Trial Outcomes & Findings for Post-operative Radiation With IMRT in the Management of Stage IIB-III Breast Cancer (NCT NCT00508352)

NCT ID: NCT00508352

Last Updated: 2025-06-13

Results Overview

Grade 3 or higher radiation effects(less than 90 days post treatment)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: less than 90 days post treatment
• Results posted on: 2025-06-13

Participant Flow

Participant milestones

Measure	Helical Tomotherapy Helical tomotherapy IMRT: Helical tomotherapy IMRT 50 Gy in 25 fractions, daily treatment
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Helical Tomotherapy n=30 Participants Helical tomotherapy IMRT: Helical tomotherapy IMRT 50 Gy in 25 fractions, daily treatment
Age, Continuous	52 Years n=30 Participants
Sex: Female, Male Female	30 Participants n=30 Participants
Sex: Female, Male Male	0 Participants n=30 Participants
Region of Enrollment Canada	30 participants n=30 Participants

PRIMARY outcome

Timeframe: less than 90 days post treatment

Grade 3 or higher radiation effects(less than 90 days post treatment)

Outcome measures

Measure	Helical Tomotherapy n=30 Participants Helical tomotherapy IMRT: Helical tomotherapy IMRT 50 Gy in 25 fractions, daily treatment
Acute Radiation Effects (Less Than 90 Days Post Treatment)	0 Participants

PRIMARY outcome

Timeframe: up to 1 year post radiation

Grade 3 or higher moderate-late pulmonary and cardiac radiation effects up to 1 year post radiation

Outcome measures

Measure	Helical Tomotherapy n=30 Participants Helical tomotherapy IMRT: Helical tomotherapy IMRT 50 Gy in 25 fractions, daily treatment
Moderate-late Pulmonary and Cardiac Radiation Effects	0 Participants

SECONDARY outcome

Timeframe: 5 years

Evaluate rate of local recurrence at 5 years

Outcome measures

Measure	Helical Tomotherapy n=30 Participants Helical tomotherapy IMRT: Helical tomotherapy IMRT 50 Gy in 25 fractions, daily treatment
Rate of Local Recurrence	0 Participants

SECONDARY outcome

Timeframe: 5 years

Evaluate rate of regional recurrence at 5 years

Outcome measures

Measure	Helical Tomotherapy n=30 Participants Helical tomotherapy IMRT: Helical tomotherapy IMRT 50 Gy in 25 fractions, daily treatment
Rate of Regional Recurrence	0 Participants

Adverse Events

Helical Tomotherapy

Serious events: 5 serious events

Other events: 0 other events

Deaths: 6 deaths

Serious adverse events

Measure	Helical Tomotherapy n=30 participants at risk Helical tomotherapy IMRT: Helical tomotherapy IMRT 50 Gy in 25 fractions, daily treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Distant Recurrent Disease	16.7% 5/30

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jean-Michel Caudrelier

Ottawa Hospital Research Institute

Phone: 613-737-8899

Email: jcaudrelier@toh.ca

Results disclosure agreements

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