A Randomized Trial of Five Fraction Partial Breast Irradiation

Radiotherapy Clinical Trial

Official title:

A Randomized Trial of Five-Fraction Partial Breast Irradiation (RAPID2)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05417516
• Other study ID #: OCOG-2022-RAPID2
• Status: Recruiting
• Phase: Phase 3
• Start date: November 20, 2023
• Est. completion date: November 2031

Study information

• Verified date: October 2023
• Source: Ontario Clinical Oncology Group (OCOG)
• Contact: Shelley Chambers, MA
• Phone: 905-928-8842
• Email: chamberss[@]hhsc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 910
• Est. completion date: November 2031
• Est. primary completion date: November 2029
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 120 Years

Eligibility

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.(AJCC TNM Cancer Staging).

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.

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. Lobular carcinoma only.

5. More than one primary tumour in different quadrants of the same breast (patients with multifocal breast cancer are eligible).

6. Synchronous or previous contralateral breast cancer (patients with contralateral DCIS or LCIS are eligible).

7. History of non-breast malignancy within the last 5 years other than treated non-melanoma skin cancer or treated in-situ carcinoma.

8. Known pregnancy or currently lactating.

9. Inability to localize tumour bed on CT planning (no evidence of surgical clips or seroma).

10. Inability to plan the patient for the experimental technique.

Related Conditions & MeSH terms

• Breast Neoplasm Female
• Breast Neoplasms
• Cosmetic Outcome
• Radiotherapy

Intervention

Radiation:
• Whole Breast Irradiation (WBI)
The dose fractionation and prescription is 26Gy in 5 fractions to the PTV once per day over 5-7 days (due to holiday weekends up to 8 days will be acceptable).
• Partial Breast Irradiation (PBI)
The dose fractionation and prescription is 26Gy in 5 fractions to the PTV prescribed at the isocentre of the treatment fields treated once per day over 5-7 days (due to holiday weekends up to 8 days will be acceptable).

Locations

Country	Name	City	State
Canada	Royal Victoria Regional Health Centre	Barrie	Ontario
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	CIUSS du Saguenay-Lac-Saint-Jean	Chicoutimi	Quebec
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	CSSS Champlain - Charles LeMoyne	Greenfield Park	Quebec
Canada	QEII HSC - Nova Scotia Cancer Centre	Halifax	Nova Scotia
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	Hopital de la Cite-de-la-Sante	Laval	Quebec
Canada	Lethbridge Cancer Centre	Lethbridge	British Columbia
Canada	Centre integre de cancerologie de Chaudieres Appalaches	Lévis	Quebec
Canada	London Regional Cancer Centre	London	Ontario
Canada	London Regional Cancer Program	London	Ontario
Canada	The Vitalite Health Network - Dr. Leon Richard Oncology Centre	Moncton	Nova Scotia
Canada	McGill University Health Centre	Montréal	Quebec
Canada	Stronach (Southlake) Regional Health Centre	Newmarket	Ontario
Canada	BCCA-Centre for the North	Prince George	British Columbia
Canada	CHUQ-Pavillon Hotel-Dieu de Quebec	Québec	Quebec
Canada	Allan Blair Cancer Centre	Regina	Saskatchewan
Canada	Dr. H. Bliss Murphy Cancer Centre	Saint John's	NFLD
Canada	Saskatoon Cancer Centre	Saskatoon	Saskatchewan
Canada	Algoma District Cancer Program	Sault-Sainte-Marie	Ontario
Canada	Thunder Bay Regional Health Sciences	Thunder Bay	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	Toronto-Sunnybrook Regional Cancer Centre	Toronto	Ontario
Canada	Centre Hospitalier Regional de Trois-Rivieres	Trois-Rivières	Quebec
Canada	BCCA-Vancouver Island Cancer Centre	Victoria	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Ontario Clinical Oncology Group (OCOG)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Recurrence	Time from randomization to any evidence of tumour recurrence (invasive and non-invasive) in the treated breast.	Annually for 5 years post-randomization
Primary	Patient Assessment Cosmesis at 3 years	Cosmesis will be assessed by the patient using the Breast Cosmesis Questionnaire which incorporates the Modified EORTC Breast Cosmetic Rating System and the UK Patient Reported Outcomes Questions following BCS.	3 and 5 years post-randomization
Secondary	Distant Disease Free Survival (DDSF)	Time from randomization to evidence of metastasis involving distant sites (e.g. bone, liver, lung, or brain).	Annually for 5 years post-randomization.
Secondary	Disease Free Survival (DFS)	Time from randomization to local recurrence, regional or distant recurrence, contralateral breast cancer, other second cancer, or death.	Annually for 5 years post-randomization.
Secondary	Overall Survival	Time from randomization to death of any cause.	3 years post-randomizaton.
Secondary	Radiation Toxicity	Acute (2 weeks and up to 3 months after completing RT) and late toxicity (beyond the 3 months after completing RT) will be assessed by clinical centre personnel using the NCI CTCAE version 5.0.	2 weeks and 3 months post-radiation treatment, then annually for 5 years post-randomization.
Secondary	Nurse/Clinical Research Associate assessed cosmesis at 3 and 5 years.	A nurse/Clinical Research Associate (CRA) assessment of cosmesis using the EORTC Breast Cosmetic Rating System. Nurses and CRAs will be training in assessing cosmesis using training slides and guide previously developed for other trials.	3 and 5 years post-randomization.
Secondary	Patient Assessed Cosmesis at 5 years.	Cosmesis will be assessed by the patient using the Breast Cosmesis Questionnaire which incorporates the Modified EORTC Breast Cosmetic Rating System13,27,42 and the UK Patient Reported Outcomes Questions following BCS.	5 years post-randomization.
Secondary	Patient Reported Quality of Life	Patients will complete the EORTC Breast Cancer Quality of life questionnaire	2 weeks post-radiation treatment, then at 3 and 5 years post-randomization.