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Per-Operative Radiotherapy by Papillon +TM in Localized Breast Cancer

ConditionLocalized Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age65+
SponsorCentre Antoine Lacassagne

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Per-Operative Radiotherapy technique by Papillon +TM

    Radiation

    20Gy Per-Operative Radiotherapy technique by Papillon +TM, on localized breast cancer

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Per-Operative Radiotherapy technique by Papillon +TMExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
up to 6 months

Secondary outcomes

1

global tolerance of per-operative radiotherapy

global safety (assessed by CTCAE V5.0) of per-operative radiotherapy

Time frame
up to 5 years
2

local disease free survival at 5 years of per-operative radiotherapy

To evaluate local disease free survival at 5 years of per-operative radiotherapy

Time frame
up to 5 years
3

disease free survival at 5 years of per-operative radiotherapy

To evaluate disease free survival at 5 years of per-operative radiotherapy

Time frame
up to 5 years
4

quality of life of patients

QLQ-C30 and QLQ BR-23 EORTC questionnaires

Time frame
up to 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Antoine Lacassagne

Lead sponsor

Source ClinicalTrials.gov
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