Partial Breast Irradiation for Low-risk Ductal Carcinoma In Situ After Breast-conserving Surgery
Phase II Study of Partial Breast Irradiation for Low-risk Ductal Carcinoma In Situ After Breast-conserving Surgery
1 other identifier
observational
828
1 country
1
Brief Summary
This study is designed to evaluate the feasibility and safety of partial breast irradiation for low risk DCIS after breast-conserving surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 21, 2015
CompletedFirst Posted
Study publicly available on registry
November 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedNovember 30, 2015
November 1, 2015
4 years
November 21, 2015
November 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ipsilateral breast tumor recurrence
5 years
Secondary Outcomes (5)
occurrence of contralateral breast tumor after PBI
5 years
Disease free survival
5 years
Overall survival
5 years
radiation-induced toxicity of breast assessed by CTCAE v4.0
baseline, 3 months, 6 months, and every half year to 5 years
Complications
baseline，1，2，3，4，5 years
Study Arms (1)
partial breast irradiation
Interventions
The prescription dose is 40.5Gy in 15 fractions in 3 weeks.
Eligibility Criteria
DCIS breast cancer patients
You may qualify if:
- Female
- \~65 years old
- Pathologically confirmed DCIS, low- or intermediate- grade DCIS: (lesions of ≤2.5 cm diameter, resection margins of at least 3 mm, nuclei grade: 1-2), high grade DCIS: (lesions of ≤1 cm diameter, resection margins of at least 3 mm, nuclei grade: 3)
- Treated with breast conserving surgery
- Tumor bed is labeled with Titanium clips
- No malignancy history
- ECOG score 0\~1
- Written informed consent
You may not qualify if:
- DCIS of both breast
- invasive breast cancer
- Multicentric disease
- Patients underwent mastectomy
- Previous radiation therapy of breast
- Medical contraindication for radiotherapy
- Pregnant or nursing
- suspicious calcification after surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Biospecimen
blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaoli Yu, MD.PhD
Fudan University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
November 21, 2015
First Posted
November 30, 2015
Study Start
October 1, 2015
Primary Completion
October 1, 2019
Last Updated
November 30, 2015
Record last verified: 2015-11