Clinical trial · Interventional
Trial of Radiation Fractionation Schedules for Once-a-Day Accelerated Partial Breast Irradiation
A Phase II Randomized Trial of Radiation Fractionation Schedules for Once-a-Day Accelerated Partial Breast Irradiation (OPAR)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| DCIS | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| APBI: 27.5 Gy | Radiation | — | UNRESOLVED |
| APBI: 30 Gy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- APBI: 30 Gy
- description
- Radiotherapy of 3 Dimensional Conformal Radiation Therapy (3DCRT) Accelerated Partial Breast Irradiation (APBI) 30 Gy in 5 daily fractions of 6 Gy
- interventionNames
- Radiation: APBI: 30 Gy
- type
- EXPERIMENTAL
- label
- APBI: 27.5 Gy
- description
- Radiotherapy of 3 Dimensional Conformal Radiation Therapy (3DCRT) Accelerated Partial Breast Irradiation (APBI) 27.5 Gy in 5 daily fractions of 5.5 Gy
- interventionNames
- Radiation: APBI: 27.5 Gy
Primary outcomes (1)
- measure
- Adverse cosmetic outcome using the EORTC Breast Cosmetic Rating System
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria:
1. Females with a new histological diagnosis of DCIS or invasive carcinoma of the breast with no evidence of metastatic disease.
2. Treated by BCS with microscopically clear resection margins for invasive and non-invasive disease (or no residual disease on re-excision).
3. 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.
Exclusion Criteria:
1. Age less than 50 years
2. Known to be Breast Cancer Type 1 Susceptibility Protein (BRCA 1) and/or Breast Cancer Type 2 Susceptibility Protein (BRCA 2) positive
3. Tumour size \>3 cm in greatest diameter on pathological examination (including the invasive and non-invasive components)
4. Tumour invades the skin (i.e. T4 disease)
5. Tumour histology limited to lobular carcinoma only
6. Grade III invasive breast carcinoma or nuclear grade III for patients with DCIS alone
7. Triple negative invasive breast cancer
8. Her2+ve invasive breast cancer that will not receive Herceptin
9. Bilateral invasive malignancy of the breast (synchronous or metachronous)
10. More than one primary tumor in different quadrants of the same breast
11. Presence of an ipsilateral breast implant or pacemaker
12. Status for adjuvant systemic therapy not determined
13. Unable to commence radiation therapy:
1. within 12 weeks of the last surgical procedure on the breast, or
2. within 8 weeks of the last dose of chemotherapy
14. Previous or concurrent malignancies except:
1. Non-melanoma skin cancer
2. Carcinoma in-situ of the cervix
3. Invasive carcinoma of the cervix, endometrium, colon and thyroid, treated 5 years prior to study entry with no evidence of disease
15. Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus erythematosus (SLE), scleroderma) which would preclude definitive radiation treatment.
16. Current pregnancy or lactating.
17. Psychiatric or addictive disorders which would preclude obtaining informed consent or adherence to the protocol.
18. Geographic inaccessibility for follow-up.
19. Inability to localize surgical cavity on CT (i.e. no evidence of surgical clips or seroma)
20. Inability to adequately plan the patient for the experimental technique.References
Publications (1)
- DERIVEDKim 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