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Intraoperative Radiotherapy After Local Recurrence in Breast Cancer (RE-IORT01)

Primary Purpose

Breast Carcinoma

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
tumorectomy
Intra Operative Radiotherapy
Sponsored by
Institut du Cancer de Montpellier - Val d'Aurelle
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Carcinoma

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically proven non-lobular invasive breast recurrence
  • Time from whole breast radiation following the initial lumpectomy >5 years
  • Unifocal tumor
  • Recurrent tumor size ≤ 2 cm
  • Adequate breast size for a second breast-conserving surgery with acceptable cosmetic result
  • Bilateral breast mammogram within 90 days prior to study entry
  • Breast MRI within 90 days prior to study entry
  • Histological grade I-II
  • Estrogen-receptor-positive tumor (ER+)
  • Cerb2-negative tumor
  • N0
  • M0
  • Prior radiotherapy delivered within a standard fractionation schedule
  • Performance status (ECOG) 0-1
  • Women ≥ 50 years -Absence of any psychological, familial, sociological, or geographical conditions with a potential to hamper compliance with the study and follow- up schedule
  • Affiliated to the French Health Insurance regimen
  • Written and signed informed consent form.

Exclusion Criteria:

  • Multifocal and/or multicenter recurrence
  • Lobular carcinoma
  • Estrogen-receptor-negative tumor (ER-)
  • Cerb2 (her2) overexpressed - breast cancer
  • Extensive intraductal component (EIC) on biopsy
  • Lymph vessel invasion on biopsy
  • N1-3 status: Regional cytological or histologically proven node recurrence
  • M1 status: Metastatic disease
  • cT4 (Skin or muscle involvement) or Paget's disease of the nipple
  • Prior radiotherapy delivered within an accelerated or hypo-fraction schedule
  • Prior malignancy other than non-melanoma skin cancer unless the patient has been disease free for at least 5 years
  • Patients with a small breast volume, technically unsatisfactory for a second conservative surgery or intraoperative breast irradiation.
  • Preoperative chemotherapy or hormone therapy for local relapse
  • Connective tissue disease or scleroderma, contraindicating radiotherapy
  • Known BRCA1/2 gene mutation (genetic testing is not required)

Sites / Locations

  • Institut Bergonié
  • Chu Brest
  • Centre George Francois Leclerc
  • Centre Léon Bérard
  • CHU La TIMONE
  • Institut Paoli Calmette
  • ICM
  • Institut de Cancérologie de l'Ouest

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

surgery and Intra Operative Radiotherapy

Arm Description

Surgery : Tumorectomy will be performed according to the current standards, obtaining "clear" margins. The axillary lymph node control will depend on the initial management (clinical and ultrasound) of these N0 patients, chosen by the teams. Intra Operative Radiotherapy (IORT): After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeam™) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure.

Outcomes

Primary Outcome Measures

The tolerance of RIOP (Intra Operative Radiotherapy) in patients with delayed local recurrences, after a second conservative treatment of breast cancer
Fibrosis rate of RIOP grade 2 at 12 months of IORT (Intra Operative Radiotherapy) according to NCI CTCAE v4.0 classification

Secondary Outcome Measures

Cosmetic outcome evaluated by photography
A esthetic evaluation (photographs)
Rate of early and late toxicities
Rate of Early toxicities (Hematoma, Lymphorrhea, Breast infection) Late toxicities (telangiectasia, breast pain, skin hyperpigmentation, skin ulceration, skin atrophy)
Local relapse-free survival
Time from baseline to the apparition of local relapse
Metastasis relapse-free survival
Time from baseline to the apparition of metastatic relapse
Disease-free survival.
Time without relapse
Overall survival
Time from baseline to the apparition of relapse
Free interval without mastectomy.
Time from baseline to the mastectomy

Full Information

First Posted
March 2, 2015
Last Updated
June 13, 2023
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
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1. Study Identification

Unique Protocol Identification Number
NCT02386371
Brief Title
Intraoperative Radiotherapy After Local Recurrence in Breast Cancer
Acronym
RE-IORT01
Official Title
Feasibility Clinical Trial of Intraoperative Radiotherapy (IORT) and Second Breast-conserving-surgery After Local Recurrence of Breast Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2014 (Actual)
Primary Completion Date
June 12, 2020 (Actual)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators propose a prospective, multicenter, single arm Phase II design to evaluate the feasibility of repeated breast-conserving surgery combined with re- irradiation using IORT after local recurrence of breast carcinoma.
Detailed Description
Currently, the rate of ipsilateral breast tumor recurrence (IBTR) after breast- conserving surgery and radiotherapy remains at 10% at 10 years to 15% at 20 years, respectively. IBTR is an independent predictor of poor survival with a 3 to 4.6 increased risk of cancer-related death. In a heterogeneous population, local control remains a major therapeutic challenge for these relapses, especially those considered of better prognosis, namely occurring late and of low histological grade. Therapeutic de-escalation is possible for these relapses to avoid a mutilating and often traumatic mastectomy. However, this second conservative surgery has a high rate of second local relapse (19 to 50% at 5 years) due to the absence of a re-irradiation, rendered impossible by the problem of tolerance of previously irradiated tissues. Retrospective or prospective studies on partial breast irradiation (PBI) in adjuvant setting report promising results, both in terms of tolerance (saving healthy tissue) and local control (74% to 100% at 5 years). Used techniques include brachytherapy, external beam radiotherapy and intraoperative radiotherapy (IORT). IORT is now the subject of renewed interest in breast cancer. It has the advantages of high-precision ballistics on the operated area and of preservation of healthy tissue. To date, no prospective data, however, have been published in the indication of ipsilateral breast recurrence. A prospective, multicenter, single arm Phase II design will evaluate the feasibility of repeated breast-conserving surgery combined with re- irradiation using IORT after local recurrence of breast carcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
surgery and Intra Operative Radiotherapy
Arm Type
Experimental
Arm Description
Surgery : Tumorectomy will be performed according to the current standards, obtaining "clear" margins. The axillary lymph node control will depend on the initial management (clinical and ultrasound) of these N0 patients, chosen by the teams. Intra Operative Radiotherapy (IORT): After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeam™) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure.
Intervention Type
Procedure
Intervention Name(s)
tumorectomy
Intervention Description
Tumorectomy will be performed according to the current standards, obtaining "clear" margins. The axillary lymph node control will depend on the initial management (clinical and ultrasound) of these N0 patients, chosen by the teams.
Intervention Type
Radiation
Intervention Name(s)
Intra Operative Radiotherapy
Intervention Description
After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeam™) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure
Primary Outcome Measure Information:
Title
The tolerance of RIOP (Intra Operative Radiotherapy) in patients with delayed local recurrences, after a second conservative treatment of breast cancer
Description
Fibrosis rate of RIOP grade 2 at 12 months of IORT (Intra Operative Radiotherapy) according to NCI CTCAE v4.0 classification
Time Frame
Up ti 12 months post radiation
Secondary Outcome Measure Information:
Title
Cosmetic outcome evaluated by photography
Description
A esthetic evaluation (photographs)
Time Frame
before treatment, at 15 days, at 3, 6, 12 and 24 months
Title
Rate of early and late toxicities
Description
Rate of Early toxicities (Hematoma, Lymphorrhea, Breast infection) Late toxicities (telangiectasia, breast pain, skin hyperpigmentation, skin ulceration, skin atrophy)
Time Frame
from the baseline to 5 years after treatment
Title
Local relapse-free survival
Description
Time from baseline to the apparition of local relapse
Time Frame
from the baseline to 5 years after treatment
Title
Metastasis relapse-free survival
Description
Time from baseline to the apparition of metastatic relapse
Time Frame
from the baseline to 5 years after treatment
Title
Disease-free survival.
Description
Time without relapse
Time Frame
from the baseline to 5 years after treatment
Title
Overall survival
Description
Time from baseline to the apparition of relapse
Time Frame
from the baseline to 5 years after treatment
Title
Free interval without mastectomy.
Description
Time from baseline to the mastectomy
Time Frame
from the baseline to 5 years after treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically proven non-lobular invasive breast recurrence Time from whole breast radiation following the initial lumpectomy >5 years Unifocal tumor Recurrent tumor size ≤ 2 cm Adequate breast size for a second breast-conserving surgery with acceptable cosmetic result Bilateral breast mammogram within 90 days prior to study entry Breast MRI within 90 days prior to study entry Histological grade I-II Estrogen-receptor-positive tumor (ER+) Cerb2-negative tumor N0 M0 Prior radiotherapy delivered within a standard fractionation schedule Performance status (ECOG) 0-1 Women ≥ 50 years -Absence of any psychological, familial, sociological, or geographical conditions with a potential to hamper compliance with the study and follow- up schedule Affiliated to the French Health Insurance regimen Written and signed informed consent form. Exclusion Criteria: Multifocal and/or multicenter recurrence Lobular carcinoma Estrogen-receptor-negative tumor (ER-) Cerb2 (her2) overexpressed - breast cancer Extensive intraductal component (EIC) on biopsy Lymph vessel invasion on biopsy N1-3 status: Regional cytological or histologically proven node recurrence M1 status: Metastatic disease cT4 (Skin or muscle involvement) or Paget's disease of the nipple Prior radiotherapy delivered within an accelerated or hypo-fraction schedule Prior malignancy other than non-melanoma skin cancer unless the patient has been disease free for at least 5 years Patients with a small breast volume, technically unsatisfactory for a second conservative surgery or intraoperative breast irradiation. Preoperative chemotherapy or hormone therapy for local relapse Connective tissue disease or scleroderma, contraindicating radiotherapy Known BRCA1/2 gene mutation (genetic testing is not required)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LEMANSKI Claire
Organizational Affiliation
Institut régional du Cancer - Val d'Aurelle
Official's Role
Study Chair
Facility Information:
Facility Name
Institut Bergonié
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Chu Brest
City
Brest
Country
France
Facility Name
Centre George Francois Leclerc
City
Dijon
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69
Country
France
Facility Name
CHU La TIMONE
City
Marseille
ZIP/Postal Code
13
Country
France
Facility Name
Institut Paoli Calmette
City
Marseille
ZIP/Postal Code
13
Country
France
Facility Name
ICM
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Institut de Cancérologie de l'Ouest
City
Nantes
Country
France

12. IPD Sharing Statement

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Intraoperative Radiotherapy After Local Recurrence in Breast Cancer

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