NCT04680715RecruitingPhase 2
Per-Operative Radiotherapy (RPO) by Papillon +TM in Localized Breast Cancer : Faisability and Toxicity Study
Centre Antoine Lacassagne2 sites in 1 country40 target enrollmentStarted: July 16, 2021Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Centre Antoine Lacassagne
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- early toxicities occuring until 6 months after performing per-operative radiotherapy
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Per-Operative Radiotherapy technique by Papillon +TM
Experimental
Per-Operative Radiotherapy (1x20Gy) technique by Papillon +TM
Intervention: Per-Operative Radiotherapy technique by Papillon +TM (Radiation)
Outcomes
Primary Outcomes
early toxicities occuring until 6 months after performing per-operative radiotherapy
Time Frame: up to 6 months
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
Secondary Outcomes
- global tolerance of per-operative radiotherapy(up to 5 years)
- disease free survival at 5 years of per-operative radiotherapy(up to 5 years)
- quality of life of patients(up to 6 months)
- local disease free survival at 5 years of per-operative radiotherapy(up to 5 years)
Investigators
Study Sites (2)
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