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Hypofractionated vs. Conventional Regional Nodal Radiation Therapy for Patients With Invasive Breast Cancer

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ClinicalTrials.gov Identifier: NCT02912312
Recruitment Status : Recruiting
First Posted : September 23, 2016
Last Update Posted : June 3, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
Investigators are conducting a clinical trial to compare two different treatment schedules for women who need radiation therapy to their lymph nodes as part of their breast cancer treatment. Eligible patients will be randomly assigned to either a traditional radiation therapy schedule, which takes approximately 6 weeks to complete, or to an innovative, newer radiation therapy schedule, which takes approximately 4 weeks to complete. The available evidence suggests that both the traditional and the newer radiation schedules are highly effective for preventing recurrence. The main purpose of the trial is to see if the newer radiation treatment schedule will lower the risk of developing arm swelling, also known as lymphedema, after radiation treatment. We will also be studying the impact of the innovative, shorter, treatment on patient-reported arm function and quality of life.

Condition or disease Intervention/treatment Phase
Invasive Breast Carcinoma Stage I Breast Cancer AJCC v7 Stage IA Breast Cancer AJCC v7 Stage IB Breast Cancer AJCC v7 Stage II Breast Cancer AJCC v6 and v7 Stage IIA Breast Cancer AJCC v6 and v7 Stage IIB Breast Cancer AJCC v6 and v7 Stage IIIA Breast Cancer AJCC v7 Stage IIIC Breast Cancer AJCC v7 Radiation: Hypofractionated Radiation Therapy Other: Laboratory Biomarker Analysis Other: Quality-of-Life Assessment Other: Questionnaire Administration Radiation: Radiation Therapy Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Shortening Adjuvant Photon Irradiation to Reduce Edema (SAPHIRE): A Randomized Trial of Hypofractionated Versus Conventionally Fractionated Regional Nodal Irradiation for Invasive Breast Cancer
Actual Study Start Date : February 23, 2017
Estimated Primary Completion Date : February 28, 2030
Estimated Study Completion Date : February 28, 2031

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Arm I: Hypofractionated Regional Nodal Irradiation (RNI)
Patients undergo hypofractionated RNI in 15 fractions 5 consecutive days a week for 3 weeks. Patients also undergo additional boost dose of radiation therapy in 5 or 7 fractions on consecutive days following completion of RNI.
Radiation: Hypofractionated Radiation Therapy
Undergo hypofractionated RNI
Other Names:
  • Hypofractionated Radiotherapy
  • hypofractionation

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Active Comparator: Arm II: Standard Regional Nodal Irradiation (RNI)
Patients undergo standard RNI in 25 fractions 5 consecutive days a week for 5 weeks. Patients also undergo additional boost dose of radiation therapy in 5 or 7 fractions on consecutive days following completion of RNI.
Other: Laboratory Biomarker Analysis
Correlative studies

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Radiation: Radiation Therapy
Undergo standard RNI
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • irradiation
  • Radiation
  • Radiotherapeutics
  • RADIOTHERAPY
  • RT
  • Therapy, Radiation




Primary Outcome Measures :
  1. Lymphedema rate as assessed by perometry [ Time Frame: Up to 24 months ]
    Will compare between patients randomized to short versus standard regional nodal irradiation (RNI). Will use a two-sided chi-squared test with a significance level of 0.05.


Secondary Outcome Measures :
  1. Volume of affected and unaffected arm as assessed by perometry [ Time Frame: Up to 126 months ]
    The Shapiro-Wilk test will be used to objectively assess the normality of the data and these findings will be visually confirmed by inspecting normal probability quantile-quantile plots. If the data are not normally distributed, a normalizing transformation before using t-test or a non-parametric method such as the Wilcoxon rank sum test to compare the standardized difference between the two arms at each time point may be used.



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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:

  • POSTOPERATIVE RADIATION THERAPY: Radiation oncologist recommends radiation treatment to the supraclavicular and infraclavicular fossa (i.e. RNI)
  • POSTOPERATIVE RADIATION THERAPY: Pathologically-confirmed invasive breast cancer; if patients undergo upfront surgery, the pathologic stage must be T0-T3, N0-N2a or N3a; if patients receive neoadjuvant chemotherapy prior to surgery, the clinical stage must be T0-T3, N0-N2a or N3a
  • POSTOPERATIVE RADIATION THERAPY: Treatment with mastectomy or segmental mastectomy and axillary evaluation (sentinel node evaluation, axillary sampling, or axillary lymph node dissection); if the patient has T0 disease, breast surgery is not required
  • POSTOPERATIVE RADIATION THERAPY: Documentation of arm volume measurement by perometer prior to axillary surgery
  • POSTOPERATIVE RADIATION THERAPY: If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration, and the patient must have no evidence of disease for this prior non-breast cancer
  • POSTOPERATIVE RADIATION THERAPY: Patients must be enrolled on the trial within 12 weeks of the later of two dates: the final breast cancer surgical procedure or administration of the last cycle of cytotoxic chemotherapy
  • PREOPERATIVE RADIATION THERAPY: Surgeon and radiation oncologist recommend preoperative radiation therapy
  • PREOPERATIVE RADIATION THERAPY: Pathologically-confirmed invasive breast cancer. The clinical stage must be T0-T3, N0-N3a
  • PREOPERATIVE RADIATION THERAPY: Planned treatment with mastectomy and axillary evaluation (sentinel node evaluation, axillary sampling, or axillary lymph node dissection)
  • PREOPERATIVE RADIATION THERAPY: If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration, and the patient must have no evidence of disease for this prior non-breast cancer

Exclusion Criteria:

  • Pathologic or clinical evidence for a stage T4 breast cancer
  • Pathologic or clinical evidence for a stage N2b, N3b, or N3c breast cancer (supraclavicular, or internal mammary lymph node involvement)
  • Clinical or pathologic evidence for distant metastases
  • Any prior diagnosis of invasive or ductal carcinoma in situ breast cancer in either breast
  • Current diagnosis of bilateral breast cancer
  • History of therapeutic irradiation to the breast, lower neck, mediastinum or other area in which there could potentially be overlap with the affected breast
  • Patient is pregnant

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): NCT02912312


Contacts
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Contact: Karen Hoffman, MD 713-563-2331 khoffman1@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Karen E. Hoffman, MD    713-563-2331      
Principal Investigator: Karen E. Hoffman, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Karen Hoffman, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02912312     History of Changes
Other Study ID Numbers: 2016-0142
NCI-2016-01941 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2016-0142 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Breast cancer
hypofractionation
radiation therapy
regional nodal irradiation
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases