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A Trial of 15 Fraction vs 25 Fraction Pencil Beam Scanning Proton Radiotherapy After Mastectomy in Patients Requiring Regional Nodal Irradiation

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. Read our disclaimer for details. Identifier: NCT02783690
Recruitment Status : Active, not recruiting
First Posted : May 26, 2016
Last Update Posted : June 7, 2019
Information provided by (Responsible Party):
Robert Mutter, Mayo Clinic

Brief Summary:
This is a randomized controlled trial to determine the safety of 15 fraction vs 25 fraction pencil beam scanning proton radiotherapy after mastectomy in patients requiring regional nodal irradiation. Proton therapy is recognized as a standard option for the delivery of radiotherapy for breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Hypofractionation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MC1631: A Randomized Trial of 15 Fraction vs 25 Fraction Pencil Beam Scanning Proton Radiotherapy After Mastectomy in Patients Requiring Regional Nodal Irradiation
Actual Study Start Date : May 18, 2016
Actual Primary Completion Date : October 4, 2018
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Conventional Fractionation
50.0 Gy (RBE) in 25 daily fractions
Experimental: Hypofractionation
40 Gy (RBE) in 15 daily fractions
Radiation: Hypofractionation
40 Gy (RBE) in 15 daily fractions

Primary Outcome Measures :
  1. complication rate, defined as grade 3 or greater late adverse events and unplanned surgical intervention in patients who undergo mastectomy with reconstruction [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Acute Adverse Events [ Time Frame: 90 days post-RT ]
  2. Late Adverse Events and Reconstruction Failure [ Time Frame: 90 days post-RT and up to 5 years post-RT ]
  3. Quality of life [ Time Frame: up to 5 years post-RT ]
    measured by cosmesis evaluation and the Breast Cancer Treatment Outcome Scale (BCTOS)

  4. Cosmesis [ Time Frame: baseline, 2 years, and 5 years ]
    measured by reviewing digital photographs and the 4 point (excellent, good, fair, poor) adaptation of the Harvard Cosmesis Scale

  5. IBTR Incidence [ Time Frame: at 5 years post RT ]
  6. Distant Recurrence Incidence [ Time Frame: at 5 years post RT ]
  7. Disease-free Survival (DFS) [ Time Frame: at 5 years post RT ]
  8. Overall Survival (OS) [ Time Frame: at 5 years post RT ]

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:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria

  • Age ≥ 18 years
  • Histologic confirmation of breast cancer resected by mastectomy with or without immediate reconstruction and chest wall and regional nodal irradiation planned.
  • pStage T1-T4N0-N3M0 or ypStage T0-4N0-N3M0 Note: The axilla must be staged by sentinel node biopsy alone, sentinel node biopsy followed by axillary node dissection, or axillary lymph node dissection alone
  • ECOG Performance Status (PS) 0 to 2. (Appendix I).
  • Negative pregnancy test done ≤7 days prior to registration, for women of childbearing potential only.
  • Radiotherapy must begin within 12 weeks of last surgery (breast or axilla) or last chemotherapy.

Note: Breast implants and expanders allowed

  • Able to and provides IRB approved study specific written informed consent
  • Ability to complete questionnaire (s) by themselves or with assistance
  • 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)
  • Willing to provide tissue and blood samples for correlative research purposes.
  • Rochester and Arizona patients: Willing to sign consent onto the Mayo Clinic Radiotherapy Patient Outcomes Registry and Biobanking study, IRB number 15-000136
  • Rochester patients: Willing to sign consent onto Evaluation of cardiac function in patients undergoing proton beam or photon radiotherapy, IRB number 15-007443

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 or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception
  • Prior receipt of ipsilateral breast or chest wall radiation that would result in significant overlap of radiation therapy fields. Prior contralateral radiotherapy for breast cancer is allowed.
  • Positive margins after definitive surgery
  • 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
  • Inflammatory breast cancer
  • Recurrent Breast Cancer
  • Boosts to the chest wall after mastectomy. Nodal boosts are allowed.

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 identifier (NCT number): NCT02783690

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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
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Principal Investigator: Robert W Mutter Mayo Clinic

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Responsible Party: Robert Mutter, Assistant Professor of Radiation Oncology, Mayo Clinic Identifier: NCT02783690     History of Changes
Obsolete Identifiers: NCT03391453
Other Study ID Numbers: 15-006137
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019