Trial of Radiation Fractionation Schedules for Once-a-Day Accelerated Partial Breast Irradiation

NCT02637024 | Completed Phase 2 DMC

• 1 other identifier: OCOG-2015-OPAR
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 10

Brief Summary

This is a multi-centre randomized phase II trial in women with invasive carcinoma of the breast with negative axillary nodes or Ductal Carcinoma In-situ (DCIS) treated by Breast Conserving Surgery (BCS). Eligible, consenting patients will be randomly allocated to receive radiotherapy of 3 Dimensional Conformal Radiation Therapy (3DCRT) Accelerated Partial Breast Irradiation (APBI) 30 Gray (Gy) in 5 daily fractions of 6Gy or 27.5Gy in 5 daily fractions of 5.5Gy over one week. Patients will be followed at 12, 24, 36 and 60 months post randomization. Cosmetic outcome will be measured using photographs and evaluated by a panel of trained radiation oncologists. Radiation toxicity will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).

Conditions

Breast Cancer; DCIS

Keywords

Breast Cancer; DCIS; Radiotherapy; Partial breast irradiation; Radiation fractions

Outcome Measures

Primary Outcomes (1)

• Adverse cosmetic outcome using the EORTC Breast Cosmetic Rating System

  The primary outcome is adverse cosmesis assessed at 2 years post randomization as determined by photographic assessment. The cosmetic outcome will be assessed by a panel of 3 trained radiation oncologists who are unaware of treatment allocation, using the EORTC Breast Cosmetic Rating System for cosmetic results for breast conserving treatment. The treated breast is compared with the untreated breast for size, shape, location of the areola/nipple, appearance of the surgical scar, presence of telangiectasia, and a global cosmetic score based on these factors. Characteristics are graded on a 4-point scale: 0 = excellent; 1 = good; 2 = fair; 3 = poor. A global cosmetic score of fair or poor will be used as the primary outcome of adverse cosmesis.

  2 years post randomization

Secondary Outcomes (5)

• Cosmetic deterioration (defined as any adverse change in the global cosmetic score)

  Baseline to two years

• Radiation toxicity assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.4.02

  12, 24, 36 and 60 months

• Ipsilateral breast tumour recurrence (IBTR)

  Ongoing throughout study up to 5 years

• Disease free survival (DFS)

  Ongoing throughout study up to 5 years

• Overall survival (OS)

  From date of randomization until the date of death up to 5 years

Study Arms (2)

APBI: 30 Gy

EXPERIMENTAL

Radiotherapy of 3 Dimensional Conformal Radiation Therapy (3DCRT) Accelerated Partial Breast Irradiation (APBI) 30 Gy in 5 daily fractions of 6 Gy

Radiation: APBI: 30 Gy

APBI: 27.5 Gy

EXPERIMENTAL

Radiotherapy of 3 Dimensional Conformal Radiation Therapy (3DCRT) Accelerated Partial Breast Irradiation (APBI) 27.5 Gy in 5 daily fractions of 5.5 Gy

Radiation: APBI: 27.5 Gy

Interventions

APBI: 30 Gy RADIATION

30 Gy in 5 fractions of 6 Gy, delivered daily, Monday to Friday, over a period of 5-8 days. A multiple small field 3D-conformal or intensity modulated radiation therapy (IMRT) technique will be used.

APBI: 30 Gy

APBI: 27.5 Gy RADIATION

27.5 Gy in 5 fractions of 5.5 Gy, delivered daily, Monday to Friday, over a period of 5-8 days. A multiple small field 3D-conformal or intensity modulated radiation therapy (IMRT) technique will be used.

APBI: 27.5 Gy

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females with a new histological diagnosis of DCIS or invasive carcinoma of the breast with no evidence of metastatic disease.
• Treated by BCS with microscopically clear resection margins for invasive and non-invasive disease (or no residual disease on re-excision).
• Negative axillary node involvement, including positive cells only identified by Immunohistochemistry (IHC) as determined either by sentinel node biopsy or axillary node dissection, or a clinical exam for patients with DCIS only.

You may not qualify if:

• Age less than 50 years
• Known to be Breast Cancer Type 1 Susceptibility Protein (BRCA 1) and/or Breast Cancer Type 2 Susceptibility Protein (BRCA 2) positive
• Tumour size \>3 cm in greatest diameter on pathological examination (including the invasive and non-invasive components)
• Tumour invades the skin (i.e. T4 disease)
• Tumour histology limited to lobular carcinoma only
• Grade III invasive breast carcinoma or nuclear grade III for patients with DCIS alone
• Triple negative invasive breast cancer
• Her2+ve invasive breast cancer that will not receive Herceptin
• Bilateral invasive malignancy of the breast (synchronous or metachronous)
• More than one primary tumor in different quadrants of the same breast
• Presence of an ipsilateral breast implant or pacemaker
• Status for adjuvant systemic therapy not determined
• Unable to commence radiation therapy:
• within 12 weeks of the last surgical procedure on the breast, or
• within 8 weeks of the last dose of chemotherapy

Sponsors & Collaborators

• Ontario Clinical Oncology Group (OCOG): lead
• Canadian Breast Cancer Foundation: collaborator

Study Sites (10)

Simcoe Muskoka Regional Cancer Centre, Royal Victoria Hospital

Barrie, Ontario, L4M 6M2, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, L8V5C2, Canada

Location

Grand River Regional Cancer Centre

Kitchener, Ontario, N2G 1G3, Canada

Location

London Regional Cancer Program; London Health Sciences Centre

London, Ontario, N6A4L6, Canada

Location

Odette Cancer Centre, Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Windsor Regional Cancer Centre

Windsor, Ontario, N8W 2X3, Canada

Location

Hopital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

CHUM Centre Hospitalier de L'Université de Montréal

Montreal, Quebec, H2L 4M1, Canada

Location

CHUQ Pavillon Hotel-Dieu Quebec

Québec, Quebec, G1R 2J6, Canada

Location

CHUS - Hopital Fleurimont

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (1)

• Kim DH, Theberge V, Parpia S, Kong I, Provencher S, Yassa M, Perera F, Lavertu S, Rousseau P, Lee J, Karam I, Schneider K, Levine MN, Whelan TJ; OPAR Study Investigators. OPAR: A Randomized Trial of Partial Breast Irradiation in Five Fractions Once Daily for Early Breast Cancer. J Clin Oncol. 2025 Feb 10;43(5):505-512. doi: 10.1200/JCO.24.00600. Epub 2024 Oct 8.

  PMID: 39378393 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Study Officials

• Do-Hoon Kim, MD

  Juravinski Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: December 22, 2015
• Study Start: May 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (10)