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Sponsored by: |
The Netherlands Cancer Institute |
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Information provided by: | The Netherlands Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00212121 |
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.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Radiation: high dose boost Procedure: boost |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | Radiation Dose Intensity Study in Breast Cancer in Young Women: a Randomized Phase III Trial of Additional Dose to the Tumor Bed |
Estimated Enrollment: | 1160 |
Study Start Date: | July 2004 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
low dose boost (16 Gy)
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Radiation: high dose boost
high dose boost
Procedure: boost
low dose versus high dose
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2: Experimental
high boost (26 Gy)
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Radiation: high dose boost
high dose boost
Procedure: boost
low dose versus high dose
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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.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion criteria
any DCIS or invasive carcinoma in 3 or fewer low-power fields (using a x 4 objective and a x 10 ocular lens, which has a diameter of 5 mm per low-power microscopic fields).
Exclusion criteria
Contact: Prof. Harry Bartelink, PhD, MD | 31 20 512 2120 | h.bartelink@nki.nl |
France | |
Institut Curie | Recruiting |
Paris, France, 75005 | |
Contact: Alain Fourquet 01 44 32 46 31 | |
Principal Investigator: Alain Fourquet | |
Centre René Huguenin | Recruiting |
Saint Cloud, France, 92210 | |
Contact: Alain Labib 01 47 11 16 32 | |
Principal Investigator: Alain Labib | |
Centre René Gauducheau | Recruiting |
Saint Herblain Cedex, France, 44805 | |
Contact: Magali Le Blanc-Onfroy | |
Hôpital J-Minjoz | Recruiting |
Besancon, France, 25030 | |
Contact: Patrick Bontemps | |
Centre Antoine Lacassagne | Recruiting |
Nice, France, 06189 | |
Contact: Adel Courdi 04 92 03 12 60 adel.courdi@nice.fnclcc.fr | |
Institut Paoli Calmettes | Recruiting |
Marseille, France, 13009 | |
Contact: Agnes Tallet | |
Centre Oscar Lambret | Recruiting |
Lille, France, 59000 | |
Contact: Yazid Belkacemi | |
Centre Henri Becquerel | Recruiting |
Rouen, France, 76000 | |
Contact: Ahmed Benyoucef 02 32 08 22 64 ahmben@rouen.fnclcc.fr | |
CHU Henri Mondor | Recruiting |
Creteil, France, 94000 | |
Contact: Jean-Leon Lagrange | |
Hôpital Saint Louis | Recruiting |
Paris, France, 75010 | |
Contact: Claude Maylin 01 42 49 90 32 claude.maylin@sls.aphp.fr | |
Institut Gustave Roussy | Recruiting |
Villejuif, France, 94800 | |
Contact: Hugo Marsiglia 01 42 11 49 88 marsiglia@igr.fr | |
Centre Paul Strauss | Recruiting |
Strasbourg, France, 67085 | |
Contact: Philippe Quetin 03 88 25 24 78 pquetin@strasbourg.fnclcc.fr | |
CHU de Tours | Recruiting |
Tours, France, 37000 | |
Contact: Isabelle Barillot 02 47 47 47 76 i.barillot@chu-tours.fr | |
Centre Hospitalier Lyon Sud | Recruiting |
Pierre Benite Cedex, France, 69495 | |
Contact: Pascale Romestaing 04 78 86 42 51 pascale.romeqtaing@chu-lyon.fr | |
Centre Val d'Aurelle | Recruiting |
Montpellier cedex 5, France, 34298 | |
Contact: Claire LEMANSKI 04 67 61 31 34 clemanski@valdorel.fnclcc;fr | |
Institut Bergonié | Recruiting |
Bordeaux, France, 33076 | |
Contact: Christel BRETON-CALLU 05 56 33 78 38 breton-callu@bergonie.org | |
Centre Eugène Marquis | Recruiting |
Rennes, France, 35000 | |
Contact: Isabelle LECOUILLARD 02 99 25 30 31 ilecouillard@rennes.fnclcc;fr | |
Netherlands | |
The Netherlands Cancer Institute | Recruiting |
Amsterdam, Netherlands, 1066 CX | |
Contact: Harry Bartelink, Professor +31 20 512 2120 h.bartelink@nki.nl | |
Principal Investigator: Harry Bartelink, Professor |
Study Chair: | Liesbeth Boersma, MD | MAASTRO Clinic, Heerlen |
Responsible Party: | The Netherlands Cancer Institute ( Prof. dr. G.M.M. Bartelink ) |
Study ID Numbers: | M03RBC-young boost, CKTO 2003-13 |
Study First Received: | September 13, 2005 |
Last Updated: | May 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00212121 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
breast cancer radiotherapy microarrays |
Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |