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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02637024
Recruitment Status : Active, not recruiting
First Posted : December 22, 2015
Last Update Posted : August 31, 2021
Sponsor:
Collaborator:
Canadian Breast Cancer Foundation
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)

Tracking Information
First Submitted Date  ICMJE December 16, 2015
First Posted Date  ICMJE December 22, 2015
Last Update Posted Date August 31, 2021
Actual Study Start Date  ICMJE May 2016
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2015)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Radiation Fractionation Schedules for Once-a-Day Accelerated Partial Breast Irradiation
Official Title  ICMJE A Phase II Randomized Trial of Radiation Fractionation Schedules for Once-a-Day Accelerated Partial Breast Irradiation (OPAR)
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).
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • DCIS
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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
    Intervention: Radiation: APBI: 30 Gy
  • 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
    Intervention: Radiation: APBI: 27.5 Gy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 17, 2015)
280
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02637024
Other Study ID Numbers  ICMJE OCOG-2015-OPAR
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ontario Clinical Oncology Group (OCOG)
Study Sponsor  ICMJE Ontario Clinical Oncology Group (OCOG)
Collaborators  ICMJE Canadian Breast Cancer Foundation
Investigators  ICMJE
Principal Investigator: Do-Hoon Kim, MD Juravinski Cancer Centre
PRS Account Ontario Clinical Oncology Group (OCOG)
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP