Intraoperative Radiotherapy After Local Recurrence in Breast Cancer (RE-IORT01)
Recruitment status was: Recruiting
|Breast Carcinoma||Procedure: tumorectomy Radiation: Intra Operative Radiotherapy||Phase 2|
|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|
- Tolerance of intra operative radiation as assessed by acute and late toxicities [ Time Frame: up to 5 years ]
- Cosmetic outcome evaluated by photography [ Time Frame: up to 5 years ]To
|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)|
Experimental: surgery and Intra Operative Radiotherapy
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.
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02386371
|Contact: LEMANSKI CLAIREfirstname.lastname@example.org|
|CRLC Val d'Aurelle||Recruiting|
|Montpellier, France, 34298|
|Contact: claire LEMANSKI, MD +33467613102 email@example.com|
|Principal Investigator: Claire LEMANSKI, MD|
|Study Director:||DOMERGUE Jacques||Institut régional du Cancer - Val d'Aurelle|