Trial Outcomes & Findings for Single Fraction Elderly Breast Irradiation (SiFEBI) (NCT NCT01727011)

NCT ID: NCT01727011

Last Updated: 2021-12-17

Results Overview

Rate of acute toxicity evaluated by a clinical examination, in consultation with the radiotherapist to 30, 90 days and 180 days. Common Toxicity Criteria classification for Adverse Events (CTCAE) in its fourth version is used.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 37 participants
• Primary outcome timeframe: 180 days
• Results posted on: 2021-12-17

Participant Flow

Participant milestones

Measure	Irradiation and Accelerated Partial Breast (IPAS) Once the patient recorded in the trial, and after completion of a post-implant dosimetry scanner to analyze the dose distribution within the target volume and organs at risk, the patient is treated by irradiation and partial accelerated breast brachytherapy using high dose rate, delivering a total dose of 16 Gy in one fraction IPAS
Overall Study STARTED	31
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Single Fraction Elderly Breast Irradiation (SiFEBI)

Baseline characteristics by cohort

Measure	IPAS n=37 Participants Once the patient recorded in the trial, and after completion of a post-implant dosimetry scanner to analyze the dose distribution within the target volume and organs at risk, the patient is treated by irradiation and partial accelerated breast brachytherapy using high dose rate, delivering a total dose of 16 Gy in one fraction IPAS
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	37 Participants n=5 Participants
Age, Continuous	76.6 years STANDARD_DEVIATION 5.6 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment France	37 participants n=5 Participants

PRIMARY outcome

Timeframe: 180 days

Rate of acute toxicity evaluated by a clinical examination, in consultation with the radiotherapist to 30, 90 days and 180 days.

Common Toxicity Criteria classification for Adverse Events (CTCAE) in its fourth version is used.

Outcome measures

Measure	IPAS n=26 Participants Once the patient recorded in the trial, and after completion of a post-implant dosimetry scanner to analyze the dose distribution within the target volume and organs at risk, the patient is treated by irradiation and partial accelerated breast brachytherapy using high dose rate, delivering a total dose of 16 Gy in one fraction IPAS
Rate of Acute Toxicity Within 180 Days of IPAS Mono Split Postoperatively in Patients Aged at Least of 70 Years With Breast Cancer at Low Risk of Local Recurrence (Low Risk Group of ESTRO IPAS Classification ESTRO)	70 percentage of participants

SECONDARY outcome

Timeframe: 180 days

Analysis of the impact on self assessment by onco-geriatric aesthetic result evaluation Dosimetric data analysis in order to propose dose constraints for future inverse planning

Outcome measures

Outcome data not reported

Adverse Events

IPAS

Serious events: 3 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Measure	IPAS n=26 participants at risk Once the patient recorded in the trial, and after completion of a post-implant dosimetry scanner to analyze the dose distribution within the target volume and organs at risk, the patient is treated by irradiation and partial accelerated breast brachytherapy using high dose rate, delivering a total dose of 16 Gy in one fraction IPAS
Reproductive system and breast disorders left breast painful inflammatory syndroma	3.8% 1/26 • Number of events 1
Cardiac disorders tacchycardia	3.8% 1/26 • Number of events 1
Reproductive system and breast disorders right breast haematoma	3.8% 1/26 • Number of events 1

Other adverse events

Measure	IPAS n=26 participants at risk Once the patient recorded in the trial, and after completion of a post-implant dosimetry scanner to analyze the dose distribution within the target volume and organs at risk, the patient is treated by irradiation and partial accelerated breast brachytherapy using high dose rate, delivering a total dose of 16 Gy in one fraction IPAS
Reproductive system and breast disorders BREAST FIBROSIS	53.8% 14/26 • Number of events 14
Skin and subcutaneous tissue disorders INJECTION SITE INFLAMMATION	7.7% 2/26 • Number of events 2
Reproductive system and breast disorders BREAST HAEMATOMA	15.4% 4/26 • Number of events 4
Reproductive system and breast disorders BREAST PAIN	7.7% 2/26 • Number of events 2
Skin and subcutaneous tissue disorders SKIN HYPERPIGMENTATION	19.2% 5/26 • Number of events 5
Skin and subcutaneous tissue disorders RADIATION SKIN INJURY	7.7% 2/26 • Number of events 2

Additional Information

Professeur JM Hannoun-Levi

Centre Antoine Lacassagne

Phone: 04.92.03.12.60

Email: jean-michel.hannoun-levi@nice.unicancer.fr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place