Recruiting NCT04680715
Per-Operative Radiotherapy by Papillon +TM in Localized Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Per-Operative Radiotherapy technique by Papillon +TM.
- Who it may be relevant to
- Registry conditions: Localized Breast Cancer. Basic parameters: from 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Per-Operative Radiotherapy (RPO) by Papillon +TM in Localized Breast Cancer : Faisability and Toxicity Study
Overview
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.
Interventions
- Radiation Per-Operative Radiotherapy technique by Papillon +TM
20Gy Per-Operative Radiotherapy technique by Papillon +TM, on localized breast cancer
Primary outcome measures
- early toxicities occuring until 6 months after performing per-operative radiotherapy [Time frame: up to 6 months]
Secondary outcome measures (4)
- global tolerance of per-operative radiotherapy [Time frame: up to 5 years]
- local disease free survival at 5 years of per-operative radiotherapy [Time frame: up to 5 years]
- disease free survival at 5 years of per-operative radiotherapy [Time frame: up to 5 years]
- quality of life of patients [Time frame: up to 6 months]
Eligibility criteria
Inclusion criteria
- Patient with invasive ductal adenocarcinoma <=2cm, evaluate on all radiological exams;
- Women aged 65 years or older (patients 65 years of age in the year may be included);
- Grade 1 or 2 unifocal adenocarcinoma, all index KI67, positive HR, negative HER2 status;
- T0 or T1, N0 radio-clinic;
- Operable patient with breast volume compatible with conservative surgery;
- Patient with prior malignancy or other concurrent malignancies are eligible, including bilateral breast cancer
- Patients who have been made aware of the information sheet and have given their written signed informed consent;
- Patients benefitting from social health insurance coverage
Exclusion criteria
- Age less than 65 years (except if 65 years obtained during the year)
- Patient with an exclusive in situ carcinoma
- Patient with lymphatic invasion / peri-nerve involvement / vascular emboli
- Patient with a lobular adenocarcinoma
- Patient with metastatic disease
- Multifocal tumor
- Patient with grade 3 or N+ disease
- N1 proved by ultrasound guided
- patient unable to express her consent
- Patient deprived placed under the authority of a tutor
- Female patients who are pregnant or breastfeeding
- Vulnerable patient: as defined in article L1121-5 à -8
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 2 centers
- Pôle Santé République — Clermont-Ferrand
- Centre Antoine Lacassagne — Nice
Identifiers
NCT: NCT04680715 · 2020/33