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NCT Number: NCT04603209

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

John Wayne Cancer Institute, Providence Saint John's Health Center

Santa Monica, California, 90404, United States

Location status: Recruiting

Location contact

Janie Grumley, MD

CONTACT

[email protected]

310-582-7100

Lisa Chaiken, MD

SUB_INVESTIGATOR

Robert Wollman, MD

SUB_INVESTIGATOR

About this study

At Providence Saint John's Health Center, there is the ongoing integration of Intra-Operative Radiation Therapy (IORT) as a standard treatment option among Breast Conserving Therapy (BCT) for individuals with in situ and early stage breast cancer. Currently, approximately 60 women per year are being treated with IORT. No repository of information of patient outcomes with this treatment has been established. This leaves a critical gap in the ability to assess the long-term outcomes of patients treated with IORT.

As the practice of using IORT to treat early stage and in situ breast cancer continues to grow at Providence Saint John's Health Center, this registry will provide the data needed to compare patient outcomes with those being treated with the traditional whole breast radiation therapy. In addition, the Providence Health & Services strives to improve patient care and outcomes with excellence whenever possible. The registry will provide the data needed to compare patient outcomes to national and community standards that can inform internal practice patterns and contribute to advancing breast cancer care nationally and internationally.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical stage Tis, T1, or T2(≤ 3cm), N0, M0 (AJCC Classification)
  • Unifocal Disease
  • Candidate for breast-conserving surgery
  • Recommended treatment by multidisciplinary team

Exclusion criteria

  • Clinical stage T3-4, N1-3, M1
  • Multifocal disease

Treatment and study plan

Intraoperative Radiation Therapy (IORT)

Radiation

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

Primary outcomes

  1. Disease Recurrence

    Time frame: 5 years

    Presence of recurrent tumor in ipsilateral breast or distant site

Secondary outcomes

  1. Disease specific survival

    Time frame: 10 years

    survival

  2. Overall Survival

    Time frame: 10 years

    survival

Study contacts

Contact information is provided by the study sponsor or research team.

Janie Grumley, MD

CONTACT

[email protected]

(310) 582-7100

Sponsors and collaborators

Lead sponsor

Saint John's Cancer Institute

Other

Registry information

Official study title

Research Registry for Intra-Operative Radiotherapy (IORT) During Breast Conserving Surgery in Patients With in Situ and Early Stage Breast Cancer

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Oct 26, 2020
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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