Hypofractionated Regional Nodal Irradiation Clinical Trial for Women With Breast Cancer
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|ClinicalTrials.gov Identifier: NCT02515110|
Recruitment Status : Recruiting
First Posted : August 4, 2015
Last Update Posted : August 30, 2019
Single-arm, phase 2 study evaluating hypofractionated irradiation of breast and regional nodes in women with breast cancer. Patients will be grouped in 3 surgery-related treatment groups: 1) An intact breast following lumpectomy; 2) plans for loco regional external beam radiotherapy (EBRT) following mastectomy (with or without plans for reconstruction); and 3) plans for locoregional EBRT following mastectomy with reconstruction.
Patients will be assessed for lymphedema, arm function, breast or chestwall pain, other EBRT-related adverse events, and, for patients who had a lumpectomy or mastectomy with reconstruction, cosmetic outcome.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Node-positive Breast Cancer Breast Adenocarcinoma Invasive Breast Carcinoma Lobular Breast Carcinoma In Situ||Radiation: External Beam Radiation Therapy Other: Questionnaire Administration Other: Laboratory Biomarker Analysis||Not Applicable|
The HeNRIetta Trial is a phase 2 non-randomized clinical trial to evaluate the safety and effectiveness of hypofractionated RNI for women with resected node-positive breast cancer. The study hypothesis is that a 3-4 week hypofractionated course of post-lumpectomy or postmastectomy EBRT is as safe and effective as the biologically equivalent dose given in conventional fractionation over 5-7 weeks.
Eligible patients are women ≥ 40 years old who have undergone definitive surgery for node-positive breast cancer. Surgery may have been lumpectomy, mastectomy without reconstruction, or mastectomy with reconstruction. Nodal staging may have been performed by only sentinel lymph node (SLN) or by axillary lymph node (ALN) dissection. Patients may have received neoadjuvant or adjuvant chemotherapy at the discretion of the treating medical oncologist.
Breast and RNI will be administered to 42.56 Gy in 16 fractions. (RNI will exclude the axilla in patients who have had an ALN dissection.) A treatment boost of 4 to 6 fractions of 2.66 Gy/fraction to the lumpectomy cavity will be included for all patients who have had lumpectomy; a chestwall boost (4 to 6 fractions of 2.66 Gy/fraction) will be administered to patients who had mastectomy (with or without reconstruction) and close (< 2 mm) surgical margins. Total number of EBRT fractions will be 20 to 22 with a boost; 16 without a boost.
Bilateral measurements of arm circumference will be used to assess lymphedema by comparing the ipsilateral arm to the contralateral arm. Patients will also be assessed for and will complete questionnaires related to lymphedema, decreased arm function, breast and chestwall pain, other EBRT-related toxicities, cosmetic outcome, and local, regional, and distant breast cancer recurrence.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||145 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hypofractionated Regional Nodal Irradiation Phase 2 Clinical Trial for Women With Breast Cancer - HeNRIetta|
|Study Start Date :||August 4, 2015|
|Estimated Primary Completion Date :||April 30, 2023|
|Estimated Study Completion Date :||April 30, 2023|
Experimental: Treatment (EBRT)
External Beam Radiation Therapy (EBRT). Within 10 weeks after the last breast cancer surgery or the last dose of adjuvant chemotherapy, patients undergo hypofractionated RNI five days a week over 3-4 weeks.
The two subgroups are Cohort (A) sentinel lymph node (SLN) and Cohort (B) axillary lymph node (ALN) dissection. They are categorized depending on type of axillary surgery and treatment group. The type of axillary surgery is Sentinel lymph node (SLN) biopsy only vs axillary dissection with or without previous SLN biopsy. The treatment groups are lumpectomy vs mastectomy vs mastectomy/reconstruction.
Radiation: External Beam Radiation Therapy
Undergo hypofractionated RNI
Other: Questionnaire Administration
Other: Laboratory Biomarker Analysis
- To evaluate the cumulative incidence of lymphedema during the 3 years following completion of hypofractionated radiation treatment [ Time Frame: 3 years ]
Incidence of lymphedema defined as ≥ 10% increase in arm circumference over baseline circumference compared to the contralateral arm measured every 6 months from the time of initiation of hypofractionated irradiation of breast and regional nodes through 3 years following the completion of radiation therapy in 2 patient cohorts:
- Patients who have only had SLN biopsy for axillary staging
- Patients who have had ALN dissection for axillary staging
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): NCT02515110
|Contact: Pamela Loyall, RN||804-628-2667||MasseyRadOnc@vcu.edu|
|Contact: Douglas W Arthur, M.D.||firstname.lastname@example.org|
|United States, Virginia|
|Virginia Commonwealth University/Massey Cancer Center||Recruiting|
|Richmond, Virginia, United States, 23298|
|Contact: Pamela Loyall, RN 804-628-2667 MasseyRadOnc@vcu.edu|
|Contact: Douglas W. Arthur, M.D. 804-828-7232 email@example.com|
|Principal Investigator: Douglas W. Arthur, M.D.|
|VCU Community Memorial Healthcenter||Recruiting|
|South Hill, Virginia, United States, 23970|
|Principal Investigator: Douglas W. Arthur, M.D.|
|Sub-Investigator: Monica Morris, M.D.|
|Principal Investigator:||Douglas W Arthur, M.D.||Massey Cancer Center|