Clinical trial NCT02316561: Single Dose Ablative Radiation Treatment for Early-Stage Breast Cancer
Official title: Single Dose Ablative Preoperative Radiation Treatment for Early-Stage Breast Cancer in Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasm
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2014-12-15
Enrollment: 25
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the feasibility of a preoperative, single dose, ablative partial breast radiation treatment in patients with early-stage breast cancer.

Detailed description: A total of twenty-five patients will be treated with a single dose preoperative ablative radiation treatment. After a vigilant follow-up with MRI, breast conserving surgery will be performed 6 months after the ablative radiation treatment. The total follow-up time is 10 years.

This study aims to present an ablative radiotherapy treatment approach that could resolve to some extent the disadvantages of current breast conserving treatment in elderly low-risk breast cancer patients who are currently not treated according to guidelines due to co-morbidity.

Eligibility criteria: Inclusion Criteria:

* WHO performance scale ≤2.
* Females at least 50 years of age with unifocal cT1N0 breast cancer or females at least 70 years of age with an unifocal cT1-2(maximum 3 cm)N0 breast cancer:

  - Tumor size as assessed on MRI
* On tumor biopsy:

  * Non-lobular invasive histological type carcinoma.
  * LCIS is accepted.
  * ER positive tumor receptor.
* Tumor negative sentinel node.
* Adequate communication and understanding skills of the Dutch language.

Exclusion Criteria:

* Legal incapacity
* Indication for chemotherapy or immunotherapy (i.e. patients with an indication for endocrine therapy are eligible)
* BRCA gene mutation.
* Previous history of breast cancer
* Other type of malignancy within 5 years before breast cancer diagnosis. For adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin no specific time span from breast cancer diagnosis is required for inclusion
* Her2neu positive tumor.
* Previous history of ipsilateral breast surgery and impaired cosmetic outcome, as assessed by the treating surgeon or radiation-oncologist.
* Collagen synthesis disease.
* Signs of extensive DCIS component on histological biopsy or mammogram.
* Invasive lobular carcinoma.
* MRI absolute contraindications as defined by the Radiology Department.
* Nodal involvement with cytological or histological confirmation.
* Treatment with neo-adjuvant systemic therapy.

Primary outcomes:
measure: Pathological complete response
timeFrame: 6 months after radiotherapy
Secondary outcomes:
measure: Radiological tumor response on MRI according to the RECIST criteria
timeFrame: Within 1 week and 2, 4 and 6 months after radiotherapy
measure: Radiological tumor response on FDG-PET-CT according to the PERCIST criteria
timeFrame: At 6 months after radiotherapy
measure: Quality of life according to EORTC QLQ-BR23 and EORTC QLQ-C30 questionnaires
timeFrame: Until 10 years after radiotherapy
measure: Cosmetic results as assessed by patient questionnaire, radiation oncologist evaluation and BCCT.core software
timeFrame: Until 10 years after radiotherapy
measure: Frailty assessment according to the Groningen Frailty Indicator
timeFrame: Until 10 years after radiotherapy
measure: Functionality assessment using patient questionnaires on physical activity and the Hospital Anxiety and Depression Scale questionnaire.
timeFrame: Until 10 years after radiotherapy
measure: Local relapse rates
timeFrame: Until 10 years after radiotherapy
measure: Regional relapse rates
timeFrame: Until 10 years after radiotherapy
measure: Distant relapse rates
timeFrame: Until 10 years after radiotherapy
measure: Disease free survival
timeFrame: Until 10 years after radiotherapy
measure: Overall survival
timeFrame: Until 10 years after radiotherapy
Other outcomes:
measure: Tumor related genetic characteristics associated with radiotherapy responsiveness
timeFrame: Until 10 years after radiotherapy
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: UMC Utrecht
name: HJGD van den Bongard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Groot Koerkamp ML, de Hond YJM, Maspero M, Kontaxis C, Mandija S, Vasmel JE, Charaghvandi RK, Philippens MEP, van Asselen B, van den Bongard HJGD, Hackett SS, Houweling AC. Synthetic CT for single-fraction neoadjuvant partial breast irradiation on an MRI-linac. Phys Med Biol. 2021 Apr 16;66(8). doi: 10.1088/1361-6560/abf1ba.
citation: Charaghvandi RK, van Asselen B, Philippens ME, Verkooijen HM, van Gils CH, van Diest PJ, Pijnappel RM, Hobbelink MG, Witkamp AJ, van Dalen T, van der Wall E, van Heijst TC, Koelemij R, van Vulpen M, van den Bongard HJ. Redefining radiotherapy for early-stage breast cancer with single dose ablative treatment: a study protocol. BMC Cancer. 2017 Mar 9;17(1):181. doi: 10.1186/s12885-017-3144-5.