A Randomized Trial of Five Fraction Partial Breast Irradiation

• Sponsor: Ontario Clinical Oncology Group (OCOG) (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05417516
• Collaborator: (none)
• Enrollment: 910
• Locations: 35
• Arms: 2
• Anticipated Duration (Months): 108
• Patients Per Site: 26
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasm Female; Radiotherapy; Cosmetic Outcome	Radiation: Whole Breast Irradiation (WBI); Radiation: Partial Breast Irradiation (PBI)	Phase 3

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 910 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Masking Description: Study participants will be made unaware of treatment allocation to prevent any potential bias in their assessment of cosmesis.
• Primary Purpose: Treatment
• Official Title: A Randomized Trial of Five-Fraction Partial Breast Irradiation (RAPID2)
• Anticipated Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Jul 1, 2029
• Anticipated Study Completion Date: Jul 1, 2031

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Whole Breast Irradiation (WBI) 26 Gy in 5 fractions to the whole breast	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).
Experimental: Partial Breast Irradiation (PBI) 26 Gy in 5 fractions to the tumour bed with a margin of normal tissue	Radiation: 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).

Outcome Measures

Primary Outcome Measures

1. Local Recurrence [Annually for 5 years post-randomization]

   Time from randomization to any evidence of tumour recurrence (invasive and non-invasive) in the treated breast.

2. Patient Assessment Cosmesis at 3 years [3 and 5 years post-randomization]

   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.

Secondary Outcome Measures

1. Distant Disease Free Survival (DDSF) [Annually for 5 years post-randomization.]

   Time from randomization to evidence of metastasis involving distant sites (e.g. bone, liver, lung, or brain).

2. Disease Free Survival (DFS) [Annually for 5 years post-randomization.]

   Time from randomization to local recurrence, regional or distant recurrence, contralateral breast cancer, other second cancer, or death.

3. Overall Survival [3 years post-randomizaton.]

   Time from randomization to death of any cause.

4. Radiation Toxicity [2 weeks and 3 months post-radiation treatment, then annually for 5 years post-randomization.]

   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.

5. Nurse/Clinical Research Associate assessed cosmesis at 3 and 5 years. [3 and 5 years post-randomization.]

   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.

6. Patient Assessed Cosmesis at 5 years. [5 years post-randomization.]

   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.

7. Patient Reported Quality of Life [2 weeks post-radiation treatment, then at 3 and 5 years post-randomization.]

   Patients will complete the EORTC Breast Cancer Quality of life questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 120 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tom Baker Cancer Centre	Calgary	Alberta	Canada
2	Cross Cancer Institute	Edmonton	Alberta	Canada
3	Grand Prairie Cancer Centre	Grande Prairie	Alberta	Canada
4	Lethbridge Cancer Centre	Lethbridge	British Columbia	Canada
5	BCCA-Centre for the North	Prince George	British Columbia	Canada
6	BCCA-Vancouver Island Cancer Centre	Victoria	British Columbia	Canada
7	Regional Health Authority B, Zone 2 Saint John Regional Hospital	Saint John	New Brunswick	Canada
8	Dr. H. Bliss Murphy Cancer Centre	Saint John's	NFLD	Canada
9	QEII Health Sciences Centre Capital District Health Authority	Halifax	Nova Scotia	Canada
10	The Vitalite Health Network - Dr. Leon Richard Oncology Centre	Moncton	Nova Scotia	Canada
11	Royal Victoria Hospital	Barrie	Ontario	Canada
12	Grand River Regional Cancer Centre	Grand River	Ontario	Canada
13	Juravinski Cancer Centre	Hamilton	Ontario	Canada
14	Kingston Health Sciences Centre	Kingston	Ontario	Canada
15	London Regional Cancer Centre	London	Ontario	Canada
16	Carlo Fidani Peel Regional Cancer Centre	Mississauga	Ontario	Canada
17	Stronach (Southlake) Regional Health Centre	Newmarket	Ontario	Canada
18	Niagara Health System	St. Catharines	Ontario	Canada
19	Health Sciences North	Sudbury	Ontario	Canada
20	Thunder Bay Regional Health Sciences	Thunder Bay	Ontario	Canada
21	Princess Margaret Hospital	Toronto	Ontario	Canada
22	Toronto-Sunnybrook Regional Cancer Centre	Toronto	Ontario	Canada
23	Windsor Regional Cancer Centre	Windsor	Ontario	Canada
24	PEI Cancer Treatment Centre Queen Elizabeth Hospital	Charlottetown	PEI	Canada
25	CIUSS du Saguenay-Lac-Saint-Jean	Chicoutimi	Quebec	Canada
26	CSSS Champlain - Charles LeMoyne	Greenfield Park	Quebec	Canada
27	Hopital de la Cite-de-la-Sante	Laval	Quebec	Canada
28	Centre integre de cancerologie de Chaudieres Appalaches	Lévis	Quebec	Canada
29	CHUM-Hopital Notre-Dame	Montréal	Quebec	Canada
30	The Jewish General Hospital	Montréal	Quebec	Canada
31	The Research Institute of the McGill University Centre	Montréal	Quebec	Canada
32	CHUQ-Pavillon Hotel-Dieu de Quebec	Québec	Quebec	Canada
33	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec	Canada
34	Allan Blair Cancer Centre	Regina	Saskatchewan	Canada
35	Saskatoon Cancer Centre	Saskatoon	Saskatchewan	Canada

Sponsors and Collaborators

• Ontario Clinical Oncology Group (OCOG)

Investigators

• Principal Investigator: Timothy Whelan, M.D., Juravinski Cancer Centre and McMaster University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ontario Clinical Oncology Group (OCOG)
• ClinicalTrials.gov Identifier: NCT05417516
• Other Study ID Numbers: OCOG-2022-RAPID2
• First Posted: Jun 14, 2022
• Last Update Posted: Jun 14, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Jun 14, 2022