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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 (Intrabeamâ„¢) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tumorectomy | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 12 months post radiation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | from the baseline to 5 years after treatment |
| Local Relapse-free Survival |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| LEMANSKI Claire | Institut régional du Cancer - Val d'Aurelle | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonié | Bordeaux | 33000 | France | |||
| Chu Brest |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12393820 | Background | 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. | |
| 12393819 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 (Intrabeamâ„¢) will be administered in tumor bed. The addition of IORT does not modify the surgical 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. Intra Operative Radiotherapy: After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeamâ„¢) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 (Intrabeamâ„¢) will be administered in tumor bed. The addition of IORT does not modify the surgical 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. Intra Operative Radiotherapy: After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeamâ„¢) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 grade 0 is the better outcomes Grade >= 2 is the worse outcomes | Posted | Number | participants | Up to 12 months post radiation |
|
adverse event were collected from baseline to 5 years after the surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 (Intrabeamâ„¢) will be administered in tumor bed. The addition of IORT does not modify the surgical 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. Intra Operative Radiotherapy: After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeamâ„¢) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| lumbosacral radiculopathy | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hearing and inner ear disorder | Ear and labyrinth disorders | CTCAE (4.0) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mme Aurore Moussion, Director of Direction of Clinical Research and Innovation | INSTITUT REGIONAL DU CANCER DE MONTPELLIER Cancer de Montpellier | 0467613102 | +33 | drci-icm105@icm.unicancer.fr |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 26, 2017 | Jul 9, 2024 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
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| Intra Operative Radiotherapy | Radiation | After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeamâ„¢) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure |
|
Number of patient with or without the apparition of local relapse |
| from the baseline to 5 years after treatment |
| Metastasis Relapse-free Survival | number of patient with and without the apparition of metastatic relapse. | from the baseline to 5 years after treatment |
| Disease-free Survival. | Number of patient with and without a relapse | from the baseline to 5 years after treatment |
| Overall Survival | number de patient dead | from the baseline to 5 years after treatment |
| Free Interval Without Mastectomy. | Number of patient with a mastectomy during the study and follow up | from the baseline to 5 years after treatment |
| Brest |
| France |
| Centre George Francois Leclerc | Dijon | France |
| Centre Léon Bérard | Lyon | 69 | France |
| CHU La TIMONE | Marseille | 13 | France |
| Institut Paoli Calmette | Marseille | 13 | France |
| ICM | Montpellier | 34298 | France |
| Institut de Cancérologie de l'Ouest | Nantes | France |
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| 42001960 | Derived | Lemanski C, Houvenaeghel G, Gourgou S, Gutowski M, Fournier M, Racadot S, Blanc-Onfroy ML, Martin E, Pradier O, Hennequin C, Tallet A, Morel A, Azria D, Bourgier C. Feasibility and safety of repeat breast-conserving surgery with intraoperative irradiation for local breast carcinoma recurrences: A phase 2 trial. Radiother Oncol. 2026 Jul;220:111538. doi: 10.1016/j.radonc.2026.111538. Epub 2026 Apr 17. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| 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) grade 0 is the better outcomes | Posted | Count of Participants | Participants | from the baseline to 5 years after treatment |
|
|
|
| Secondary | Local Relapse-free Survival | Number of patient with or without the apparition of local relapse | Posted | Count of Participants | Participants | from the baseline to 5 years after treatment |
|
|
|
| Secondary | Metastasis Relapse-free Survival | number of patient with and without the apparition of metastatic relapse. | Posted | Count of Participants | Participants | from the baseline to 5 years after treatment |
|
|
|
| Secondary | Disease-free Survival. | Number of patient with and without a relapse | Posted | Count of Participants | Participants | from the baseline to 5 years after treatment |
|
|
|
| Secondary | Overall Survival | number de patient dead | only 53 patients analysable for this objective | Posted | Number | participants | from the baseline to 5 years after treatment |
|
|
|
| Secondary | Free Interval Without Mastectomy. | Number of patient with a mastectomy during the study and follow up | number of patient with mastectomy | Posted | Number | participants | from the baseline to 5 years after treatment |
|
|
|
| 6 |
| 59 |
| 3 |
| 59 |
| 59 |
| 59 |
| postoperative wound infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| mastitis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| visual system disorder | Eye disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| gastrointestinal disorders | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| general disorders and reaction at the site of administration | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Infections and infestations | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| medical exams | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| metabolism and nutrition disorders | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| nervous system disorder | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| psychiatric disorders | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| renal and urinary disorders | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| reproductive system and breast disorders | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| surgical ann medical procedures | Surgical and medical procedures | CTCAE (4.0) | Non-systematic Assessment |
|
| vascular disorders | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| grade 3 |
|
| Missing data |
|
| Early toxicities |
|
| Late toxicities |
|