Single Dose Ablative Radiation Treatment for Early-Stage Breast Cancer

NCT ID: NCT02316561

Last Updated: 2018-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2018-04-30

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.

Conditions

Breast Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single dose ablative radiotherapy

Eligible patients for single dose ablative radiotherapy according to inclusion and exclusion criteria

Group Type: EXPERIMENTAL

Single dose ablative radiotherapy

Intervention Type: RADIATION

A single dose ablative radiotherapy will be delivered prior to surgery

Interventions

Single dose ablative radiotherapy

A single dose ablative radiotherapy will be delivered prior to surgery

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

UMC Utrecht

OTHER

Sponsor Role: lead

Responsible Party

K.R. Charaghvandi

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

HJGD van den Bongard, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Locations

University Medical Center Utrecht

Utrecht, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 33761491 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28274211 (View on PubMed)

Other Identifiers

NL46017.041.13

Identifier Type: -

Identifier Source: org_study_id