Clinical trial · Interventional
Intraoperative Radiotherapy After Local Recurrence in Breast Cancer
Feasibility Clinical Trial of Intraoperative Radiotherapy (IORT) and Second Breast-conserving-surgery After Local Recurrence of Breast Carcinoma
NCT02386371CI-TRIAL-00085607RE-IORT01completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intra Operative Radiotherapy | Radiation | — | UNRESOLVED |
| tumorectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- surgery and Intra Operative Radiotherapy
- 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.
- interventionNames
- Procedure: tumorectomy
- Radiation: Intra Operative Radiotherapy
Primary outcomes (1)
- measure
- The Tolerance of RIOP (Intra Operative Radiotherapy) in Patients With Delayed Local Recurrences, After a Second Conservative Treatment of Breast Cancer
- timeFrame
- Up to 12 months post radiation
- description
- Fibrosis rate of RIOP grade 2 at 12 months of IORT (Intra Operative Radiotherapy) according to NCI CTCAE v4.0 classification grade 0 is the better outcomes Grade \>= 2 is the worse outcomes
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
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)
References
Publications (74)
- BACKGROUNDFisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41. doi: 10.1056/NEJMoa022152. PMID 12393820
- BACKGROUNDVeronesi U, Cascinelli N, Mariani L, Greco M, Saccozzi R, Luini A, Aguilar M, Marubini E. Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med. 2002 Oct 17;347(16):1227-32. doi: 10.1056/NEJMoa020989. PMID 12393819
- BACKGROUNDBrewster AM, Hortobagyi GN, Broglio KR, Kau SW, Santa-Maria CA, Arun B, Buzdar AU, Booser DJ, Valero V, Bondy M, Esteva FJ. Residual risk of breast cancer recurrence 5 years after adjuvant therapy. J Natl Cancer Inst. 2008 Aug 20;100(16):1179-83. doi: 10.1093/jnci/djn233. Epub 2008 Aug 11. PMID 18695137
- BACKGROUNDPanet-Raymond V, Truong PT, Alexander C, Lesperance M, McDonald RE, Watson PH. Clinicopathologic factors of the recurrent tumor predict outcome in patients with ipsilateral breast tumor recurrence. Cancer. 2011 May 15;117(10):2035-43. doi: 10.1002/cncr.25767. Epub 2010 Nov 29. PMID 21523714
- BACKGROUNDEarly Breast Cancer Trialists' Collaborative Group (EBCTCG); Darby S, McGale P, Correa C, Taylor C, Arriagada R, Clarke M, Cutter D, Davies C, Ewertz M, Godwin J, Gray R, Pierce L, Whelan T, Wang Y, Peto R. Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10,801 women in 17 randomised trials. Lancet. 2011 Nov 12;378(9804):1707-16. doi: 10.1016/S0140-6736(11)61629-2. Epub 2011 Oct 19. PMID 22019144
- BACKGROUNDKurtz JM, Spitalier JM, Amalric R, Brandone H, Ayme Y, Jacquemier J, Hans D, Bressac C. The prognostic significance of late local recurrence after breast-conserving therapy. Int J Radiat Oncol Biol Phys. 1990 Jan;18(1):87-93. doi: 10.1016/0360-3016(90)90271-k.