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Hypofractionated Radiotherapy After Breast Conserving Surgery (MC1635)

This study is not yet open for participant recruitment.
Verified November 2017 by Carlos E. Vargas, Mayo Clinic
Sponsor:
ClinicalTrials.gov Identifier:
NCT03339934
First Posted: November 13, 2017
Last Update Posted: November 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Carlos E. Vargas, Mayo Clinic
  Purpose
The optimal dose and fractionation regimen for whole breast irradiation, whole breast and regional nodal irradiation, and postmastectomy radiotherapy remains unknown. The goal of this phase II randomized controlled trial is to determine whether the hypofractionated proton regimens proposed are non-inferior compared with standard fractionated proton radiotherapy and therefore worthy of further investigation.

Condition Intervention
Breast Cancer Radiation: Hypofractionation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Hypofractionated Radiotherapy to the Whole Breast Alone After Breast Conserving Surgery

Resource links provided by NLM:


Further study details as provided by Carlos E. Vargas, Mayo Clinic:

Primary Outcome Measures:
  • Complication Rate of 5 Fraction vs. 15 Fraction Whole Radiatherapy [ Time Frame: 24 months ]
    To determine the 24-month complication rate of 5 fraction whole radiotherapy +/- concurrent boost as compared to 15 fraction radiotherapy +/- sequential boost. Complications will be defined as one or more of the following events: 1) grade 3 or higher late adverse event (CTCAE v. 4.0) 2) deterioration of cosmesis from excellent/good to fair/poor or from fair to poor (Harvard cosmesis scale)


Estimated Enrollment: 82
Anticipated Study Start Date: November 27, 2017
Estimated Study Completion Date: July 8, 2023
Estimated Primary Completion Date: November 8, 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1: Conventional Hypofractionation
40 Gy (RBE) / Gy in 15 daily fractions with optional 10 Gy (RBE) / Gy in 4 fractions sequential boost to a total dose of 50 Gy in 19 fractions; or a concomitant boost to total dose of 48Gy in 15 daily fractions.(n=41)
Radiation: Hypofractionation
25Gy in 5tx to the whole breast
Experimental: Arm 2: 5 Fraction Hypofractionation
25 Gy (RBE) / Gy in 5 daily fractions with optional concurrent boost to a total dose of 30 Gy (RBE) / Gy in 5 fractions (n=41)
Radiation: Hypofractionation
25Gy in 5tx to the whole breast

Detailed Description:

Primary Objectives

To determine the 24-month complication rate of 25Gy in 5 fractions whole radiotherapy +/- concurrent boost as compared to 40Gy in 15 fraction radiotherapy +/- sequential boost. Complications will be defined as one or more of the following events: 1) grade 3 or higher late adverse event, 2) deterioration of cosmesis from excellent/good to fair/poor or from fair to poor.

ARM 1: Conventional hypofractionation 40 Gy (RBE) / Gy in 15 daily fractions with optional 10 Gy (RBE) / Gy in 4 fractions sequential boost to a total dose of 50 Gy in 19 fractions; or a concomitant boost to total dose of 48Gy in 15 daily fractions.(n=41)

ARM 2: 5 Fraction Hypofractionation 25 Gy (RBE) / Gy in 5 daily fractions with optional concurrent boost to a total dose of 30 Gy (RBE) / Gy in 5 fractions (n=41)

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Histological confirmation of breast cancer.
  • Pathologic Stage T0-T3N0-N1M0.
  • ECOG Performance Status (PS) 0 to 2. (Appendix I).
  • Able to and provides IRB approved study specific written informed consent.
  • Study entry must be within 12 weeks of last surgery (breast or axilla) or last chemotherapy (if applicable).
  • Able to complete all mandatory tests listed in section 4.0.
  • Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study).
  • Fair, good or excellent cosmesis, as determined by trained nurse assessment using the Harvard Cosmetic Scale.
  • Radiotherapy must begin within 12 weeks of the last breast cancer surgery or the last dose of adjuvant chemotherapy.
  • Breast conserving surgery and indications for whole breast radiotherapy.

Exclusion Criteria:

  • Medical contraindication to receipt of radiotherapy.
  • Severe active co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or providing informed consent.
  • Active systemic lupus or scleroderma.
  • Pregnancy.
  • Prior receipt of ipsilateral breast or chest wall radiation.
  • Positive margins on ink after definitive surgery either for DCIS or invasive cancer.
  • History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior study entry.
  • Recurrent breast cancer.
  • Indications for comprehensive regional nodal irradiation.
  Contacts and Locations
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): NCT03339934


Locations
United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Carlos E Vargas Mayo Clinic
  More Information

Responsible Party: Carlos E. Vargas, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03339934     History of Changes
Other Study ID Numbers: 16-008600
First Submitted: November 6, 2017
First Posted: November 13, 2017
Last Update Posted: November 24, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Carlos E. Vargas, Mayo Clinic:
Hypofractionation
Proton therapy
3D conformal radiation
Randomized
Phase II