Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03121469 |
| Other study ID # |
2016/65 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 25, 2018 |
| Est. completion date |
October 24, 2025 |
Study information
| Verified date |
November 2023 |
| Source |
Centre Antoine Lacassagne |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Phase 1/2 study, open, monocenter, non-randomized
Description:
Breast cancer, like the majority of cancers, has an incidence wich increased with age. Breast
cancer in elderly women from an age of more than 70 years is defined but even from the age of
60, a simplified conservative treatment appears to be of interest, It is reserved for well
selected tumors, small sizes, with low risk of local relapse.
In practice, the ratio of tumor to breast volume optimizes the selection of patients who can
benefit from conservative treatment.
Standard conservative treatment is represented by tumorectomy (with axillary or sentinel
lymph node) associated with irradiation of the entire breast. A dose of 60 Grays in 6 weeks
is considered as standard.
To reduce radiation therapy, accelerated partial irradiation of the breast (IPAS) is a widely
explored research pathway with several technical options. Among these IPAS techniques,
per-operative radiotherapy (RPO) is an alternative that can be performed by various
techniques: electrontherapy or by X-rays of 50 Kv, or even by MammositeTM or interstitial
brachytherapy but in this case with an irradiation carried out at a distance from the
intervention which has been used to set up the vectors to carry out this irradiation
secondarily.
Currently, 7 randomized trials tested the results of IPAS, including 2 in perioperative ELIOT
(Electron Intraoperative therapy) and TARGIT A (Targeted intraoperative radiotherapy.
The TARGIT trial started in 2003 recruited 1730 patients in the total breast irradiation arm
(ITS) and 1721 patients in the partial irradiation arm (IPAS). It is a worldwide recruitment
on 5 continents. It compares for the T1N0 stages after 50 years a standard treatment
(tumorectomy associated with axillary node exploration and spreading irradiation: 60 Gy / 6
weeks) to per-operative radiotherapy delivering with the IntrabeamTM 50 Kv a dose of 20 Gy In
30 minutes at the surface of the tumor excision cavity. The results show, with a median
follow-up of 60 months, that there are significantly more local relapses in the IPAS arm
(1.3% vs 3.3%, p = 0.042) but that if RPO is performed during surgical time Not deferred) the
rate of local relapse is only 2.1%. There was no difference in overall survival and mortality
from intercurrent disease was lower in the RPO group. The results of F Wenz and the German
teams published recently at the DEGRO German Congress show that for the 185 patients included
in Mannheim in the TARGIT A trial there is no local relapse at 5 years in the arm RPO and
that the G3 toxicity rate is <5%. For patients included in the TARGIT E trial (patients> 70
years) out of 273 patients treated in 20 German centers, there was 1 local relapse and no
severe toxicity. (Strahl 2016). The rate of patients in Germany requiring external
radiotherapy is less than 3%; Indicating a good selection of patients and appropriate
treatment.
In Germany and Spain the RPO 50 Kv of the breast is admitted to the financial assumption by
the insurance companies. In France, a recent report (May 2016) of the HAS considers that the
rendered medical service of the RPO is still not validated and that this technique must
always be carried out within a framework of clinical research which justifies the present
study.
Alternative to Intrabeam TM. The Philips RT50TM x 50 KV radiotherapy radiotherapy device,
introduced in 1948, has been used to treat skin, eyelid and rectal cancers. It could be used
for breast cancer RPO to irradiate the areola-nipple plaque (MAP) after total subcutaneous
mastectomy retaining PAM. Since this device is no longer manufactured, a new 50 KV device,
Papillon 50TM has been used since 2009 in 10 centers in Europe (France, UK, Sweden, Denmark
and Switzerland) with good results and a good tolerance in cancers of the Rectum, skin and
eyelids. In 2010, the Center Antoine Lacassagne was awarded a research contract by the French
National Research Agency (ANR) to develop and evaluate applicators to irradiate various
tumors (skin, rectum, vagina). With the PAPILLON 50 BTM device, during the year 2011, the
surgeons in the surgery of an applicator irradiating the tumoral area of excision on a volume
of two thirds of sphere, made it possible for surgeons Center Antoine Lacassagne to note a
good coverage of the tissues at risk of residual disease. In the TARGIT test, the Intrabeam ™
irradiates a practically spherical volume. The good results of the TARGIT test and the
argument of a large volume irradiated cells have justified an evolution of the Papillon 50 ™
device.
A specific applicator was designed and tested between 2010 and 2012 to realize an RPO in
breast cancer: Applicator NBA (Nice Breast Applicator) who obtained a European patent held by
the Center Antoine Lacassagne.
In October 2016 ARIANE put on the market a device (Papillon + TM) which, thanks to an
original X-ray tube and using the NBA applicator, irradiates satisfactorily (310 °) Resection
after lumpectomy. This irradiation is comparable to that achieved by the Intrabeam apparatus.
The advantage of the Papillon + TM device is its high dose rate, which can deliver the dose
of 20 Gy (to the surface of the NBA applicator) in 2 to 4 minutes instead of 30 minutes using
the Intrabeam technique .
Moreover, in view of the results of the TARGIT A trial, it is necessary to add to our RPO
protocol, post-operative radiotherapy of the whole breast depending on whether the final
histological result is in favor of an intermediate risk of relapse.
In the absence of adjuvant chemotherapy, postoperative radiotherapy will be started within 5
to 8 weeks after surgery.
The aim of this clinical research is to validate the use of the PAPILLON + TM device for the
RPO of small breast cancers in patients over 60 years.
