Stage II Breast Cancer Clinical Trial
— NOVEMBEROfficial title:
NOVEMBER (Novem- (9), BrEast Radiation), A Phase II Trial of a 9 Day Course of Whole Breast Radiotherapy for Early Stage Breast Cancer
Verified date | April 2024 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase II trial studies how well hypofractionated radiation therapy works in treating patients with stage 0-IIB breast cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.
Status | Active, not recruiting |
Enrollment | 102 |
Est. completion date | September 3, 2025 |
Est. primary completion date | August 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Histologically confirmed invasive carcinoma and/or ductal carcinoma in situ (DCIS) of the breast - Final pathologic Tis, T1-T3, all must be N0 and M0 status. - Negative inked histologic margins from lumpectomy, with the exception of a focus of positive margin at the pectoralis fascia - Radiation oncologist does not plan to treat regional lymph nodes beyond standard whole breast tangent fields - Lumpectomy with negative lymph node on surgical evaluation (Isolated tumor cells in lymph nodes will be permitted). Patients with invasive carcinoma = 70 yrs and with ER+ positive tumor = 2.0cm may enroll without surgical lymph node evaluation, per section 5.1. Patients with Ductal Carcinoma In Situ (DCIS) of the breast only may enroll without surgical lymph node evaluation. - Negative serum or urine beta-human chorionic gonadotropin (HCG) in women of child-bearing potential =< 7 days prior to registration - A female of childbearing potential is a sexually mature female who has not undergone a hysterectomy or bilateral oophorectomy and has not been naturally postmenopausal for at least 12 consecutive months - Women of child-bearing potential must agree to utilize a form of birth control or agree to undergo sexual abstinence during radiation therapy - Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1 - Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines Exclusion Criteria: - Prior radiation therapy to the chest, neck or axilla - Prior history of ipsilateral breast cancer (invasive disease or DCIS); lobular carcinoma in situ (LCIS) and benign breast disease is allowed - History of prior or concurrent contralateral invasive breast cancer; benign breast disease, LCIS or DCIS of contralateral breast is allowed - Active collagen vascular diseases, such as: systemic lupus erythematous, scleroderma, or dermatomyositis - Significant post lumpectomy complications requiring an unplanned re-operation or admission for intravenous (IV) antibiotics; re-operation for margins evaluation or nodal evaluation is acceptable - Co-existing medical conditions with life expectancy < 5 years - Other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix - Neoadjuvant chemotherapy or adjuvant chemotherapy delivered before radiation - Neuroendocrine carcinoma or sarcoma histology - Concurrent radiation sensitizing medications concurrent with radiation, per treatment physician |
Country | Name | City | State |
---|---|---|---|
United States | Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentages of Participants by EORTC Breast Cosmetic Rating Score at 24 Months Post-radiation Therapy | The EORTC (European Organisation for Research and Treatment of Cancer) Breast Cosmetic Rating system is a blinded digital photographic method that compares the radiated breast with the contralateral untreated side and evaluates: Size, shape, location of the areola/nipple, appearance of the surgical scar, skin pigmentation changes, presence of telangiectasia and a global cosmetic score based on all of the factors. Characteristics are graded on a four-point scale: 0, excellent or no difference; 1, good or small difference; 2, fair or moderate difference; and 3, poor or large difference. Images taken at the 24 month timepoint were assessed by 3 unbiased reviewers including a radiation oncologist, surgeon and nurse. The data is presented as the count of participants meeting the overall rating criteria as assessed by these reviewers. | Up to 24 months post radiation therapy (RT) | |
Secondary | Quality of Life as Measured by Breast-Q Questionnaire Scores at 6 Month Post-RT Timepoint | Assessed 4 subscales: satisfaction with breasts, psychosocial well-being, physical well-being, and sexual well-being.
Score from 0 (worst) to 100 (best). Higher scores reflect a better outcome. |
6 months post RT | |
Secondary | Quality of Life as Measured by Breast-Q Questionnaire Scores at 24 Month Post-RT Timepoint | Assessed 4 subscales: satisfaction with breasts, psychosocial well-being, physical well-being, and sexual well-being.
Score from 0 (worst) to 100 (best). Higher scores reflect a better outcome. |
24 months post RT | |
Secondary | Incidence of Acute and Late Radiation Complications Based on Common Terminology Criteria for Adverse Events (CTCAE) 4.0 Toxicity | The proportion of patients with acute or late radiation complications, will be estimated. Any event longer than 3 months will be considered a late effect. | Up to 5 years | |
Secondary | Local and Local Regional Recurrence Rate | We will report the incidence of recurrence | Up to 60 months | |
Secondary | Cost-effectiveness (CE) of Hypofractionated Radiation Versus Standard Fractionation | Will be explored using cost data and quality adjusted life years (QALYs) | Up to 3 years |
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