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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-02307 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
PRIMARY OBJECTIVES:
I. To determine if intensity modulated radiation therapy (IMRT) reduces average 1-year patient-reported shoulder/arm morbidity in women receiving regional nodal irradiation (RNI) for lymph-node positive breast cancer as compared to historical data.
SECONDARY OBJECTIVES:
I. To measure patient-reported shoulder/arm morbidity in women receiving RNI with 3-dimensional conformal radiation therapy (3DCRT) for lymph-node positive breast cancer.
II. To measure change in shoulder range of motion in women receiving RNI. III. To measures rates of ipsilateral upper extremity lymphedema in women receiving RNI.
IV. To explore the dose volume parameters to the shoulder/neck/trunk musculature associated with worsening patient-reported shoulder/arm morbidity.
V. To assess disease outcomes in patients treated with IMRT. VI. To measure long-term patient-reported shoulder/arm morbidity in women receiving RNI with IMRT or 3DCRT.
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM A: Patients undergo IMRT over 5 weeks.
ARM B: Patients undergo 3DCRT over 5 weeks.
After completion study treatment, patients are followed up at 1, 6, and 12 months, and then annually for up to 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (IMRT) | Experimental | Patients undergo Intensity-Modulated Radiation Therapy over 5 weeks. |
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| Arm B (3DCRT) | Experimental | Patients undergo 3-Dimensional Conformal Radiation Therapy over 5 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3-Dimensional Conformal Radiation Therapy | Radiation | Undergo 3DCRT |
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| Measure | Description | Time Frame |
|---|---|---|
| Shoulder/arm morbidity assessed by Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire in patients treated with intensity modulated radiation therapy (IMRT) | DASH questionnaire in patients treated with IMRT to assess shoulder/arm morbidity. Patients that have a DASH score of ≥15 at 1 year post-treatment will be considered as having persistent shoulder morbidity. The full scale range is 0-100. | At 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder/arm morbidity assessed by DASH questionnaire in patients treated with 3-dimensional conformal radiation therapy (3DCRT) | DASH questionnaire in patients treated with 3DCRT to assess shoulder/arm morbidity. Patients that have a DASH score of ≥15 at 1 year post-treatment will be considered as having persistent shoulder morbidity. | At 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sasha Beyer, MD, PhD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| Intensity-Modulated Radiation Therapy | Radiation | Undergo IMRT |
|
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| Changes in shoulder range of motion for flexion, abduction, internal and external rotation using a goniometer as defined by the American Academy of Orthopedic Surgeons | Using a goniometer as defined by the American Academy of Orthopedic Surgeons to measure changes in shoulder range of motion for flexion, abduction, internal and external rotation | At baseline, 1 month, 6 months and 12 months post-radiation |
| Measure rates of upper extremity lymphedema using arm circumference with a tape measure | Measure rates of upper extremity lymphedema using arm circumference using a tape measure | At baseline, 1 month, 6 months and 12 months post-radiation |
| Measure rates of upper extremity lymphedema using a perometer | Measure rates of upper extremity lymphedema using arm circumference using a perometer | At baseline, 1 month, 6 months and 12 months post-radiation |
| Dosimetric parameters associated with worse arm/shoulder morbidity as measured by the DASH | Dosimetric parameters (the volume of shoulder receiving 5-50 Gy) associated with worse arm/shoulder morbidity as measured by the DASH | Up to 5 years |
| Rates of loco-regional control in patients treated with IMRT | Rates of loco-regional control, distant metastases, and overall survival in patients treated with IMRT | At 5 years |
| Distant metastases in patients treated with IMRT | The cumulative incidence of distant metastases at 5 years in patients treated with IMRT control, distant metastases | At 5 years |
| Overall survival in patients treated with IMRT | Kaplan-Meier method will be used to estimate the 5-year overall survival in patients treated with IMRT | Up to 5 years |
| Shoulder/arm morbidity using the DASH questionnaire in patients treated with IMRT | DASH questionnaire in patients treated with IMRT to assess shoulder/arm morbidity using full scale range 0-100 | Up to 5 years |
| Shoulder/arm morbidity using the DASH questionnaire in patients treated with 3DCRT | DASH questionnaire in patients treated with 3DCRT to assess shoulder/arm morbidity | Up to 5 years |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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