Intensity Modulated Radiation Therapy or 3-Dimensional Conformal Radiation Therapy in Treating Pa… (NCT03786354) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Intensity Modulated Radiation Therapy or 3-Dimensional Conformal Radiation Therapy in Treating Patients With Lymph-Node Positive Breast Cancer
United States61 participantsStarted 2019-01-09
Plain-language summary
This phase II trial studies the shoulder morbidity in patients with lymph-node positive breast cancer receiving intensity modulated radiation therapy or 3-dimensional conformal radiation therapy. Intensity modulated radiation therapy may cause less shoulder/arm morbidity in patients with lymph-node positive breast cancer.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Pathologically proven diagnosis of breast cancer
* Patients that receive neoadjuvant systemic therapy (chemotherapy, anti-HER2 therapy, or endocrine therapy) are eligible
* History/physical examination within 60 days prior to study entry
* Patients who have undergone either a lumpectomy or mastectomy are eligible
* Patients that have undergone any type of breast reconstruction are eligible
* The interval between the date of last surgery or chemotherapy and registration must be =\< 84 days
* Women of childbearing potential must have a negative urine or serum pregnancy test within 14 days of start of radiation therapy
* Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy
* Patients must provide study specific informed consent prior to study entry
Exclusion Criteria:
* Clinical or radiologic evidence of distant metastases
* Patients with known unresected disease in the axillary apex or supraclavicular fossa
* Prior invasive or in-situ carcinoma of the breast (prior lobular breast carcinoma in situ \[LCIS\] is eligible)
* Prior surgery to the ipsilateral shoulder for any condition
* Baseline impaired mobility of the ipsilateral shoulder from a condition not related to the breast cancer surgery as determined by the treating physician
* Non-epithelial breast malignancies such as sarcoma/lymphoma
* Prior radiotherapy to the breast or prior radiation to t…
What they're measuring
1
Shoulder/arm morbidity assessed by Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire in patients treated with intensity modulated radiation therapy (IMRT)
Timeframe: At 1 year
Trial details
NCT IDNCT03786354
SponsorOhio State University Comprehensive Cancer Center