Back to resultsIntensity Modulated Radiation Therapy or 3-Dimensional Conformal Radiation Therapy in Treating Patients With Lymph-Node Positive Breast Cancer
Primary Purpose
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3-Dimensional Conformal Radiation Therapy
Intensity-Modulated Radiation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Anatomic Stage II Breast Cancer AJCC v8
Eligibility Criteria
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 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
Sites / Locations
- Ohio State University Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm A (IMRT)
Arm B (3DCRT)
Arm Description
Patients undergo Intensity-Modulated Radiation Therapy over 5 weeks.
Patients undergo 3-Dimensional Conformal Radiation Therapy over 5 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
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
Measure rates of upper extremity lymphedema using a perometer
Measure rates of upper extremity lymphedema using arm circumference using a perometer
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
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
Distant metastases in patients treated with IMRT
The cumulative incidence of distant metastases at 5 years in patients treated with IMRT control, distant metastases
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
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
Shoulder/arm morbidity using the DASH questionnaire in patients treated with 3DCRT
DASH questionnaire in patients treated with 3DCRT to assess shoulder/arm morbidity
Full Information
NCT ID
NCT03786354
First Posted
December 19, 2018
Last Updated
April 3, 2023
Sponsor
Ohio State University Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT03786354
Brief Title
Intensity Modulated Radiation Therapy or 3-Dimensional Conformal Radiation Therapy in Treating Patients With Lymph-Node Positive Breast Cancer
Official Title
Prospective Evaluation of Shoulder Morbidity in Patients With Lymph-Node Positive Breast Cancer Receiving Regional Nodal Irradiation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 9, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, Anatomic Stage IIIC Breast Cancer AJCC v8, Lymph Node Involvement, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A (IMRT)
Arm Type
Experimental
Arm Description
Patients undergo Intensity-Modulated Radiation Therapy over 5 weeks.
Arm Title
Arm B (3DCRT)
Arm Type
Experimental
Arm Description
Patients undergo 3-Dimensional Conformal Radiation Therapy over 5 weeks.
Intervention Type
Radiation
Intervention Name(s)
3-Dimensional Conformal Radiation Therapy
Other Intervention Name(s)
3-dimensional radiation therapy, 3D CONFORMAL RADIATION THERAPY, 3D CRT, 3D-CRT, Conformal Therapy, Radiation Conformal Therapy
Intervention Description
Undergo 3DCRT
Intervention Type
Radiation
Intervention Name(s)
Intensity-Modulated Radiation Therapy
Other Intervention Name(s)
IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy
Intervention Description
Undergo IMRT
Primary Outcome Measure Information:
Title
Shoulder/arm morbidity assessed by Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire in patients treated with intensity modulated radiation therapy (IMRT)
Description
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.
Time Frame
At 1 year
Secondary Outcome Measure Information:
Title
Shoulder/arm morbidity assessed by DASH questionnaire in patients treated with 3-dimensional conformal radiation therapy (3DCRT)
Description
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.
Time Frame
At 1 year
Title
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
Description
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
Time Frame
At baseline, 1 month, 6 months and 12 months post-radiation
Title
Measure rates of upper extremity lymphedema using arm circumference with a tape measure
Description
Measure rates of upper extremity lymphedema using arm circumference using a tape measure
Time Frame
At baseline, 1 month, 6 months and 12 months post-radiation
Title
Measure rates of upper extremity lymphedema using a perometer
Description
Measure rates of upper extremity lymphedema using arm circumference using a perometer
Time Frame
At baseline, 1 month, 6 months and 12 months post-radiation
Title
Dosimetric parameters associated with worse arm/shoulder morbidity as measured by the DASH
Description
Dosimetric parameters (the volume of shoulder receiving 5-50 Gy) associated with worse arm/shoulder morbidity as measured by the DASH
Time Frame
Up to 5 years
Title
Rates of loco-regional control in patients treated with IMRT
Description
Rates of loco-regional control, distant metastases, and overall survival in patients treated with IMRT
Time Frame
At 5 years
Title
Distant metastases in patients treated with IMRT
Description
The cumulative incidence of distant metastases at 5 years in patients treated with IMRT control, distant metastases
Time Frame
At 5 years
Title
Overall survival in patients treated with IMRT
Description
Kaplan-Meier method will be used to estimate the 5-year overall survival in patients treated with IMRT
Time Frame
Up to 5 years
Title
Shoulder/arm morbidity using the DASH questionnaire in patients treated with IMRT
Description
DASH questionnaire in patients treated with IMRT to assess shoulder/arm morbidity using full scale range 0-100
Time Frame
Up to 5 years
Title
Shoulder/arm morbidity using the DASH questionnaire in patients treated with 3DCRT
Description
DASH questionnaire in patients treated with 3DCRT to assess shoulder/arm morbidity
Time Frame
Up to 5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sasha Beyer, MD, PhD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamesline
Learn more about this trial
Intensity Modulated Radiation Therapy or 3-Dimensional Conformal Radiation Therapy in Treating Patients With Lymph-Node Positive Breast Cancer
We'll reach out to this number within 24 hrs