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Randomized Trial of Accelerated Partial Breast Irradiation

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: NCT03583619
Recruitment Status : Completed
First Posted : July 11, 2018
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Shu lian Wang, Chinese Academy of Medical Sciences

Study Description
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Brief Summary:
This study is to compare radiation toxicity of accelerated partial breast irradiation (ABPI) with whole breast irradiation (WBI) in low-risk breast cancer.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Neoplasm Recurrence, Local Radiation: APBI Radiation: WBI Not Applicable

Detailed Description:
This study is a single-center phase II randomized clinical trial to enroll low-risk breast cancer treat with breast-conserving surgery. All eligible patients are randomized to receive either ABPI (40Gy/10fx/2wks) or WBI(43.5Gy/15fx/3wks). Intensity modulated radiation therapy (IMRT) technique is used. Grade 2 or more acute and late toxicities are prospectively evaluated and compared.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Randomized Clinical Trial of Accelerated Partial Breast Irradiation Compared With Whole Breast Irradiation With IMRT in Early Breast Cancer
Actual Study Start Date : July 19, 2017
Actual Primary Completion Date : January 11, 2019
Actual Study Completion Date : March 23, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: APBI
Patients receive accelerated partial breast irradiation to tumour bed to a total dose of 40Gy, 4.0Gy per fraction, 5 fractions a week, within 2 weeks.
 Radiation: APBI
Patients receive radiation to the breast tumor bed to a total dose of 40Gy/10fx/2wks, using intensity-modulated radiation therapy technique.
Active Comparator: WBI
Patients receive whole breast irradiation to a total dose of 43.5Gy, at 2.9Gy per fraction, 5 fractions a week, within 3 weeks.
 Radiation: WBI
Patients receive radiation to the whole breast to a total dose of 43.5Gy/15fx/3wks, using intensity-modulated radiation therapy technique.


Outcome Measures
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Primary Outcome Measures :
  1. Number o participants with Grade 2 or more toxicity [ Time Frame: 5 years ]

    The evaluated toxicities include the following and are evaluated by CTCAE 3.0 criteria:

    acute skin toxicity,breast swelling, breast pain,radiation pneumonitis, cardiac toxicity, pulmonary fibrosis, cosmetic result



Secondary Outcome Measures :
  1. locoregional recurrence [ Time Frame: 5 years ]
    ipsilateral breast and axillary nodal recurrence

  2. overall survival [ Time Frame: 5 years ]
    any death

  3. disease-free survival [ Time Frame: 5 years ]
    any recurrence or death

  4. distant-metastasis survival [ Time Frame: 5 years ]
    distant metastasis

  5. Quality of life measured with BR-23 questionnaire [ Time Frame: 2 years ]
    BR-23 questionnaire


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Life Expectation: > 5 years
  • Enrollment date no more than 12 weeks after breast-conserving surgery or no more than 8 weeks after adjuvant chemotherapy
  • Histologically confirmed diagnosis of invasive ductal carcinoma (grade 1-2), or mucinous carcinoma, or papillary carcinoma, or tubular carcinoma, or medullary carcinoma: primary tumor ≤ 3.0cm in maximum diameter and pN0; or histologically confirmed DCIS: primary tumor ≤ 2.5cm in maximum diameter, low-medium grade
  • Unifocal tumour (confirmed by diagnostic MRI)
  • No lymphovascular invasion
  • ER positive (defined as medium-strongly nuclear staining in >1% of the cancer cells)
  • Negative radial resection margins of >= 2 mm
  • Surgical clips placed in the tumor bed
  • Written informed consent.

Exclusion Criteria:

  • Stage Ⅱ-Ⅲ
  • Multifocal tumors
  • Histologically confirmed diagnosis of invasive ductal carcinoma (grade 3), - - - invasive micropapillary carcinoma, carcinoma of lobular in situ, invasive - - - lobular carcinoma
  • Paget's disease of the nipple
  • Underwent oncoplastic surgery of ipsilateral breast
  • Underwent neoadjuvant chemotherapy or hormonal therapy
  • Previous or simultaneous contralateral breast cancer
  • Undergone ipsilateral chest wall radiotherapy
  • Active collagen vascular disease.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT03583619


Locations
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China, Beijing
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing, China, 100021
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
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Principal Investigator: Shulian Wang, M.D. National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Shu lian Wang, Professor, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03583619    
Other Study ID Numbers: NCC-000498
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Breast Neoplasms
Neoplasm Recurrence, Local
Recurrence
Disease Attributes
 Pathologic Processes
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes