Trial Outcomes & Findings for Intraoperative Radiotherapy After Local Recurrence in Breast Cancer (NCT NCT02386371)
NCT ID: NCT02386371
Last Updated: 2025-02-06
Results Overview
Fibrosis rate of RIOP grade 2 at 12 months of IORT (Intra Operative Radiotherapy) according to NCI CTCAE v4.0 classification grade 0 is the better outcomes Grade \>= 2 is the worse outcomes
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
Up to 12 months post radiation
Results posted on
2025-02-06
Participant Flow
Participant milestones
| Measure |
Surgery and Intra Operative Radiotherapy
Surgery :
Tumorectomy will be performed according to the current standards, obtaining "clear" margins. The axillary lymph node control will depend on the initial management (clinical and ultrasound) of these N0 patients, chosen by the teams.
Intra Operative Radiotherapy (IORT):
After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeam™) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure.
tumorectomy: Tumorectomy will be performed according to the current standards, obtaining "clear" margins. The axillary lymph node control will depend on the initial management (clinical and ultrasound) of these N0 patients, chosen by the teams.
Intra Operative Radiotherapy: After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeam™) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure
|
|---|---|
|
Overall Study
STARTED
|
66
|
|
Overall Study
COMPLETED
|
53
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Surgery and Intra Operative Radiotherapy
n=53 Participants
Surgery :
Tumorectomy will be performed according to the current standards, obtaining "clear" margins. The axillary lymph node control will depend on the initial management (clinical and ultrasound) of these N0 patients, chosen by the teams.
Intra Operative Radiotherapy (IORT):
After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeam™) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure.
tumorectomy: Tumorectomy will be performed according to the current standards, obtaining "clear" margins. The axillary lymph node control will depend on the initial management (clinical and ultrasound) of these N0 patients, chosen by the teams.
Intra Operative Radiotherapy: After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeam™) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure
|
|---|---|
|
Age, Continuous
|
68 years
n=53 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=53 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=53 Participants
|
PRIMARY outcome
Timeframe: Up to 12 months post radiationFibrosis rate of RIOP grade 2 at 12 months of IORT (Intra Operative Radiotherapy) according to NCI CTCAE v4.0 classification grade 0 is the better outcomes Grade \>= 2 is the worse outcomes
Outcome measures
| Measure |
Surgery and Intra Operative Radiotherapy
n=53 Participants
Surgery :
Tumorectomy will be performed according to the current standards, obtaining "clear" margins. The axillary lymph node control will depend on the initial management (clinical and ultrasound) of these N0 patients, chosen by the teams.
Intra Operative Radiotherapy (IORT):
After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeam™) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure.
tumorectomy: Tumorectomy will be performed according to the current standards, obtaining "clear" margins. The axillary lymph node control will depend on the initial management (clinical and ultrasound) of these N0 patients, chosen by the teams.
Intra Operative Radiotherapy: After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeam™) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure
|
|---|---|
|
The Tolerance of RIOP (Intra Operative Radiotherapy) in Patients With Delayed Local Recurrences, After a Second Conservative Treatment of Breast Cancer
number of patients without fibrosis
|
34 participants
|
|
The Tolerance of RIOP (Intra Operative Radiotherapy) in Patients With Delayed Local Recurrences, After a Second Conservative Treatment of Breast Cancer
number of patients with fibrosis
|
19 participants
|
SECONDARY outcome
Timeframe: from the baseline to 5 years after treatmentRate of Early toxicities (Hematoma, Lymphorrhea, Breast infection) Late toxicities (telangiectasia, breast pain, skin hyperpigmentation, skin ulceration, skin atrophy) grade 0 is the better outcomes
Outcome measures
| Measure |
Surgery and Intra Operative Radiotherapy
n=59 Participants
Surgery :
Tumorectomy will be performed according to the current standards, obtaining "clear" margins. The axillary lymph node control will depend on the initial management (clinical and ultrasound) of these N0 patients, chosen by the teams.
Intra Operative Radiotherapy (IORT):
After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeam™) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure.
tumorectomy: Tumorectomy will be performed according to the current standards, obtaining "clear" margins. The axillary lymph node control will depend on the initial management (clinical and ultrasound) of these N0 patients, chosen by the teams.
Intra Operative Radiotherapy: After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeam™) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure
|
|---|---|
|
Rate of Early and Late Toxicities
global toxicities · grade 0
|
4 Participants
|
|
Rate of Early and Late Toxicities
global toxicities · grade 1
|
18 Participants
|
|
Rate of Early and Late Toxicities
global toxicities · grade 2
|
27 Participants
|
|
Rate of Early and Late Toxicities
global toxicities · grade 3
|
10 Participants
|
|
Rate of Early and Late Toxicities
global toxicities · Missing data
|
0 Participants
|
|
Rate of Early and Late Toxicities
Early toxicities · grade 0
|
12 Participants
|
|
Rate of Early and Late Toxicities
Early toxicities · grade 1
|
24 Participants
|
|
Rate of Early and Late Toxicities
Early toxicities · grade 2
|
17 Participants
|
|
Rate of Early and Late Toxicities
Early toxicities · grade 3
|
4 Participants
|
|
Rate of Early and Late Toxicities
Early toxicities · Missing data
|
2 Participants
|
|
Rate of Early and Late Toxicities
Late toxicities · grade 0
|
5 Participants
|
|
Rate of Early and Late Toxicities
Late toxicities · grade 1
|
18 Participants
|
|
Rate of Early and Late Toxicities
Late toxicities · grade 2
|
24 Participants
|
|
Rate of Early and Late Toxicities
Late toxicities · grade 3
|
8 Participants
|
|
Rate of Early and Late Toxicities
Late toxicities · Missing data
|
4 Participants
|
SECONDARY outcome
Timeframe: from the baseline to 5 years after treatmentNumber of patient with or without the apparition of local relapse
Outcome measures
| Measure |
Surgery and Intra Operative Radiotherapy
n=53 Participants
Surgery :
Tumorectomy will be performed according to the current standards, obtaining "clear" margins. The axillary lymph node control will depend on the initial management (clinical and ultrasound) of these N0 patients, chosen by the teams.
Intra Operative Radiotherapy (IORT):
After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeam™) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure.
tumorectomy: Tumorectomy will be performed according to the current standards, obtaining "clear" margins. The axillary lymph node control will depend on the initial management (clinical and ultrasound) of these N0 patients, chosen by the teams.
Intra Operative Radiotherapy: After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeam™) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure
|
|---|---|
|
Local Relapse-free Survival
patient with a local relapse
|
2 Participants
|
|
Local Relapse-free Survival
patients without local relapse
|
51 Participants
|
SECONDARY outcome
Timeframe: from the baseline to 5 years after treatmentnumber of patient with and without the apparition of metastatic relapse.
Outcome measures
| Measure |
Surgery and Intra Operative Radiotherapy
n=53 Participants
Surgery :
Tumorectomy will be performed according to the current standards, obtaining "clear" margins. The axillary lymph node control will depend on the initial management (clinical and ultrasound) of these N0 patients, chosen by the teams.
Intra Operative Radiotherapy (IORT):
After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeam™) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure.
tumorectomy: Tumorectomy will be performed according to the current standards, obtaining "clear" margins. The axillary lymph node control will depend on the initial management (clinical and ultrasound) of these N0 patients, chosen by the teams.
Intra Operative Radiotherapy: After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeam™) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure
|
|---|---|
|
Metastasis Relapse-free Survival
patient with a metastatic relapse
|
1 Participants
|
|
Metastasis Relapse-free Survival
patient without a metastatic relapse
|
52 Participants
|
SECONDARY outcome
Timeframe: from the baseline to 5 years after treatmentNumber of patient with and without a relapse
Outcome measures
| Measure |
Surgery and Intra Operative Radiotherapy
n=53 Participants
Surgery :
Tumorectomy will be performed according to the current standards, obtaining "clear" margins. The axillary lymph node control will depend on the initial management (clinical and ultrasound) of these N0 patients, chosen by the teams.
Intra Operative Radiotherapy (IORT):
After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeam™) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure.
tumorectomy: Tumorectomy will be performed according to the current standards, obtaining "clear" margins. The axillary lymph node control will depend on the initial management (clinical and ultrasound) of these N0 patients, chosen by the teams.
Intra Operative Radiotherapy: After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeam™) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure
|
|---|---|
|
Disease-free Survival.
patients with relapse
|
9 Participants
|
|
Disease-free Survival.
patients without relapse
|
44 Participants
|
SECONDARY outcome
Timeframe: from the baseline to 5 years after treatmentPopulation: only 53 patients analysable for this objective
number de patient dead
Outcome measures
| Measure |
Surgery and Intra Operative Radiotherapy
n=53 Participants
Surgery :
Tumorectomy will be performed according to the current standards, obtaining "clear" margins. The axillary lymph node control will depend on the initial management (clinical and ultrasound) of these N0 patients, chosen by the teams.
Intra Operative Radiotherapy (IORT):
After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeam™) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure.
tumorectomy: Tumorectomy will be performed according to the current standards, obtaining "clear" margins. The axillary lymph node control will depend on the initial management (clinical and ultrasound) of these N0 patients, chosen by the teams.
Intra Operative Radiotherapy: After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeam™) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure
|
|---|---|
|
Overall Survival
|
6 participants
|
SECONDARY outcome
Timeframe: from the baseline to 5 years after treatmentPopulation: number of patient with mastectomy
Number of patient with a mastectomy during the study and follow up
Outcome measures
| Measure |
Surgery and Intra Operative Radiotherapy
n=53 Participants
Surgery :
Tumorectomy will be performed according to the current standards, obtaining "clear" margins. The axillary lymph node control will depend on the initial management (clinical and ultrasound) of these N0 patients, chosen by the teams.
Intra Operative Radiotherapy (IORT):
After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeam™) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure.
tumorectomy: Tumorectomy will be performed according to the current standards, obtaining "clear" margins. The axillary lymph node control will depend on the initial management (clinical and ultrasound) of these N0 patients, chosen by the teams.
Intra Operative Radiotherapy: After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeam™) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure
|
|---|---|
|
Free Interval Without Mastectomy.
|
3 participants
|
Adverse Events
Surgery and Intra Operative Radiotherapy
Serious events: 3 serious events
Other events: 59 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Surgery and Intra Operative Radiotherapy
n=59 participants at risk
Surgery :
Tumorectomy will be performed according to the current standards, obtaining "clear" margins. The axillary lymph node control will depend on the initial management (clinical and ultrasound) of these N0 patients, chosen by the teams.
Intra Operative Radiotherapy (IORT):
After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeam™) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure.
tumorectomy: Tumorectomy will be performed according to the current standards, obtaining "clear" margins. The axillary lymph node control will depend on the initial management (clinical and ultrasound) of these N0 patients, chosen by the teams.
Intra Operative Radiotherapy: After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeam™) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure
|
|---|---|
|
Musculoskeletal and connective tissue disorders
lumbosacral radiculopathy
|
1.7%
1/59 • Number of events 1 • adverse event were collected from baseline to 5 years after the surgery
|
|
Infections and infestations
postoperative wound infection
|
1.7%
1/59 • Number of events 1 • adverse event were collected from baseline to 5 years after the surgery
|
|
Infections and infestations
mastitis
|
1.7%
1/59 • Number of events 1 • adverse event were collected from baseline to 5 years after the surgery
|
Other adverse events
| Measure |
Surgery and Intra Operative Radiotherapy
n=59 participants at risk
Surgery :
Tumorectomy will be performed according to the current standards, obtaining "clear" margins. The axillary lymph node control will depend on the initial management (clinical and ultrasound) of these N0 patients, chosen by the teams.
Intra Operative Radiotherapy (IORT):
After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeam™) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure.
tumorectomy: Tumorectomy will be performed according to the current standards, obtaining "clear" margins. The axillary lymph node control will depend on the initial management (clinical and ultrasound) of these N0 patients, chosen by the teams.
Intra Operative Radiotherapy: After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeam™) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure
|
|---|---|
|
Ear and labyrinth disorders
hearing and inner ear disorder
|
1.7%
1/59 • Number of events 1 • adverse event were collected from baseline to 5 years after the surgery
|
|
Eye disorders
visual system disorder
|
3.4%
2/59 • Number of events 2 • adverse event were collected from baseline to 5 years after the surgery
|
|
Gastrointestinal disorders
gastrointestinal disorders
|
6.8%
4/59 • Number of events 4 • adverse event were collected from baseline to 5 years after the surgery
|
|
General disorders
general disorders and reaction at the site of administration
|
27.1%
16/59 • Number of events 16 • adverse event were collected from baseline to 5 years after the surgery
|
|
Infections and infestations
Infections and infestations
|
5.1%
3/59 • Number of events 3 • adverse event were collected from baseline to 5 years after the surgery
|
|
Investigations
medical exams
|
5.1%
3/59 • Number of events 3 • adverse event were collected from baseline to 5 years after the surgery
|
|
Metabolism and nutrition disorders
metabolism and nutrition disorders
|
3.4%
2/59 • Number of events 2 • adverse event were collected from baseline to 5 years after the surgery
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal and connective tissue disorders
|
83.1%
49/59 • Number of events 49 • adverse event were collected from baseline to 5 years after the surgery
|
|
Nervous system disorders
nervous system disorder
|
3.4%
2/59 • Number of events 2 • adverse event were collected from baseline to 5 years after the surgery
|
|
Psychiatric disorders
psychiatric disorders
|
6.8%
4/59 • Number of events 4 • adverse event were collected from baseline to 5 years after the surgery
|
|
Renal and urinary disorders
renal and urinary disorders
|
1.7%
1/59 • Number of events 1 • adverse event were collected from baseline to 5 years after the surgery
|
|
Reproductive system and breast disorders
reproductive system and breast disorders
|
49.2%
29/59 • Number of events 29 • adverse event were collected from baseline to 5 years after the surgery
|
|
Respiratory, thoracic and mediastinal disorders
respiratory, thoracic and mediastinal disorders
|
1.7%
1/59 • Number of events 1 • adverse event were collected from baseline to 5 years after the surgery
|
|
Skin and subcutaneous tissue disorders
skin and subcutaneous tissue disorders
|
62.7%
37/59 • Number of events 37 • adverse event were collected from baseline to 5 years after the surgery
|
|
Surgical and medical procedures
surgical ann medical procedures
|
1.7%
1/59 • Number of events 1 • adverse event were collected from baseline to 5 years after the surgery
|
|
Vascular disorders
vascular disorders
|
42.4%
25/59 • Number of events 25 • adverse event were collected from baseline to 5 years after the surgery
|
Additional Information
Mme Aurore Moussion, Director of Direction of Clinical Research and Innovation
INSTITUT REGIONAL DU CANCER DE MONTPELLIER Cancer de Montpellier
Phone: 0467613102
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place