Clinical trial NCT05417516: A Randomized Trial of Five Fraction Partial Breast Irradiation (RAPID2)
Official title: A Randomized Trial of Five-Fraction Partial Breast Irradiation (RAPID2)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Breast Neoplasm Female
Radiotherapy
Cosmetic Outcome
Lead sponsor: Ontario Clinical Oncology Group (OCOG)
Sponsor class: OTHER
Collaborators: name: GenesisCare AU
First posted: 2022-06-14
Enrollment: 910
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine in women with node negative BC ≤3cm in size, if PBI compared to WBI, both given once-a-day over 1 week following BCS, is non-inferior for LR and reduces adverse cosmesis. The primary outcomes are LR and patient-assessed cosmesis at 3 years post randomization.

Detailed description: This is a randomized, two-arm, single blinded trial comparing two radiation treatment modalities, PBI and WBI. Following BCS or on the completion of additional adjuvant chemotherapy, eligible and consenting patients with newly diagnosed and histologically confirmed invasive carcinoma of the breast (without evidence of metastatic disease); with microscopically clear resection margins of 1mm (or no residual disease on re-excision) and negative axillary node involvement will be randomized in a 1:1 fashion to receive either PBI (experimental group) or WBI (control group). Study participants will receive 26Gy in 5 fractions in both treatment arms, treated once per day, for a period of 5-7 days. Study participants will not be made aware of treatment allocation to prevent any potential bias in their assessment of cosmesis. Stratification factors include tumour size, estrogen receptor (ER) status, and clinical centre.

Eligibility criteria: Inclusion Criteria:

For inclusion in this study, patients must fulfill all of the following criteria:

1. Female with a new histological diagnosis of invasive carcinoma of the breast with no evidence of metastatic disease (see AJCC TNM Cancer Staging, Appendix II).
2. Treated by BCS with microscopically clear resection margins \>= 1mm for invasive and non-invasive disease or no residual disease on re-excision.
3. Negative axillary node involvement as determined by either sentinel lymph node biopsy or axillary node dissection or clinical assessment with a negative axillary ultrasound and/or biopsy, for women with unifocal tumours \<= 2cm, histologic grade 1 or 2, ER or PR+ and HER2-ve that are being planned for endocrine therapy

Exclusion Criteria:

Patients who satisfy any of the following exclusion criteria are NOT eligible for this study:

1. Age less than 50 years.
2. Known to be BRCA 1 and/or BRCA 2 positive.
3. Tumour size \>3cm in greatest diameter on pathological examination.
4. Evidence of extensive intraductal component (EIC) (defined as an invasive tumour with a ductal carcinoma in situ (DCIS) component comprising at least 25% and extending beyond the invasive component to surrounding normal breast tissue) with the following exception: smaller tumours with EIC where the combined size (of the invasive and DCIS components) are \<= 3cm remain eligible
5. Evidence of a DCIS component \> 3cm
6. Lobular carcinoma only.
7. More than one primary tumour in different quadrants of the same breast (patients with multifocal breast cancer are eligible).
8. Synchronous or previous contralateral breast cancer (patients with contralateral DCIS or LCIS are eligible).
9. History of non-breast malignancy within the last 5 years other than treated non-melanoma skin cancer or treated in-situ carcinoma.
10. Known pregnancy or currently lactating.
11. Inability to localize tumour bed on CT planning (no evidence of surgical clips or seroma).
12. Inability to plan the patient for the experimental technique.

Primary outcomes:
measure: Local Recurrence
timeFrame: Annually for 5 years post-randomization
measure: Patient Assessment Cosmesis at 3 years
timeFrame: 3 and 5 years post-randomization
Secondary outcomes:
measure: Distant Disease Free Survival (DDSF)
timeFrame: Annually for 5 years post-randomization.
measure: Disease Free Survival (DFS)
timeFrame: Annually for 5 years post-randomization.
measure: Overall Survival
timeFrame: 3 years post-randomizaton.
measure: Radiation Toxicity
timeFrame: 2 weeks and 3 months post-radiation treatment, then annually for 5 years post-randomization.
measure: Nurse/Clinical Research Associate assessed cosmesis at 3 and 5 years.
timeFrame: 3 and 5 years post-randomization.
measure: Patient Assessed Cosmesis at 5 years.
timeFrame: 5 years post-randomization.
measure: Patient Reported Quality of Life
timeFrame: 2 weeks post-radiation treatment, then at 3 and 5 years post-randomization.
Other outcomes:
Locations:
city: Hurstville
country: Australia
facility: GenesisCare Hurstville
state: New South Wales
city: North Sydney
country: Australia
facility: GenesisCare Mater Hospital
state: New South Wales
city: Bundaberg
country: Australia
facility: GenesisCare Bundaberg
state: Queensland
city: Southport
country: Australia
facility: GenesisCare Southport
state: Queensland
city: Tugun
country: Australia
facility: GenesisCare Tugun
state: Queensland
city: Adelaide
country: Australia
facility: GenesisCare St Andrew's
state: South Australia
city: Murdoch
country: Australia
facility: GenesisCare Fiona Stanley Hospital
state: Western Austrailia
city: Nedlands
country: Australia
facility: GenesisCare Hollywood
state: Western Australia
city: Calgary
country: Canada
facility: Arthur J. E. Child Comprehensive Cancer Centre-Clinical Research Unit
state: Alberta
city: Victoria
country: Canada
facility: BCCA-Vancouver Island Cancer Centre
state: British Columbia
city: Halifax
country: Canada
facility: QEII HSC - Nova Scotia Cancer Centre
state: Nova Scotia
city: Barrie
country: Canada
facility: Royal Victoria Regional Health Centre
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Centre
state: Ontario
city: Newmarket
country: Canada
facility: Stronach (Southlake) Regional Health Centre
state: Ontario
city: Sault-Sainte-Marie
country: Canada
facility: Algoma District Cancer Program
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto-Sunnybrook Health Sciences Centre - Odette Cancer Centre
state: Ontario
city: Windsor
country: Canada
facility: Windsor Regional Cancer Centre
state: Ontario
city: Greenfield Park
country: Canada
facility: CSSS Champlain - Charles LeMoyne
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Québec
country: Canada
facility: CHUQ-Pavillon Hotel-Dieu de Quebec
state: Quebec
city: Trois-Rivières
country: Canada
facility: Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie-Centre-du-Québec (CIUSSS MCQ)
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre
state: Saskatchewan
Study officials:
affiliation: Juravinski Cancer Centre and McMaster University
name: Timothy Whelan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: