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Intensity Modulated Radiation Therapy or 3-Dimensional Conformal Radiation Therapy in Treating Patients With Lymph-Node Positive Breast Cancer

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ClinicalTrials.gov Identifier: NCT03786354
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jose Bazan, Ohio State University Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
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 Radiation: 3-Dimensional Conformal Radiation Therapy Radiation: Intensity-Modulated Radiation Therapy Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Shoulder Morbidity in Patients With Lymph-Node Positive Breast Cancer Receiving Regional Nodal Irradiation
Actual Study Start Date : December 31, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Arm A (IMRT)
Patients undergo Intensity-Modulated Radiation Therapy over 5 weeks.
Radiation: Intensity-Modulated Radiation Therapy
Undergo IMRT
Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy

Experimental: Arm B (3DCRT)
Patients undergo 3-Dimensional Conformal Radiation Therapy over 5 weeks.
Radiation: 3-Dimensional Conformal Radiation Therapy
Undergo 3DCRT
Other Names:
  • 3-dimensional radiation therapy
  • 3D CONFORMAL RADIATION THERAPY
  • 3D CRT
  • 3D-CRT
  • Conformal Therapy
  • Radiation Conformal Therapy




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Shoulder/arm morbidity assessed by DASH questionnaire in patients treated with 3-dimensional conformal radiation therapy (3DCRT) [ Time Frame: At 1 year ]
    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.

  2. 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 ]
    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

  3. 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 arm circumference using a tape measure

  4. Measure rates of upper extremity lymphedema using a perometer [ Time Frame: At baseline, 1 month, 6 months and 12 months post-radiation ]
    Measure rates of upper extremity lymphedema using arm circumference using a perometer

  5. Dosimetric parameters associated with worse arm/shoulder morbidity as measured by the DASH [ Time Frame: Up to 5 years ]
    Dosimetric parameters (the volume of shoulder receiving 5-50 Gy) associated with worse arm/shoulder morbidity as measured by the DASH

  6. Rates of loco-regional control in patients treated with IMRT [ Time Frame: At 5 years ]
    Rates of loco-regional control, distant metastases, and overall survival in patients treated with IMRT

  7. Distant metastases in patients treated with IMRT [ Time Frame: At 5 years ]
    The cumulative incidence of distant metastases at 5 years in patients treated with IMRT control, distant metastases

  8. Overall survival in patients treated with IMRT [ Time Frame: Up to 5 years ]
    Kaplan-Meier method will be used to estimate the 5-year overall survival in patients treated with IMRT

  9. Shoulder/arm morbidity using the DASH questionnaire in patients treated with IMRT [ Time Frame: Up to 5 years ]
    DASH questionnaire in patients treated with IMRT to assess shoulder/arm morbidity using full scale range 0-100

  10. Shoulder/arm morbidity using the DASH questionnaire in patients treated with 3DCRT [ Time Frame: Up to 5 years ]
    DASH questionnaire in patients treated with 3DCRT to assess shoulder/arm morbidity



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786354


Contacts
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Contact: The Ohio State University Comprehensive Cancer Center 1-800-293-5066 OSUCCCClinicaltrials@osumc.edu

Locations
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United States, Ohio
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Jose G. Bazan    614-688-7371    jose.bazan2@osumc.edu   
Principal Investigator: Jose G. Bazan         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jose Bazan, MD, MS Ohio State University Comprehensive Cancer Center

Additional Information:
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Responsible Party: Jose Bazan, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03786354     History of Changes
Other Study ID Numbers: OSU-18201
NCI-2018-02307 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA016058 ( U.S. NIH Grant/Contract )
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases