RecruitingNot ApplicableNCT03909282

Surgical Excision vs Neoadjuvant Radiotherapy+Delayed Surgical Excision of Ductal Carcinoma

A Randomized Phase II Study Comparing Surgical Excision Versus Neoadjuvant Radiotherapy Followed by Delayed Surgical Excision of Ductal Carcinoma In Situ (NORDIS)


Sponsor

Stanford University

Enrollment

50 participants

Start Date

Mar 22, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this pilot study is to compare by pathological findings surgical excision versus neoadjuvant radiotherapy followed by delayed surgical excision of ductal carcinoma in situ (DCIS)


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing standard surgery alone versus a short course of radiation before surgery for ductal carcinoma in situ (DCIS) — a non-invasive type of breast cancer found on imaging — to see if pre-surgery radiation reduces the chance of cancer coming back. **You may be eligible if...** - You are a woman 18 or older - You have been diagnosed with DCIS detected by mammogram or MRI (not felt as a lump) - The DCIS area measures 4 cm or less - Your diagnosis was made within the last 16 weeks and a biopsy marker has been placed in the tumor area **You may NOT be eligible if...** - Your DCIS was felt as a palpable lump - You have invasive breast cancer - You have had prior breast radiation or relevant prior surgeries Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURELumpectomy

Standard of Care surgery for DCIS (either lumpectomy or mastectomy)

RADIATIONPartial breast irradiation prior to surgery

Partial breast irradiation (PBI) will be delivered once aday for 5 days. The planned daily dose is 6 Gy prior to surgery (neo adjuvant)


Locations(1)

Stanford University

Stanford, California, United States

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NCT03909282


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