Intraoperative Radiotherapy After Local Recurrence in Breast Cancer

Breast Carcinoma Clinical Trial

— RE-IORT01  

Official title:

Feasibility Clinical Trial of Intraoperative Radiotherapy (IORT) and Second Breast-conserving-surgery After Local Recurrence of Breast Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02386371
• Other study ID #: ICM-URC2014/07
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: September 18, 2023

Study information

• Verified date: October 2023
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 18, 2023
• Est. primary completion date: June 12, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Carcinoma
• Recurrence

Intervention

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

Locations

Country	Name	City	State
France	Institut Bergonié	Bordeaux
France	Chu Brest	Brest
France	Centre George Francois Leclerc	Dijon
France	Centre Léon Bérard	Lyon
France	CHU La TIMONE	Marseille
France	Institut Paoli Calmette	Marseille
France	ICM	Montpellier
France	Institut de Cancérologie de l'Ouest	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

References & Publications (73)

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* Note: There are 73 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up ti 12 months post radiation
Secondary	Cosmetic outcome evaluated by photography	A esthetic evaluation (photographs)	before treatment, at 15 days, at 3, 6, 12 and 24 months
Secondary	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)	from the baseline to 5 years after treatment
Secondary	Local relapse-free survival	Time from baseline to the apparition of local relapse	from the baseline to 5 years after treatment
Secondary	Metastasis relapse-free survival	Time from baseline to the apparition of metastatic relapse	from the baseline to 5 years after treatment
Secondary	Disease-free survival.	Time without relapse	from the baseline to 5 years after treatment
Secondary	Overall survival	Time from baseline to the apparition of relapse	from the baseline to 5 years after treatment
Secondary	Free interval without mastectomy.	Time from baseline to the mastectomy	from the baseline to 5 years after treatment