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Hypofractionated Radiation Therapy in Treating Patients With Stage 0-IIB Breast Cancer (NOVEMBER)

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ClinicalTrials.gov Identifier: NCT03345420
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : September 5, 2019
Sponsor:
Information provided by (Responsible Party):
University of Utah

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ductal Breast Carcinoma In Situ Invasive Breast Carcinoma Stage 0 Breast Cancer Stage I Breast Cancer Stage IA Breast Cancer Stage IB Breast Cancer Stage II Breast Cancer Stage IIA Breast Cancer Stage IIB Breast Cancer Radiation: Hypofractionated Radiation Therapy Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate 24 month breast photographic cosmetic scores with 9 fraction radiation compared to standard hypofractionation.

SECONDARY OBJECTIVES:

I. To evaluate Breast-Q patient reported outcomes (PROs) compared to historical control in breast conservation.

II. To evaluate the incidence of acute and late radiation complications, based on Common Terminology Criteria for Adverse Events (CTCAE) 4.0 toxicity.

III. To evaluate the local and local regional recurrence rate. IV. To compare the direct and indirect patient costs for radiation therapy compared to historical controls as well as quality adjusted life years, utilizing the Breast-Q Patient Reported Outcomes (PROs) and the EQ-5D.

OUTLINE:

Within 12 weeks after breast conserving surgery, patients undergo hypofractionated radiation therapy for 9 fractions over 2 weeks.

After completion of study treatment, patients are followed up at 2-8 weeks, 6 months, and annually for 3 years.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NOVEMBER (Novem- (9), BrEast Radiation), A Phase II Trial of a 9 Day Course of Whole Breast Radiotherapy for Early Stage Breast Cancer
Actual Study Start Date : December 5, 2017
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Treatment (hypofractionated radiation therapy)
Within 12 weeks after breast conserving surgery, patients undergo hypofractionated radiation therapy for 9 fractions over 2 weeks.
Radiation: Hypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy
Other Names:
  • Hypofractionated Radiotherapy
  • hypofractionation




Primary Outcome Measures :
  1. Breast photographic cosmetic scores [ Time Frame: Up to 24 months post radiation therapy (RT) ]
    The scale used will be the modified EORTC Cosmetic Rating System of the treated compared to the untreated breast


Secondary Outcome Measures :
  1. Breast-Q patient reported outcomes (PROs) scores [ Time Frame: Scores at 6 months and 24 months post RT ]
    Will be using the Breast Q survey tool to assess patient-reported satisfaction with breast, well-being, and overall satisfaction. Scores at 6 months and 24 months post-radiation (relative to pre-RT) will be summarized and compared to prior published data, utilizing a two-sample t-test with a two-sided alternative.

  2. Incidence of acute and late radiation complications based on Common Terminology Criteria for Adverse Events (CTCAE) 4.0 toxicity [ Time Frame: Up to 5 years ]
    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.

  3. Local and local regional recurrence rate [ Time Frame: Up to 60 months ]
    We will report the incidence of recurrence

  4. Cost-effectiveness (CE) of hypofractionated radiation versus standard fractionation [ Time Frame: Up to 24 months post RT ]
    Will be explored using cost data and quality adjusted life years (QALYs)



Information from the National Library of Medicine

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

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

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): NCT03345420


Contacts
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Contact: Ashley Horstmeier 801-587-4655 Ashley.Horstmeier@hci.utah.edu

Locations
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United States, Utah
Huntsman Cancer Institute/University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Marissa Muse    801-587-9834    marissa.muse@hci.utah.edu   
Principal Investigator: Matthew M. Poppe         
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Matthew Poppe Huntsman Cancer Institute/ University of Utah

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Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT03345420     History of Changes
Other Study ID Numbers: HCI103976
NCI-2017-02018 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
HCI103976 ( Other Identifier: Huntsman Cancer Institute/University of Utah )
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Carcinoma
Breast Neoplasms
Carcinoma in Situ
Carcinoma, Ductal, Breast
Breast Carcinoma In Situ
Carcinoma, Intraductal, Noninfiltrating
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Carcinoma, Ductal
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary