized questionnaires
To find an increase in the local control rate of 88 to 93 at 10 year with a power of 80 and a significance level of 5 580 patients will be included in each treatment arm
Side studies
An extremely important aspect of this trial is to obtain fresh tumor material and blood samples These will be used to determine genetic and protein profiles aimed at finding subgroups based on these profiles which may take more or less advantage of the additional radiation treatment
Radiation dose intensity study in breast cancer in young women a randomized phase III trial of additional dose to the tumor bed
Background and aim of the study
Several studies showed that breast conserving therapy BCT yields similar survival rates as mastectomy BCT consists of lumpectomy followed by whole breast radiotherapy WBRT Three studies showed that an additional dose to the tumor bed after 50 Gy WBRT reduces the local recurrence rate LRR The largest of these 3 studies was a recent EORTC trial which also showed that young age was an independent risk factor for LR after BCT
In patients 51 years of age the LR rate was reduced with 50 after a 66 Gy dose to the tumor bed compared to 50 Gy 5-year LRR 12 vs 59 p 002 However the LRR in young women was still quite high 1 per year Therefore the first aim of the study is to investigate whether an additional boost dose to the tumorbed 26 Gy reduces the LRR further Therefore we will compare the effect of a low boost dose 16 Gy with the effect of a high boost dose 26 Gy on the LRR but also on the cosmetic outcome
The second very important aim of this study is to investigate whether we can find genetic or protein profiles that correlate with LRR lymph node metastases distant metastases survival radiosensitivity and age For this purpose we will obtain frozen tumor material and blood samples of as many patients as possible
Population study design intervention
Patients younger than 51 years of age with stage T1-2N01-2aM0 breast cancer and where the tumor can be locally excised with acceptable cosmetic result will be randomized between a 16 Gy boost dose to the tumorbed and a 26 Gy boost dose to the tumor bed after 50 Gy WBRT Patients will be stratified based on age tumor size lymph node metastases estrogen receptor status interstitial or external boost irradiation and institution In principle frozen tumor samples and blood samples will be stored of each patient
Endpoints and statistics
The primary endpoint is LRR are 10 years The secondary endpoint is cosmetic result which will be quantified using digitized color photographs In addition patients will be asked to give their opinion about the cosmetic result using standardized questionnaires
To find an increase in the local control rate of 88 to 93 at 10 year with a power of 80 and a significance level of 5 580 patients will be included in each treatment arm
Side studies
An extremely important aspect of this trial is to obtain fresh tumor material and blood samples These will be used to determine genetic and protein profiles aimed at finding subgroups based on these profiles which may take more or less advantage of the additional radiation treatment
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2003-13 | OTHER_GRANT | Commissie Klinische Studies | None |