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NCT Number: NCT03536897

IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry

This is a prospective, registry trial which will enroll women aged 65 and above with early stage, low risk breast cancer who will be treated with partial mastectomy and intraoperative radiation therapy (IORT). The primary aim is to determine the 5-year risk of in-breast tumor recurrence. Secondary aims include identification of acute- and late-toxicity, cosmetic result, disease-free survival and overall survival.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

65 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Mount Carmel West Hospital

Columbus, Ohio, 43222, United States

Location status: Recruiting

Location contact

Malolan S Rajagopalan, MD

CONTACT

[email protected]

614-234-5402

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female
  • ECOG performance status 0-1
  • Age 65 years or older
  • cT1 or cT2 (≤3.0 cm)
  • Invasive ductal carcinoma histology
  • Estrogen receptor positive (ER+)
  • Grade 1 or Grade 2
  • Clinically negative lymph nodes (cN0) by examination, imaging and/or nodal sampling
  • Suitable for breast conserving surgery and radiation therapy
  • Patient must be able to provide study-specific informed consent

Exclusion criteria

  • Multi-centric cancer not amenable to single lumpectomy
  • Prior ipsilateral whole breast radiation
  • Known BRCA 1 or BRCA 2 mutation
  • Status post neoadjuvant hormonal or chemotherapy
  • Invasive lobular histology
  • Pure ductal carcinoma in situ (DCIS)
  • Grade 3
  • Diffuse suspicious microcalcifications

Treatment and study plan

IORT

Radiation

Intraoperative radiation therapy with INTRABEAM system to a dose of 20 Gy

Primary outcomes

  1. In-Breast Tumor Recurrence (IBTR)

    Time frame: 5 years

    Ipsilateral In-Breast Tumor Recurrence (IBTR): defined as biopsy-proved invasive or in situ breast cancer (except LCIS) in the ipsilateral breast.

Secondary outcomes

  1. Late Toxicity

    Time frame: 5 years

    Degree of late radiation toxicity will be scored based upon RTOG/EORTC (Radiation Therapy Oncology Group/Eastern Oncology Radiation Therapy Consortium) late radiation morbidity scoring schema for subcutaneous tissue as well as cosmetic result.

    The RTOG/EORTC late radiation morbidity scoring schema on subcutaneous tissue is as follows:

    • GRADE 1: Slight induration (fibrosis) and loss of subcutaneous fat
    • GRADE 2: Moderate fibrosis but asymptomatic; slight field contracture; <10% linear reduction
    • GRADE 3: Severe induration and loss of subcutaneous tissue; field contracture > 10% linear measurement
    • GRADE 4: Necrosis

  2. Acute Toxicity

    Time frame: 3 months

    Acute radiation toxicity will be scored at the first follow-up visit after IORT (4-6 weeks after treatment).

    Radiation dermatitis will be scored based upon CTCAE (Common Terminology Criteria for Adverse Events) v4.03 scale as follows:

    • GRADE 1: Faint erythema or dry desquamation
    • GRADE 2: Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema
    • GRADE 3: Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion
    • GRADE 4: Life threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated

    Other acute toxicity will also be scored per the CTCAE v4.03 scale and will be rated on the relation to radiation therapy (definitely related, probably related, possibly related, unlikely related, unrelated)

  3. Disease Free Survival

    Time frame: 5 yeras

    Disease Free Survival

  4. Overall Survival

    Time frame: 5 years

    Overall Survival

Study contacts

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

Lynn Shaffer, PhD

CONTACT

[email protected]

614-234-3625

Sponsors and collaborators

Lead sponsor

Mount Carmel Health System

Other

Registry information

Official study title

Intraoperative Radiation Therapy (IORT) Following Breast Conserving Surgery for Early Stage Breast Cancer Registry

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
May 25, 2018
Registry last updated
Nov 27, 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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