Skip to content

Partial Breast Radiotherapy in Low-risk Breast cancer group using a MR-guided adaptive approach; a phase II study

Partial Breast Radiotherapy in Low-risk Breast cancer group using a MR-guided adaptive approach; a phase II study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON26191
Enrollment
50
Registered
2020-02-04
Start date
2017-10-10
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

Patients will be treated using MRgRT in a course of 5 fractions of 6 Gy or 6.5 Gy, depending on tumor characteristics, per fraction in two weeks overall treatment time. The MRIdian treatment delivery

Sponsors

Amsterdam UMC, location VUmc
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Good candidates for partial breast irradiation according to the GEC-ESTRO recommendations are patients selected in the low-risk group. In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Age > 50 years - WHO performance score 0-2 - Pathology proven breast cancer with following histology: invasive ductal carcinoma, mucinous, tubular, medullary, colloid cc, and associated LCIS - Any histologic grade - Any hormonal receptor status - T-stage: Tumor size = 3cm (pT1-2) - N-stage: No positive lymph nodes examined by sentinel lymph node biopsy or axillary lymph node dissection (at least 6 nodes pathologically examined) - Radical resection of tumor with = 2mm surgical margin free of tumour - All patients should be able to undergo MRI scans - Ability to provide written informed consent. - Ability to perform breath-hold for at least 17 seconds

Exclusion criteria

Exclusion criteria: According to the GEC-ESTRO recommendations, subject who meets any of the following criteria will be excluded from participation in this study: - Breast cancer histology of invasive lobular carcinoma, ductal carcinoma in situ sec - Breast cancer with a multicentric or multifocality character - An extensive intraductal component in pathology examination - Lympho-vascular invasion in the pathology examination - Treatment with neoadjuvant chemotherapy before lumpectomy - Breast conserving surgery with an oncoplastic breast surgery technique - Re-excision of tumour in ipsilateral breast - Open surgical wound or wound infection - Previous irradiation in the ipsilateral breast - Contra-indications for MRI

Design outcomes

Primary

MeasureTime frame
Early and early-delayed toxicity (CTCAE v. 4.0)

Secondary

MeasureTime frame
Cosmetic outcome (panel scoring, BCCT.core software and patient self-evaluation) and quality of life (EORTC-QoL C30 & Breast Cancer module QLQ BR23)

Contacts

Public ContactShyama Tetar

Amsterdam UMC, location VUmc

su.tetar@amsterdamumc.nl+31 (0)20 4440413

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)