Registry for Intra-Operative Radiotherapy During Breast Conserving Surgery in Patients With Early Stage Breast Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSaint John's Cancer Institute

About this trial

This is a prospective, registry study that will enroll all women with early stage breast cancer who will be treated with intraoperative radiotherapy (IORT) during breast-conserving surgery. The purpose of this study is to further validate the long-term effectiveness and safety of this treatment method. We aim to assess short and long-term patient outcomes associated with IORT, including perioperative complications, local and distance disease recurrences, as well as disease-free survival and overall survival.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical stage Tis, T1, or T2(≤ 3cm), N0, M0 (AJCC Classification)

Unifocal Disease

Candidate for breast-conserving surgery

Recommended treatment by multidisciplinary team

Disqualifiers

Clinical stage T3-4, N1-3, M1

Multifocal disease

Trial population

Any individual aged ≥ 18 years with early stage breast cancer who is determined to be suitable candidates for breast-conserving surgery and IORT by a multidisciplinary team.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Intraoperative Radiation Therapy (IORT)

    Radiation

    IORT involving 50kV Xrays to a dose of 20 Gy during breast-conserving surgery

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: IORT1 intervention

Trial outcomes

Primary outcomes

1

Disease Recurrence

Presence of recurrent tumor in ipsilateral breast or distant site

Time frame
5 years

Secondary outcomes

1

Disease specific survival

survival

Time frame
10 years
2

Overall Survival

survival

Time frame
10 years

Other outcomes

Sponsors and contacts

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