Radiation Dose Intensity Study in Breast Cancer in Young Women
- Conditions
- Breast Cancer
- Interventions
- Radiation: high dose boostProcedure: boost
- Registration Number
- NCT00212121
- Lead Sponsor
- The Netherlands Cancer Institute
- 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 5.9%, p \< 0.02). 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 2400
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 boost low dose boost (16 Gy) 2 high dose boost high boost (26 Gy) 2 boost high boost (26 Gy) 1 high dose boost low dose boost (16 Gy)
- Primary Outcome Measures
Name Time Method Local control at 10 yr at every follow up visit (< 2 months after last radiation treatment and thereafter yearly
- Secondary Outcome Measures
Name Time Method Cosmetic outcome prior to radiotherapy, 1 year after radiotherapy and thereafter every 3 years
Trial Locations
- Locations (18)
Hôpital J-Minjoz
🇫🇷Besancon, France
Centre Oscar Lambret
🇫🇷Lille, France
Institut Bergonié
🇫🇷Bordeaux, France
CHU Henri Mondor
🇫🇷Creteil, France
Institut Paoli Calmettes
🇫🇷Marseille, France
Centre Val d'Aurelle
🇫🇷Montpellier cedex 5, France
Institut Curie
🇫🇷Paris, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Hôpital Saint Louis
🇫🇷Paris, France
Centre Eugène Marquis
🇫🇷Rennes, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite Cedex, France
Centre Henri Becquerel
🇫🇷Rouen, France
Centre René Huguenin
🇫🇷Saint Cloud, France
Centre René Gauducheau
🇫🇷Saint Herblain Cedex, France
Centre Paul Strauss
🇫🇷Strasbourg, France
CHU de Tours
🇫🇷Tours, France
Institut Gustave Roussy
🇫🇷Villejuif, France
The Netherlands Cancer Institute
🇳🇱Amsterdam, Netherlands