CompletedNot Applicable

Study of Prone Accelerated Breast And Nodal IMRT

United States97 participantsStarted 2009-09

Plain-language summary

Following consent, patients will receive 15 fractions of radiotherapy to the affected breast and to Axillary level III and SCV (Supra-Clavicular) lymph nodes, defined by CT imaging obtained in a prone position using IMRT(intensity modulation radiation therapy ) technique: one fraction daily for 5 days/week for 3 consecutive weeks. Patients will be seen for follow-up at 45-60 days from first radiotherapy treatment, and then yearly. Patients will be assessed for Lymphedema at baseline, end of treatment, and at yearly intervals after completion of radiotherapy. All patients will be followed for toxicity and outcome (local and systemic recurrence, survival). In addition, patients will complete a self-assessment of QOL at baseline, week 3, day 45-60 and 2-yr follow-ups.

Who can participate

Age range36 Years – 90 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Pre- or post-menopausal women with stage II - III breast cancer (AJCC 2002) * Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm * Status post segmental mastectomy or mastectomy and axillary node dissection with removal of at least 8 nodes * One to 5 involved lymph nodes identified at axillary staging * At least 2 weeks from last chemotherapy or before chemotherapy * No more than sixty days from final surgery to simulation if no systemic therapy (includes chemotherapy and Hormonal therapy) is given * Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document Exclusion Criteria: * Previous radiation therapy to the ipsilateral breast * More than 5 involved nodes identified at axillary staging * Current treatment for active connective tissue disorders, such as lupus or scleroderma * Pregnant or lactating women * Less than 35 years old

What they're measuring

Number of Participants With Acute Toxicity > Grade 2 (Skin Toxicity Grade 3 or Above) Occurring Within 60 Days After First Day of Treatment

Timeframe: Day 60

Number of Participants Who Met Constraints

Timeframe: Day 60

Trial details

NCT IDNCT02308488

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09-17

Results submitted2022-07-07