Local and Regional Radiotherapy for Nipple Sparing Mastectomy With Implant

NCT05213962 | Enrolling By Invitation

• 1 other identifier: NCC2021-0335
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

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 supraclavicular lymph node) with a high risk of local recurrence in nipple-sparing mastectomy with reconstruction, we're going to analysis the effects of radiation therapy and cosmetic effects. By evaluating survival rate, recurrence pattern(local lymph node and metastasis to the whole body), side effects, cosmetic effects, from the patients who have gone through Nipple Sparing Mastectomy with reconstruction.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• freedom from local and regioanl recurrence rate : FFLRR rate

  evaluate the freedom from local and regioanl recurrence rate in nipple-areola complex(close resection margin at primary tumor site) or regional lymph nodes(including axilla and supraclavicular lymph node)

  up to 5 years

Secondary Outcomes (2)

• relapse-free or overall survivor : RFS and OS

  up to 5 years

• toxicity and contraction of the implant, quality of life

  up to 5 years

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Breast cancer patients receiving nipple sparing mastectomy with breast reconstruction

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center Korea

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Tae hyun Kim, Ph.D

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 28, 2022
• Study Start: November 15, 2021
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 28, 2022

Record last verified: 2022-01

Locations

KR (1)