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

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

Status

Recruiting

Phases

Phase 2

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45437

Enrollment

Registered

2017-09-15

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 carcinoma of the breast

Interventions

MR-guided

partial breast

radiotherapy

stereotactic

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion 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: - 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

Measure	Time frame
To evaluate early and early-delayed toxicity (defined as the first year following treatment). Toxicity will be monitored at fixed time points using CTCAE, before and during treatment and 3, 9 and 18 months after breast conserving surgery	—

Secondary

Measure	Time frame
Cosmetic outcome and Quality of Life are important secondary outcome measures. Quality of Life will be evaluated using EORTC-QOL questionnaires (EORTC-QoL C30 & Breast Cancer module QLQ BR23). Cosmetic outcome will be evaluated using three previously used methods in VUmc consisting of a panel, BCCT.core-software and patient self-evaluation. Offline dosimetric comparison between this new MR-guided adaptive approach in breath-hold and current techniques described in recent literature	—

Measure

Time frame

Cosmetic outcome and Quality of Life are important secondary outcome measures. Quality of Life will be evaluated using EORTC-QOL questionnaires (EORTC-QoL C30 & Breast Cancer module QLQ BR23). Cosmetic outcome will be evaluated using three previously used methods in VUmc consisting of a panel, BCCT.core-software and patient self-evaluation. Offline dosimetric comparison between this new MR-guided adaptive approach in breath-hold and current techniques described in recent literature

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Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)