N/A
N=97
Study of Prone Accelerated Breast And Nodal IMRT
Lymphedema
Bottom Line
View on ClinicalTrials.gov: NCT02308488 ↗Enrolled (actual)
97
Serious AEs
1.1%
Results posted
Aug 2022
Primary outcome: Primary: Number of Participants With Acute Toxicity > Grade 2 (Skin Toxicity Grade 3 or Above) Occurring Within 60 Days After First Day of Treatment — 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intensity-modulated radiation therapy (IMRT) (Radiation)
- Age
- Adult, Older Adult · 36+ yrs
- Sex
- Female
- Sponsor
- NYU Langone Health
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Acute Toxicity > Grade 2 (Skin Toxicity Grade 3 or Above) Occurring Within 60 Days After First Day of Treatment |
4 | — |
| PRIMARY Number of Participants Who Met Constraints |
95 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02308488). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.