Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00418210




Registration number
NCT00418210
Ethics application status
Date submitted
2/01/2007
Date registered
4/01/2007
Date last updated
5/12/2019

Titles & IDs
Public title
Accelerated Partial Breast Irradiation for Early Breast Cancer
Scientific title
A Multicentre Feasibility Study of Accelerated Partial Breast Irradiation Using Three-dimensional Conformal Radiation Therapy for Early Breast Cancer.
Secondary ID [1] 0 0
ACTRN12607000238471
Secondary ID [2] 0 0
TROG 06.02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Accelerated partial breast irradiation (APBI) to region of tumour bed using 3D conformal radiation therapy (3D CRT)

Experimental: Accelerated partial breast irradiation - Accelerated partial breast irradiation (APBI) to region of tumour bed using 3D conformal radiation therapy (3D CRT)


Treatment: Other: Accelerated partial breast irradiation (APBI) to region of tumour bed using 3D conformal radiation therapy (3D CRT)
Accelerated partial breast irradiation (APBI) to region of tumour bed using 3D conformal radiation therapy (3D CRT; 38.5 Gy in 3.85 Gy fractions bi-daily over 5 consecutive working days
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility rate of APBI using 3D conformal radiation therapy
Timepoint [1] 0 0
First analysis will occur 6 months after accrual of all patients (approximately 1.5 years after start of trial)
Secondary outcome [1] 0 0
Radiation toxicity
Timepoint [1] 0 0
First analysis will occur 6 months after accrual of all patients (approximately 1.5 years after start of trial). A final analysis will occur when all patients have been followed up for 5 years.
Secondary outcome [2] 0 0
Cosmetic outcome
Timepoint [2] 0 0
First analysis will occur 5 years after accrual of all patients (approximately 6 years after start of trial)
Secondary outcome [3] 0 0
Quality of life
Timepoint [3] 0 0
First analysis will occur 5 years after accrual of all patients (approximately 6 years after start of trial). A final analysis will occur when all patients have been followed up for 5 years.
Secondary outcome [4] 0 0
Time to ipsilateral breast recurrence
Timepoint [4] 0 0
First analysis will occur 5 years after accrual of all patients (approximately 6 years after start of trial). A final analysis will occur when all patients have been followed up for 5 years.
Secondary outcome [5] 0 0
Disease free survival
Timepoint [5] 0 0
First analysis will occur 5 years after accrual of all patients (approximately 6 years after start of trial). A final analysis will occur when all patients have been followed up for 5 years.
Secondary outcome [6] 0 0
Overall survival
Timepoint [6] 0 0
A final analysis will occur when all patients have been followed up for 5 years.

Eligibility
Key inclusion criteria
Patients must fulfill all of the following criteria for admission to study:

- Women aged >= 50 years.

- Histologically confirmed diagnosis of invasive breast carcinoma of non-lobular
histology.

- Bilateral mammograms performed within 6 months prior to registration.

- Treated with breast conserving surgery (primary excision or re-excision) with negative
radial resection margins of >= 2 mm* for both the invasive and if present, associated
intraductal tumour.

*Patients with superficial or deep resection margin of < 2 mm are eligible if surgery
has removed all of the intervening breast tissue from the subcutaneous tissue to the
pectoralis fascia.

- Unifocal tumour measuring = 20 mm in maximum microscopic dimension.

- Negative nodal status determined by sentinel node biopsy, axillary dissection, or for
women > 70 years of age, clinical examination.

- No evidence of distant metastasis.

- Assessed by surgeon and radiation oncologist to be suitable for breast conserving
therapy.

- Ability to tolerate protocol therapy.

- Protocol therapy must commence no later than 12 weeks from the last surgical procedure
or 8 weeks from the last dose of chemotherapy.

- Availability for long-term follow-up.

- Women of child-bearing potential must use adequate contraception during RT.

- Written informed consent.
Minimum age
50 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who fulfill any of the following criteria are not eligible for admission to study:

- Multifocal or multicentric tumours.

- Clinical or pathologic evidence of any of the following tumour features: extension to
chest wall (excluding pectoralis muscle); oedema (including peau d'orange) or
ulceration of skin; satellite skin nodules confined to the same breast; and
inflammatory carcinoma.

- Presence of extensive intraductal component (ductal carcinoma in situ occupying > 25%
of the primary invasive tumour and present adjacent to the primary tumour).

- Node-positive breast cancer determined by sentinel node biopsy, axillary dissection,
or in women > 70 years of age, clinical examination.

- Inability to localise surgical cavity on CT scans with no evidence of a surgical
cavity, seroma or surgical clips delineating the tumour bed.

- Treatment target volume estimated to occupy > 25% of the ipsilateral whole breast
volume.

- Synchronous or metachronous bilateral invasive or intraductal breast cancer.

- Locally recurrent breast cancer.

- Ipsilateral breast implant.

- Serious non-malignant disease that precludes definitive surgical or radiation
treatment (e.g. scleroderma, systemic lupus erythematosus,
cardiovascular/pulmonary/renal disease).

- Previous or concomitant malignancies except non-melanoma skin cancer, carcinoma in
situ of the cervix, and invasive carcinoma of the colon, thyroid, cervix, or
endometrium treated five years prior to study entry.

- Women who are pregnant or lactating.

- Psychiatric or addictive disorders that preclude obtaining informed consent or
adherence to protocol

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/08/2018
Sample size
Target
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Calvary Mater Newcastle - Newcastle
Recruitment hospital [2] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Wooloongabba
Recruitment hospital [4] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [5] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2298 - Newcastle
Recruitment postcode(s) [2] 0 0
2069 - Sydney
Recruitment postcode(s) [3] 0 0
4102 - Wooloongabba
Recruitment postcode(s) [4] 0 0
8006 - Melbourne
Recruitment postcode(s) [5] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Other
Name
Trans Tasman Radiation Oncology Group
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Peter MacCallum Cancer Centre, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Hypothesis:

In selected women with node-negative invasive breast cancer treated with breast conserving
surgery, postoperative accelerated partial breast irradiation (APBI) limited to the region of
the tumour bed delivered by 3-dimensional conformal radiation therapy (3D CRT) is technically
feasible and reproducible with acceptable treatment toxicity, cosmetic outcome, and local
control rate in a multicentre trial.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00418210
Trial related presentations / publications
Kron T, Willis D, Miller J, Hubbard P, Oliver M, Chua B. A spreadsheet to determine the volume ratio for target and breast in partial breast irradiation. Australas Phys Eng Sci Med. 2009 Jun;32(2):98-104. doi: 10.1007/BF03178635.
Public notes

Contacts
Principal investigator
Name 0 0
Boon Chua
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00418210