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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2015 by Institut du Cancer de Montpellier - Val d'Aurelle.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Institut du Cancer de Montpellier - Val d'Aurelle
ClinicalTrials.gov Identifier:
NCT02386371
First received: March 2, 2015
Last updated: March 10, 2015
Last verified: March 2015
  Purpose
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.

Condition Intervention Phase
Breast Carcinoma
Procedure: tumorectomy
Radiation: Intra Operative Radiotherapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility Clinical Trial of Intraoperative Radiotherapy (IORT) and Second Breast-conserving-surgery After Local Recurrence of Breast Carcinoma

Resource links provided by NLM:


Further study details as provided by Institut du Cancer de Montpellier - Val d'Aurelle:

Primary Outcome Measures:
  • Tolerance of intra operative radiation as assessed by acute and late toxicities [ Time Frame: up to 5 years ]

Secondary Outcome Measures:
  • Cosmetic outcome evaluated by photography [ Time Frame: up to 5 years ]
    To


Estimated Enrollment: 51
Study Start Date: March 2014
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: surgery and Intra Operative Radiotherapy

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.

Procedure: tumorectomy
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.
Radiation: Intra Operative Radiotherapy
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

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.

  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02386371

Contacts
Contact: LEMANSKI CLAIRE +33467613102 claire.lemanski@icm.unicancer.fr

Locations
France
CRLC Val d'Aurelle Recruiting
Montpellier, France, 34298
Contact: claire LEMANSKI, MD    +33467613102    claire.lemanski@icm.unicancer.fr   
Principal Investigator: Claire LEMANSKI, MD         
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Investigators
Study Director: DOMERGUE Jacques Institut régional du Cancer - Val d'Aurelle
  More Information

Responsible Party: Institut du Cancer de Montpellier - Val d'Aurelle
ClinicalTrials.gov Identifier: NCT02386371     History of Changes
Other Study ID Numbers: ICM-URC2014/07
Study First Received: March 2, 2015
Last Updated: March 10, 2015

Additional relevant MeSH terms:
Carcinoma
Recurrence
Breast Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on March 28, 2017