Anatomic Stage II Breast Cancer AJCC v8NCT03786354
Intensity Modulated Radiation Therapy or 3-Dimensional Conformal Radiation Therapy in Treating Patients With Lymph-Node Positive Breast Cancer
A study testing 3-Dimensional Conformal Radiation Therapy and Intensity-Modulated Radiation Therapy in people with Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage IIA Breast Cancer AJCC v8, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8
- What is being tested?
- 3-Dimensional Conformal Radiation Therapy and Intensity-Modulated Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2019to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 10Show fewer
- Prior radiotherapy to the breast or prior radiation to the region of the ipsilateral breast that would result in overlap of radiation fields
- Medical, psychiatric, or other conditions that would prevent the patient from receiving the protocol therapy or providing informed consent
- Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception
- Active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Prospective Evaluation of Shoulder Morbidity in Patients With Lymph-Node Positive Breast Cancer Receiving Regional Nodal Irradiation
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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.
- Conditions
- Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8
- Being tested
- 3-Dimensional Conformal Radiation Therapy, Intensity-Modulated Radiation Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-Dimensional Conformal Radiation TherapyRadiation
Also called 3-dimensional radiation therapy, 3D CONFORMAL RADIATION THERAPY, 3D CRT, 3D-CRT
Undergo 3DCRT
Intensity-Modulated Radiation TherapyRadiation
Also called IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy
Undergo IMRT
| Study group | Role | What they receive |
|---|---|---|
| Arm A (IMRT) | Experimental | Patients undergo Intensity-Modulated Radiation Therapy over 5 weeks. Receives: Radiation: Intensity-Modulated Radiation Therapy |
| Arm B (3DCRT) | Experimental | Patients undergo 3-Dimensional Conformal Radiation Therapy over 5 weeks. Receives: Radiation: 3-Dimensional Conformal Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 1 year
Secondary outcomes (10)
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.
Measured: At 1 year
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start9 Jan 2019
- Primary completion6 Feb 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage II Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sasha Beyer, Ohio State University Comprehensive Cancer Center
- Investigators
- Sasha Beyer, MD, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786354
- Sponsor's protocol ID
- OSU-18201
- Other IDs
- NCI-2018-02307
- Status last verified
- Feb 2026
- First submitted
- 19 Dec 2018
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Shoulder Morbidity in Patients With Lymph-Node Positive Breast Cancer Receiving Regional Nodal Irradiation
- ClinicalTrials.gov ID
- NCT03786354
- Acronym / sponsor ID
- OSU-18201
- Conditions
- Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 9 Jan 2019 (actual)
- Primary completion
- 6 Feb 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (IMRT) | Experimental | Radiation: Intensity-Modulated Radiation TherapyPatients undergo Intensity-Modulated Radiation Therapy over 5 weeks. |
| Arm B (3DCRT) | Experimental | Radiation: 3-Dimensional Conformal Radiation TherapyPatients undergo 3-Dimensional Conformal Radiation Therapy over 5 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3-Dimensional Conformal Radiation TherapyAlso: 3-dimensional radiation therapy, 3D CONFORMAL RADIATION THERAPY, 3D CRT, 3D-CRTUndergo 3DCRT | Radiation | Arm B (3DCRT) |
| Intensity-Modulated Radiation TherapyAlso: IMRT, Intensity Modulated RT, Intensity-Modulated RadiotherapyUndergo IMRT | Radiation | Arm A (IMRT) |
Primary outcome
Shoulder/arm morbidity assessed by Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire in patients treated with intensity modulated radiation therapy (IMRT)
Time frame: At 1 year
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.
10 secondary outcomes
Shoulder/arm morbidity assessed by DASH questionnaire in patients treated with 3-dimensional conformal radiation therapy (3DCRT)
Time frame: At 1 year
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
Time frame: At baseline, 1 month, 6 months and 12 months post-radiation
Measure rates of upper extremity lymphedema using arm circumference with a tape measure
Time frame: At baseline, 1 month, 6 months and 12 months post-radiation
Measure rates of upper extremity lymphedema using a perometer
Time frame: At baseline, 1 month, 6 months and 12 months post-radiation
Dosimetric parameters associated with worse arm/shoulder morbidity as measured by the DASH
Time frame: Up to 5 years
Rates of loco-regional control in patients treated with IMRT
Time frame: At 5 years
Distant metastases in patients treated with IMRT
Time frame: At 5 years
Overall survival in patients treated with IMRT
Time frame: Up to 5 years
Shoulder/arm morbidity using the DASH questionnaire in patients treated with IMRT
Time frame: Up to 5 years
Shoulder/arm morbidity using the DASH questionnaire in patients treated with 3DCRT
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sasha Beyer, MD, PhD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-Dimensional Conformal Radiation Therapy and Intensity-Modulated Radiation Therapy in people with Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage IIA Breast Cancer AJCC v8, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder/arm morbidity assessed by Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire in patients treated with intensity modulated radiation therapy (IMRT) (time frame: At 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.