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Hypofractionated Partial Breast Irradiation in Treating Patients With Early Stage Breast Cancer
Optimizing Preventative Adjuvant Linac-Based Radiation: The OPAL Trial a Phase II/III Study of Hypofractionated Partial Breast Irradiation in Women With Early Stage Breast Cancer
2 other identifiers
interventional
928
1 country
15
Brief Summary
This phase II trial studies how well hypofractionated partial breast irradiation works in treating patients with early stage breast cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Treating only the part of the breast where the cancer started may lead to fewer side effects than standard treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2017
Longer than P75 for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2017
CompletedStudy Start
First participant enrolled
March 6, 2017
CompletedFirst Posted
Study publicly available on registry
March 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 8, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 8, 2027
March 5, 2026
March 1, 2026
10.7 years
March 6, 2017
March 3, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Risk of grade 2 or higher toxicity
Will evaluate whether or not the risk of this outcome is higher than the risk of grade 2+ toxic events in the best performing arm of our prior clinical trial that evaluated dosing schedules of whole breast irradiation (2010-0559).
At 6 months post radiation
Secondary Outcomes (9)
Patient-reported cosmetic outcome
At 6 months, one year, two years, three years, four years, and five years after completing the optimizing preventative adjuvant linac-based radiation (OPAL) regimen
Physician-reported and photographically-assessed cosmetic outcome
At 6 months, one year, two years, three years, four years, and five years after completing the OPAL regimen
Risk of pathologically-confirmed invasive and/or ipsilateral breast tumor recurrence (IBTR)
At 5 years
Risk of any recurrence of breast cancer
At 5 years
Disease free survival (DFS)
At 5 years
- +4 more secondary outcomes
Study Arms (2)
Arm I (hypofractionated partial breast irradiation)
EXPERIMENTALPatients undergo hypofractionated partial breast irradiation daily for 5 days. Patients may then receive 3 additional boost fractions at the discretion of the doctor.
Arm II (hypofractionated partial breast irradiation)
ACTIVE COMPARATORPatients undergo standard breast irradiation daily for 15 days. Patients may then receive 5 additional boost fractions at the discretion of the doctor.
Interventions
Correlative studies
Undergo hypofractionated partial breast irradiation
Ancillary studies
Eligibility Criteria
You may qualify if:
- Diagnosis of pathologically-confirmed invasive breast cancer or ductal carcinoma in situ
- Pathologic T stage of Tis, T1, or T2 with total size of tumor =\< 3 cm (this size criteria applies to both pure DCIS and invasive tumors)
- For patients with invasive breast cancer, pathologic N stage of N0, N0 (i-), or N0 (i+); pathologic staging of the axilla is not required for patients with pure DCIS
- Treatment with breast conserving surgery
- Unifocal primary tumor based on imaging and clinical assessment; microscopic multifocality is allowed
- Final surgical margins negative defined as no tumor on ink; lobular carcinoma in situ involving the final surgical margin will be disregarded
- For invasive cancers, the tumor must be estrogen receptor positive (defined as 10% or greater expression of estrogen receptor)
- If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed at least one month prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer
- Patients must be enrolled on the trial within 12 weeks of the later of two dates: the final breast conserving surgical procedure or administration of the last cycle of cytotoxic chemotherapy
- Final criteria for eligibility established after simulation: The tumor bed can be readily visualized on simulation computed tomography (CT) and is localized to one quadrant or region of the breast that is amenable to partial breast irradiation
You may not qualify if:
- Tumor invasion of the skin including dermis, chest wall, or pectoralis musculature
- Any evidence of nodal positivity beyond pathologic stage of pN0(i+)
- Systemic chemotherapy prior to final breast conserving surgery
- Patient is pregnant or nursing
- History of therapeutic irradiation to the breast, lower neck, mediastinum or other area in which there could potentially be overlap with the affected breast
- History of prior invasive or in situ cancer in either breast
- Current diagnosis of bilateral breast cancer
- History of lupus or scleroderma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (15)
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Community Cancer Center East
Indianapolis, Indiana, 46219, United States
Covenant Medical Center Harrison
Saginaw, Michigan, 48602, United States
Summit Medical Group
Berkeley Heights, New Jersey, 07922, United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103, United States
MD Anderson Cancer Center at Cooper-Voorhees
Voorhees Township, New Jersey, 08043, United States
Presbyterian Hospital
Albuquerque, New Mexico, 87106, United States
OhioHealth Mansfield Hospital
Mansfield, Ohio, 44903, United States
MD Anderson in The Woodlands
Conroe, Texas, 77384, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
MD Anderson West Houston
Houston, Texas, 77079, United States
MD Anderson League City
League City, Texas, 77573, United States
Saint Luke's Baptist Health System
San Antonio, Texas, 78229, United States
MD Anderson in Sugar Land
Sugar Land, Texas, 77478, United States
Related Publications (1)
Reddy JP, Lei X, Bloom ES, Reed VK, Schlembach PJ, Arzu I, Mayo L, Chun SG, Ahmad NR, Stauder MC, Gopal R, Kaiser K, Fang P, Smith BD; OPAL Trial Investigators. Optimizing Preventive Adjuvant Linac-Based (OPAL) Radiation: A Phase 2 Trial of Daily Partial Breast Irradiation. Int J Radiat Oncol Biol Phys. 2023 Mar 1;115(3):629-644. doi: 10.1016/j.ijrobp.2022.09.083. Epub 2022 Oct 8.
PMID: 36216274DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Benjamin D Smith
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2017
First Posted
March 13, 2017
Study Start
March 6, 2017
Primary Completion (Estimated)
November 8, 2027
Study Completion (Estimated)
November 8, 2027
Last Updated
March 5, 2026
Record last verified: 2026-03