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Phase II study; open recruitment, multicentrique. The aim of this clinical research is to evaluate faisability and toxicity of the per-operative radiotherapy using PAPILLON + TM device for localized breast cancers patients over 65 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Per-Operative Radiotherapy technique by Papillon +TM | Experimental | Per-Operative Radiotherapy (1x20Gy) technique by Papillon +TM |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Per-Operative Radiotherapy technique by Papillon +TM | Radiation | 20Gy Per-Operative Radiotherapy technique by Papillon +TM, on localized breast cancer |
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| Measure | Description | Time Frame |
|---|---|---|
| early toxicities occuring until 6 months after performing per-operative radiotherapy | pourcentage of patient with toxicities of grade 3 and more (by CTCAE v5.0) related to per-operative radiotherapy and that occured until 6 months after performing | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| global tolerance of per-operative radiotherapy | global safety (assessed by CTCAE V5.0) of per-operative radiotherapy | up to 5 years |
| local disease free survival at 5 years of per-operative radiotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frédérique JACQUINOT | Contact | 04 92 03 10 24 | +33 | drci-promotion@nice.unicancer.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pôle Santé République | Not yet recruiting | Clermont-Ferrand | 63000 | France |
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radiotherapy treatment
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To evaluate local disease free survival at 5 years of per-operative radiotherapy
| up to 5 years |
| disease free survival at 5 years of per-operative radiotherapy | To evaluate disease free survival at 5 years of per-operative radiotherapy | up to 5 years |
| quality of life of patients | QLQ-C30 and QLQ BR-23 EORTC questionnaires | up to 6 months |
| Centre Antoine Lacassagne | Recruiting | Nice | 06189 | France |
|