Radiation Dose Intensity Study in Breast Cancer in Young Women

• Register: ClinicalTrials.gov
• Last refreshed on: 31 January 2022
• Main ID: NCT00212121
• Date of registration: 13/09/2005
• Prospective Registration: No
• Primary sponsor: The Netherlands Cancer Institute
• Public title: Radiation Dose Intensity Study in Breast Cancer in Young Women
• Scientific title: Radiation Dose Intensity Study in Breast Cancer in Young Women: a Randomized Phase III Trial of Additional Dose to the Tumor Bed
• Date of first enrolment: July 2004
• Target sample size: 2400
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT00212121
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

France, Netherlands

Contacts

• Name: Liesbeth Boersma, MD
• Affiliation: MAASTRO Clinic, Heerlen

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Radiation: high dose boost

Procedure: boost

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

M03RBC-young boost

2003-13

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

UNICANCER