NCT01295723

Brief Summary

Hypofractionated intraoperative boost (HIOB) is defined as hypofractionated WBRT (40.5 Gy in 2.7 Gy per fraction) preceded by an intraoperative boost to the tumor bed (10 Gy IOERT). The HIOB study concept will test whether such a combined schedule is superior or iso-effective standard RT in terms of local control and cosmetic outcome.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 11, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 14, 2011

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

May 11, 2022

Status Verified

May 1, 2022

Enrollment Period

10.9 years

First QC Date

February 11, 2011

Last Update Submit

May 9, 2022

Conditions

Invasive Lobular and Ductal Carcinoma

Keywords

Breast cancerRadiation therapyMobetronIOERTIORTHypofractionated radiation therapyPartial breast radiation

Outcome Measures

Primary Outcomes (1)

  • Assessment of acute and late toxicity

    Assessment of acute toxicity of breast irradiation according to CTC-toxicity Scoring - systems: * At the end of Radiation Therapy * At time of first follow-up investigation (week 8 - 10) Assessment of late toxicity according to NSABP scoring - systems at 6, 12, 24, 36, 48, and 60 months

    5 years

Secondary Outcomes (3)

  • Cosmetic Evaluation

    5 years

  • Disease Free Survival

    5 years

  • Overall Survival

    5 Years

Study Arms (1)

Intraoperative Electron Radiation Therapy

EXPERIMENTAL

A single dose of electron irradiation given at the surgical site during the operation to remove the cancerous tumor will replace the usual 5-8 days of localized radiation. Hypofractionated Whole Breast Radiation Therapy must start within 14-56 days post operatively.

Radiation: Hypofractionated Whole Breast Radiation TherapyRadiation: Intraoperative Electron Radiation Therapy

Interventions

Hypofractionated Whole Breast Radiation TherapyRADIATION

Hypofractionated Whole Breast Radiation Therapy must start within 14-56 days postoperatively (week 2-8 post-op) * Single reference dose per fraction: 2.7 Gy (ICRU) * Number of fractions: 15 * Number of fractions per week: 5 * Regular Radiation Therapy breaks: Weekend/ Holidays (not exceeding 7 days break) * Total dose: 50.5 Gy (40.5 WBRT + 10 Gy boost) Radiation: Intraoperative Electron Radiation Therapy

Intraoperative Electron Radiation Therapy
Intraoperative Electron Radiation TherapyRADIATION

Intraoperative Electron Radiation Therapy (IOERT) is delivered after completion of the lumpectomy and sentinel node procedure. IOERT is performed on mobile or fixed linac with variable electron energies in the range of 4-12 MeV

Also known as: Mobetron
Intraoperative Electron Radiation Therapy

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histological proven invasive breast carcinoma (ductal and lobular)
  • Age \> 40 years
  • Karnofsky performance status \>70%
  • Single discrete tumor or focal microcalcifications that can be imaged on a specimen radiograph or multifocal disease within the same quadrant with a maximum dimension of 4 cm (invasive foci)
  • Nodal Status: NO-1
  • Clear surgical margins: R0; min 2mm. Re-excision after IOERT is permitted but not required to achieve (-) margin.
  • All grades G1 - G3
  • Any hormonal receptor and Her-2 status
  • Informed consent

You may not qualify if:

  • In-situ Carcinoma without invasive component or multifocal disease \> 4 cm
  • Tumor stage: T3 or 4
  • Nodal Status \> N1 pathologically
  • Surgical margins \< 2mm
  • Multicentricity
  • Previous radiotherapy to the involved breast
  • Karnofsky Index \< 70%
  • Mixed connective tissue diseases e.g. rheumatoid polyarthritis, thromboangitis obliterans, systemic lupus.
  • Distant metastases
  • Unable to provide written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph Hospital of Orange

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Carcinoma, DuctalBreast Neoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Ductal, Lobular, and MedullaryNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Afshin Forouzannia, M.D.

    The Center for Cancer Prevention & Treatment at St. Joseph Hospital of Orange

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2011

First Posted

February 14, 2011

Study Start

January 1, 2011

Primary Completion

December 1, 2021

Study Completion

December 1, 2022

Last Updated

May 11, 2022

Record last verified: 2022-05

Locations

US(1)