Trial of Radiation Fractionation Schedules for Once-a-Day Accelerated Partial Breast Irradiation (OPAR)
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|ClinicalTrials.gov Identifier: NCT02637024|
Recruitment Status : Active, not recruiting
First Posted : December 22, 2015
Last Update Posted : August 31, 2021
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer DCIS||Radiation: APBI: 30 Gy Radiation: APBI: 27.5 Gy||Phase 2|
Women with invasive carcinoma of the breast with negative axillary nodes or DCIS, following BCS and/or chemotherapy, who meet the inclusion criteria will be screened and approached for eligibility assessment and potential study enrollment. All potentially eligible and consenting patients who do not meet the exclusion criteria will have a Computed Tomography (CT) simulation of the ipsilateral breast prior to randomization. All cases will be required to be planned prior to the randomization to ensure that dosimetric coverage and normal tissue restrictions can be met. If the seroma is not clearly visible or if the surgical clips do not adequately identify a previous surgical cavity, the patient will not be eligible for randomization.
Eligible, consenting patients will be randomly allocated to receive radiotherapy of 3DCRT APBI 30Gy 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 using the EORTC Breast Cosmetic Rating System. Radiation toxicity will be assessed using the NCI CTCAE version 4.02. The primary outcome is adverse cosmetic outcome at 2 years. The trial will be conducted in clinical centres within Canada.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||280 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Phase II Randomized Trial of Radiation Fractionation Schedules for Once-a-Day Accelerated Partial Breast Irradiation (OPAR)|
|Actual Study Start Date :||May 2016|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2023|
Experimental: APBI: 30 Gy
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
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.
Experimental: APBI: 27.5 Gy
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
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.
- Adverse cosmetic outcome using the EORTC Breast Cosmetic Rating System [ Time Frame: 2 years post randomization ]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.
- Cosmetic deterioration (defined as any adverse change in the global cosmetic score) [ Time Frame: Baseline to two years ]defined as any adverse change in the global cosmetic score from baseline to 2 years. Subjects with global cosmetic scores that were stable or improved from baseline to 2 years will be scored as 'no deterioration'.
- Radiation toxicity assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.4.02 [ Time Frame: 12, 24, 36 and 60 months ]defined as breast induration/fibrosis, shrinkage, and telangiectasia, which will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.4.02.
- Ipsilateral breast tumour recurrence (IBTR) [ Time Frame: Ongoing throughout study up to 5 years ]defined as recurrent invasive or in situ cancer in the ipsilateral breast including the axillary tail. Histological evidence of local recurrence will be required.
- Disease free survival (DFS) [ Time Frame: Ongoing throughout study up to 5 years ]defined as the time from randomization to the time of documented recurrent disease in the ipsilateral breast or regional nodes (supraclavicular, axillary or internal mammary) or distant sites (e.g. bone, liver, lung or brain).
- Overall survival (OS) [ Time Frame: From date of randomization until the date of death up to 5 years ]defined as the time from randomization to death from any cause.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02637024
|Simcoe Muskoka Regional Cancer Centre, Royal Victoria Hospital|
|Barrie, Ontario, Canada, L4M 6M2|
|Juravinski Cancer Centre|
|Hamilton, Ontario, Canada, L8V5C2|
|Grand River Regional Cancer Centre|
|Kitchener, Ontario, Canada, N2G 1G3|
|London Regional Cancer Program; London Health Sciences Centre|
|London, Ontario, Canada, N6A4L6|
|Odette Cancer Centre, Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Windsor Regional Cancer Centre|
|Windsor, Ontario, Canada, N8W 2X3|
|Montreal, Quebec, Canada, H1T 2M4|
|CHUM Centre Hospitalier de L'Université de Montréal|
|Montreal, Quebec, Canada, H2L 4M1|
|CHUQ Pavillon Hotel-Dieu Quebec|
|Quebec City, Quebec, Canada, G1R 2J6|
|CHUS - Hopital Fleurimont|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Principal Investigator:||Do-Hoon Kim, MD||Juravinski Cancer Centre|