Status:
ENROLLING_BY_INVITATION
Local and Regional Radiotherapy for Nipple Sparing Mastectomy With Implant
Lead Sponsor:
National Cancer Center, Korea
Conditions:
Breast Cancer
Eligibility:
FEMALE
20+ years
Brief Summary
The prospective observational study of radiation therapy is conducted on the nipple-areola complex(close resection margin at primary tumor site) or regional lymph nodes(including axilla and supraclavi...
Detailed Description
For the last 20years, Breast Conservation Surgery and postoperative radiotherapy were the well established standard treatment, proven by various clinical trial studies, About 20-50% of breast cancer p...
Eligibility Criteria
Inclusion
- patient who have pathologic confirmation of Ductal carcinoma in situ or invasive caricinoma
- patient who undergone nipple sparing mastectomy with construction
- patient who considered radiotherapy in breast cancer at stage IIB or lower (exclude ≥T3, ≥N2)
- patient who have not distant metastasis
- age \>19 years old
- patinet who have an ECOG of 0-2
- patient who have not comorbidities(collagne vascular disease, such as systemic lupus erythermatosis, scleroderma, dermatomyositis)
- patient who have not prior radiotherapy history in treatment site
- patient who have not pregnancy or lacting
- patient who have consent in writing to participate in research
Exclusion
- patient who undergone construction after nipple sparing mastectomy
- patient who have ≥T3, ≥N2 in breast cancer
- patient who have diastant metastasis
- patient who have comorbidities(collagne vascular disease, such as systemic lupus erythermatosis, scleroderma, dermatomyositis)
- patient who have treatment history in treatment site
- patinet who have an ECOG 3-4
- age \< 20years old
- patient who have pregnancy or lacting
- patient who have not consent in writing to participate in research
Key Trial Info
Start Date :
November 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT05213962
Start Date
November 15 2021
End Date
December 31 2028
Last Update
January 28 2022
Active Locations (1)
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1
National Cancer Center Korea
Goyang-si, Gyeonggi-do, South Korea, 410-769