Radiation dose intensity study in breast cancer in young women: a randomised phase III trial of additional dose to the tumour bed

Commission for Clinical Applied Research (Commissie voor Klinisch Toegepast Onderzoek [CKTO]) (The Netherlands)0 sites1,160 target enrollmentDecember 20, 2005

ConditionsBreast cancer Cancer

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Breast cancer
Sponsor: Commission for Clinical Applied Research (Commissie voor Klinisch Toegepast Onderzoek [CKTO]) (The Netherlands)
Enrollment: 1160
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

2015 results presented at 3rd ESTRO Forum 2015: https://www.researchgate.net/publication/281211644_OC-0389_The_influence_of_the_boost_dose_on_cosmetic_outcome_after_breast_conserving_therapy_results_of_the_Young_Boost_Trial [added 14/02/2019] 2018 results presented at Clinical Science Symposium: https://www.ejcancer.com/article/S0959-8049(18)30267-3/pdf [added 14/02/2019]

Registry

who.int

Start Date

December 20, 2005

End Date

July 1, 2009

Last Updated

7 years ago

Study Type

Interventional

Investigators

Sponsor

Commission for Clinical Applied Research (Commissie voor Klinisch Toegepast Onderzoek [CKTO]) (The Netherlands)

Eligibility Criteria

Inclusion Criteria

•1\. Age 50 years or younger
•2\. Histological diagnosis of invasive mammary cancer including all subtypes of invasive adenocarcinoma
•3\. Tumour location and extension imaged prior to surgery using at least mammography and ultrasound
•4\. Unicentric tumours and multifocal tumours removed using a wide local excision; microscopic radical resection (focally involved margins allowed, defined as: any Ductal Carcinoma In Situ \[DCIS] or invasive carcinoma in three 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)
•5\. Sentinel lymph node biopsy and/or axillary lymph node dissection has been performed
•6\. Breast cancer stage: pT1\-2pN0\-2a M0
•7\. No treatment is allowed prior to surgery (no neoadjuvant chemotherapy, no neoadjuvant hormonal therapy, no pre\-operative radiotherapy)
•8\. In cases where no adjuvant chemotherapy is given, wide local excision has been performed less than 10 weeks before the start of radiotherapy
•9\. In cases where adjuvant chemotherapy is given immediately after surgery, wide local excision has been performed less than 6 months before the start of radiotherapy, and chemotherapy should be completed less than 6 weeks before the start of radiotherapy
•10\. In cases where hormonal treatment is planned, this is given after completion of the radiotherapy

Exclusion Criteria

•1\. Residual microcalcifications on mammogram
•2\. All histological types of malignancies other than invasive adenocarcinoma
•3\. In situ carcinoma of the breast, without invasive tumour
•4\. Concurrent pregnancy
•5\. Multicentric tumours, and multifocal tumours excised using multiple excisions
•6\. Invasive breast cancer in both breasts