Breast CarcinomaRE-IORT01NCT02386371
Intraoperative Radiotherapy After Local Recurrence in Breast Cancer
A study testing tumorectomy and Intra Operative Radiotherapy in people with Breast Carcinoma, run by Institut du Cancer de Montpellier - Val d'Aurelle at 8 sites in France.
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. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- tumorectomy and Intra Operative Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 8 sitesFrance
- Study dates
- Mar 2014to 18 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Institut Bergonié
Bordeaux, 33000
Chu Brest
Brest
Centre George Francois Leclerc
Dijon
Centre Léon Bérard
Lyon, 69
CHU La TIMONE
Marseille, 13
Institut Paoli Calmette
Marseille, 13
ICM
Montpellier, 34298
Institut de Cancérologie de l'Ouest
Nantes
About this study
Official title: Feasibility Clinical Trial of Intraoperative Radiotherapy (IORT) and Second Breast-conserving-surgery After Local Recurrence of Breast Carcinoma
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.
Read the 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.
- Conditions
- Breast Carcinoma
- Being tested
- tumorectomy, Intra Operative Radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tumorectomyProcedure or 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 RadiotherapyRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| surgery and Intra Operative Radiotherapy | Experimental | 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. Receives: Procedure: tumorectomy; Radiation: Intra Operative Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 grade 0 is the better outcomes Grade >= 2 is the worse outcomes
Measured: Up to 12 months post radiation
Secondary outcomes (6)
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) grade 0 is the better outcomes
Measured: from the baseline to 5 years after treatment
Local Relapse-free Survival
Number of patient with or without the apparition of local relapse
Measured: from the baseline to 5 years after treatment
Metastasis Relapse-free Survival
number of patient with and without the apparition of metastatic relapse.
Measured: from the baseline to 5 years after treatment
Disease-free Survival.
Number of patient with and without a relapse
Measured: from the baseline to 5 years after treatment
Overall Survival
number de patient dead
Measured: from the baseline to 5 years after treatment
Free Interval Without Mastectomy.
Number of patient with a mastectomy during the study and follow up
Measured: from the baseline to 5 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startMar 2014
- Primary completion12 Jun 2020
- Study completion18 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (74)Papers the sponsor has linked to this study.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LEMANSKI Claire, Study chair, Institut régional du Cancer - Val d'Aurelle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386371
- Sponsor's protocol ID
- ICM-URC2014/07
- Acronym
- RE-IORT01
- Status last verified
- Feb 2025
- First submitted
- 2 Mar 2015
- Last updated
- 6 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Fisher 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.
PubMed 12393820Veronesi 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.
PubMed 12393819Brewster 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.
PubMed 18695137Panet-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.
PubMed 21523714Early 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.
PubMed 22019144Kurtz 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.
PubMed 2298639Hannoun-Levi JM, Resch A, Gal J, Kauer-Dorner D, Strnad V, Niehoff P, Loessl K, Kovacs G, Van Limbergen E, Polgar C; GEC-ESTRO Breast Cancer Working Group. Accelerated partial breast irradiation with interstitial brachytherapy as second conservative treatment for ipsilateral breast tumour recurrence: multicentric study of the GEC-ESTRO Breast Cancer Working Group. Radiother Oncol. 2013 Aug;108(2):226-31. doi: 10.1016/j.radonc.2013.03.026. Epub 2013 May 3.
PubMed 23647758Moran MS, Haffty BG. Local-regional breast cancer recurrence: prognostic groups based on patterns of failure. Breast J. 2002 Mar-Apr;8(2):81-7. doi: 10.1046/j.1524-4741.2002.08202.x.
PubMed 11896752Fourquet A, Campana F, Zafrani B, Mosseri V, Vielh P, Durand JC, Vilcoq JR. Prognostic factors of breast recurrence in the conservative management of early breast cancer: a 25-year follow-up. Int J Radiat Oncol Biol Phys. 1989 Oct;17(4):719-25. doi: 10.1016/0360-3016(89)90057-6.
PubMed 2777661Fisher B, Anderson S, Fisher ER, Redmond C, Wickerham DL, Wolmark N, Mamounas EP, Deutsch M, Margolese R. Significance of ipsilateral breast tumour recurrence after lumpectomy. Lancet. 1991 Aug 10;338(8763):327-31. doi: 10.1016/0140-6736(91)90475-5.
PubMed 1677695Veronesi U, Marubini E, Del Vecchio M, Manzari A, Andreola S, Greco M, Luini A, Merson M, Saccozzi R, Rilke F, et al. Local recurrences and distant metastases after conservative breast cancer treatments: partly independent events. J Natl Cancer Inst. 1995 Jan 4;87(1):19-27. doi: 10.1093/jnci/87.1.19.
PubMed 7666458Tanis E, van de Velde CJ, Bartelink H, van de Vijver MJ, Putter H, van der Hage JA. Locoregional recurrence after breast-conserving therapy remains an independent prognostic factor even after an event free interval of 10 years in early stage breast cancer. Eur J Cancer. 2012 Aug;48(12):1751-6. doi: 10.1016/j.ejca.2012.02.051. Epub 2012 Mar 23.
PubMed 22446021Schmoor C, Sauerbrei W, Bastert G, Schumacher M. Role of isolated locoregional recurrence of breast cancer: results of four prospective studies. J Clin Oncol. 2000 Apr;18(8):1696-708. doi: 10.1200/JCO.2000.18.8.1696.
PubMed 10764430Anderson SJ, Wapnir I, Dignam JJ, Fisher B, Mamounas EP, Jeong JH, Geyer CE Jr, Wickerham DL, Costantino JP, Wolmark N. Prognosis after ipsilateral breast tumor recurrence and locoregional recurrences in patients treated by breast-conserving therapy in five National Surgical Adjuvant Breast and Bowel Project protocols of node-negative breast cancer. J Clin Oncol. 2009 May 20;27(15):2466-73. doi: 10.1200/JCO.2008.19.8424. Epub 2009 Apr 6.
PubMed 19349544van der Sangen MJ, van de Poll-Franse LV, Roumen RM, Rutten HJ, Coebergh JW, Vreugdenhil G, Voogd AC. The prognosis of patients with local recurrence more than five years after breast conservation therapy for invasive breast carcinoma. Eur J Surg Oncol. 2006 Feb;32(1):34-8. doi: 10.1016/j.ejso.2005.10.005. Epub 2005 Nov 21.
PubMed 16305821
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Clinical Trial of Intraoperative Radiotherapy (IORT) and Second Breast-conserving-surgery After Local Recurrence of Breast Carcinoma
- ClinicalTrials.gov ID
- NCT02386371
- Acronym / sponsor ID
- RE-IORT01 / ICM-URC2014/07
- Conditions
- Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- 12 Jun 2020 (actual)
- Study completion
- 18 Sep 2023 (actual)
- First posted
- 11 Mar 2015 (estimated)
- Results
- Posted 6 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surgery and Intra Operative Radiotherapy | Experimental | Procedure: tumorectomy, Radiation: Intra Operative RadiotherapySurgery : 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (15 listed)
- Multifocal and/or multicenter recurrence
- Lobular carcinoma
- Estrogen-receptor-negative tumor (ER-)
- Cerb2 (her2) overexpressed - breast cancer
- Extensive intraductal component (EIC) on biopsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tumorectomyTumorectomy 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. | Procedure or surgery | surgery and Intra Operative Radiotherapy |
| Intra Operative RadiotherapyAfter 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 | Radiation | surgery and Intra Operative Radiotherapy |
Primary outcome
The Tolerance of RIOP (Intra Operative Radiotherapy) in Patients With Delayed Local Recurrences, After a Second Conservative Treatment of Breast Cancer
Time frame: Up to 12 months post radiation
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
6 secondary outcomes
Rate of Early and Late Toxicities
Time frame: from the baseline to 5 years after treatment
Local Relapse-free Survival
Time frame: from the baseline to 5 years after treatment
Metastasis Relapse-free Survival
Time frame: from the baseline to 5 years after treatment
Disease-free Survival.
Time frame: from the baseline to 5 years after treatment
Overall Survival
Time frame: from the baseline to 5 years after treatment
Free Interval Without Mastectomy.
Time frame: from the baseline to 5 years after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12393820Fisher 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.
- Background: PubMed 12393819Veronesi 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.
- Background: PubMed 18695137Brewster 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.
- Background: PubMed 21523714Panet-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.
- Background: PubMed 22019144Early 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.
- Background: PubMed 2298639Kurtz 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.
- Background: PubMed 23647758Hannoun-Levi JM, Resch A, Gal J, Kauer-Dorner D, Strnad V, Niehoff P, Loessl K, Kovacs G, Van Limbergen E, Polgar C; GEC-ESTRO Breast Cancer Working Group. Accelerated partial breast irradiation with interstitial brachytherapy as second conservative treatment for ipsilateral breast tumour recurrence: multicentric study of the GEC-ESTRO Breast Cancer Working Group. Radiother Oncol. 2013 Aug;108(2):226-31. doi: 10.1016/j.radonc.2013.03.026. Epub 2013 May 3.
- Background: PubMed 11896752Moran MS, Haffty BG. Local-regional breast cancer recurrence: prognostic groups based on patterns of failure. Breast J. 2002 Mar-Apr;8(2):81-7. doi: 10.1046/j.1524-4741.2002.08202.x.
- Background: PubMed 2777661Fourquet A, Campana F, Zafrani B, Mosseri V, Vielh P, Durand JC, Vilcoq JR. Prognostic factors of breast recurrence in the conservative management of early breast cancer: a 25-year follow-up. Int J Radiat Oncol Biol Phys. 1989 Oct;17(4):719-25. doi: 10.1016/0360-3016(89)90057-6.
- Background: PubMed 1677695Fisher B, Anderson S, Fisher ER, Redmond C, Wickerham DL, Wolmark N, Mamounas EP, Deutsch M, Margolese R. Significance of ipsilateral breast tumour recurrence after lumpectomy. Lancet. 1991 Aug 10;338(8763):327-31. doi: 10.1016/0140-6736(91)90475-5.
- Background: PubMed 7666458Veronesi U, Marubini E, Del Vecchio M, Manzari A, Andreola S, Greco M, Luini A, Merson M, Saccozzi R, Rilke F, et al. Local recurrences and distant metastases after conservative breast cancer treatments: partly independent events. J Natl Cancer Inst. 1995 Jan 4;87(1):19-27. doi: 10.1093/jnci/87.1.19.
- Background: PubMed 22446021Tanis E, van de Velde CJ, Bartelink H, van de Vijver MJ, Putter H, van der Hage JA. Locoregional recurrence after breast-conserving therapy remains an independent prognostic factor even after an event free interval of 10 years in early stage breast cancer. Eur J Cancer. 2012 Aug;48(12):1751-6. doi: 10.1016/j.ejca.2012.02.051. Epub 2012 Mar 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LEMANSKI Claire study chair
Institut régional du Cancer - Val d'Aurelle
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tumorectomy and Intra Operative Radiotherapy in people with Breast Carcinoma, run by Institut du Cancer de Montpellier - Val d'Aurelle at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Tolerance of RIOP (Intra Operative Radiotherapy) in Patients With Delayed Local Recurrences, After a Second Conservative Treatment of Breast Cancer (time frame: Up to 12 months post radiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02386371, which also lists 74 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.