We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Radiation Dose Intensity Study in Breast Cancer in Young Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00212121
Recruitment Status : Active, not recruiting
First Posted : September 21, 2005
Last Update Posted : October 26, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: high dose boost Procedure: boost Phase 3

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiation Dose Intensity Study in Breast Cancer in Young Women: a Randomized Phase III Trial of Additional Dose to the Tumor Bed
Study Start Date : July 2004
Primary Completion Date : December 2015
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
low dose boost (16 Gy)
Radiation: high dose boost
high dose boost
Procedure: boost
low dose versus high dose
Experimental: 2
high boost (26 Gy)
Radiation: high dose boost
high dose boost
Procedure: boost
low dose versus high dose


Outcome Measures

Primary Outcome Measures :
  1. Local control at 10 yr [ Time Frame: at every follow up visit (< 2 months after last radiation treatment and thereafter yearly ]

Secondary Outcome Measures :
  1. Cosmetic outcome [ Time Frame: prior to radiotherapy, 1 year after radiotherapy and thereafter every 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Age 50 years or younger.
  • Histological diagnosis of invasive mammary cancer including all subtypes of invasive adenocarcinoma.
  • Tumor location and extension imaged prior to surgery using at least mammography and ultrasound.
  • Unicentric tumors and multifocal tumors removed using a wide local excision; microscopic radical resection (focally involved margins allowed, defined as:

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).

  • Sentinel lymph node biopsy and/or axillary lymph node dissection has been performed.
  • Breast cancer stage: pT1-2pN0-2a M0.
  • No treatment is allowed prior to surgery (no neoadjuvant chemotherapy, no neoadjuvant hormonal therapy, no pre-operative radiotherapy).
  • In cases where no adjuvant chemotherapy is given, wide local excision has been performed < 10 weeks before the start of radiotherapy.
  • In cases where adjuvant chemotherapy is given immediately after surgery, wide local excision has been performed < 6 months before the start of radiotherapy, and chemotherapy should be completed < 6 weeks before the start of radiotherapy.
  • In cases where hormonal treatment is planned, this is given after completion of the radiotherapy.
  • No previous history or synchronous malignant tumor in the other breast, previous history of malignant disease, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin.
  • ECOG performance scale 2 or less.

Exclusion criteria:

  • Residual microcalcifications on mammogram.
  • All histological types of malignancies other than invasive adenocarcinoma.
  • In situ carcinoma of the breast, without invasive tumor.
  • Concurrent pregnancy.
  • Multicentric tumors, and multifocal. tumors excised using multiple excisions * Invasive breast cancer in both breasts.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00212121


Locations
France
Hôpital J-Minjoz
Besancon, France, 25030
Institut Bergonié
Bordeaux, France, 33076
CHU Henri Mondor
Creteil, France, 94000
Centre Oscar Lambret
Lille, France, 59000
Institut Paoli Calmettes
Marseille, France, 13009
Centre Val d'Aurelle
Montpellier cedex 5, France, 34298
Centre Antoine Lacassagne
Nice, France, 06189
Institut Curie
Paris, France, 75005
Hôpital Saint Louis
Paris, France, 75010
Centre Hospitalier Lyon Sud
Pierre Benite Cedex, France, 69495
Centre Eugène Marquis
Rennes, France, 35000
Centre Henri Becquerel
Rouen, France, 76000
Centre René Huguenin
Saint Cloud, France, 92210
Centre René Gauducheau
Saint Herblain Cedex, France, 44805
Centre Paul Strauss
Strasbourg, France, 67085
CHU de Tours
Tours, France, 37000
Institut Gustave Roussy
Villejuif, France, 94800
Netherlands
The Netherlands Cancer Institute
Amsterdam, Netherlands, 1066 CX
Sponsors and Collaborators
The Netherlands Cancer Institute
UNICANCER
Investigators
Study Chair: Liesbeth Boersma, MD MAASTRO Clinic, Heerlen
More Information

Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT00212121     History of Changes
Other Study ID Numbers: M03RBC-young boost
2003-13 ( Other Grant/Funding Number: Commissie Klinische Studies )
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: June 2016

Keywords provided by The Netherlands Cancer Institute:
breast cancer
radiotherapy
microarrays

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases