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Proton Radiation Therapy for Invasive Breast Cancer Following Mastectomy

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ClinicalTrials.gov Identifier: NCT01340495
Recruitment Status : Active, not recruiting
First Posted : April 22, 2011
Results First Posted : April 20, 2018
Last Update Posted : April 20, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Shannon MacDonald, MD, Massachusetts General Hospital

Brief Summary:
In this study we are looking at a type of radiation called proton radiation which is known to spare surrounding tissue and organs from radiation. The proton radiation will be delivered using 3D conformal proton radiation or scanned beam/IMPT (Intensity Modulated Proton Radiation Treatment). Proton radiation delivers no dose beyond the region requiring treatment. This may reduce side effects that patients would normally experience with conventional radiation therapy or other means of delivering proton radiation therapy. In this study we are evaluating the effectiveness of using proton radiation delivered to reduce side effects association with radiation treatment.

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

Detailed Description:

Proton radiation will be delivered daily for approximately 5 1/2 weeks. Patients will be assessed weekly for any side effects they may be experiencing.

Patients will have follow-up visits 4 weeks after proton therapy ends, at 6 months, 12 months, and then every year for up to five years after treatment. Follow-up visits will include a physical examination, radiological imaging (if necessary), echocardiogram, and laboratory tests.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Proton Radiation Therapy for Invasive Breast Carcinoma Following Mastectomy
Study Start Date : June 2011
Actual Primary Completion Date : April 2017
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Proton Radiation
Radiation therapy with proton beam
Radiation: Proton Radiation
45-50.4 Gy(RBE) to the chest wall and 45-50.5 Gy(RBE) once daily, 5 days per week, for approximately 5 1/2 weeks



Primary Outcome Measures :
  1. Number of Participants With Grade 3 or Higher Radiation Pneumonitis or Any Grade 4 Adverse Event [ Time Frame: From the start of treatment until 3 months after the end of treatment, median duration of treatment of 6 weeks ]
    To determine the feasibility of using proton radiation for the treatment of invasive breast cancer following mastectomy based on the occurrence of grade 3 or > radiation pneumonitis or any grade 4 adverse event within 3 months after the completion of radiation treatment.


Secondary Outcome Measures :
  1. The Number of Participants With Acute Skin Toxicities [ Time Frame: From the start of treatment until 3 months after the end of treatment ]
    Summary of the acute skin toxicities experienced by participants. The number of participants effected is shown for each toxicity experienced. Skin toxicities were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).

  2. Rate and Severity of Radiation Pneumonitis [ Time Frame: From the start of treatment until 3 months after the end of treatment and was not included in the analysis population. ]

    The number of participants that experienced radiation pneumonitis within three months of the end of treatment. The participants that experienced radiation pneumonitis are grouped by grade. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).

    • Grade 1: Mild
    • Grade 2: Moderate
    • Grade 3: Severe
    • Grade 4: Life-Threatening
    • Grade 5: Fatal

  3. Summary of Late Skin Toxicity [ Time Frame: From 3 months after the end of treatment up to 5 years ]
    A summary of the late skin toxicities experienced by participants. The number of participants effected is shown for each toxicity experienced. Skin toxicities were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).

  4. To Evaluate Cosmetic Outcome and Patient Satisfaction With Cosmetic Outcome [ Time Frame: From the start of treatment until 5 years post treatment ]
  5. Acute and Late Toxicity of Breast Reconstruction Following Proton Radiation [ Time Frame: From the start of treatment until 5 years post treatment ]
    Combined summary of the acute (within 3 months of completing treatment) and late (3 months to 5 years after completion of treatment) toxicities experienced by participants thought to be related to breast reconstruction surgery following proton radiation treatment. Toxicities are assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).

  6. The Number of Participants That Needed Unplanned Additional Surgery for Breast Reconstruction [ Time Frame: From the start of treatment until 5 years post treatment ]
  7. The Number of Participants With Early Signs of Cardiac Effects From Radiation Therapy [ Time Frame: Baseline and then 4 and 8 weeks post treatment ]
    The number of participant that had early signs of cardiac effects from radiation therapy as assessed using a Strain Echo-cardiogram. The data from the Echo-cardiogram was evaluated for signs of negative impacts to cardiac function as determined by the treating physician. Parameters considered in the evaluation of the echo-cardiogram by the physician included myocardial velocity, strain, strain rate, and torsion. Blood-based cardiac bio-markers pro-BNP and ultra-sensitive troponin-I were also assessed. Either a clinically meaningful change in the strain echo-cardiogram parameters or clinically meaningful elevation of the bio-markers was sufficient to be considered to have early signs of cardiac effects.

  8. Progression Free Survival [ Time Frame: from the start of treatment until the time of disease progression, up to 5 years ]
    Progression-free survival is defined as the duration from the start of radiation to the date of objective disease progression or death due to any cause, whichever is earlier. Disease progression is defined as the appearance of one or more new lesions.



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

Inclusion Criteria:

  • Histologically confirmed invasive breast cancer confined to the breast and regional lymphatics
  • Completed mastectomy (complete not partial )breast surgery +/- reconstructive surgery
  • Life expectancy > 12 months

Exclusion Criteria:

  • Pregnant or breast-feeding
  • Prior therapeutic radiation > 200 cGy
  • History of a different malignancy unless disease-free for at least 5 years or diagnosed and treated cervical cancer in situ, or basal or squamous cell cancer of the skin
  • Prior investigation chemotherapy

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): NCT01340495


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Cancer Institute (NCI)
Investigators
Principal Investigator: Shannon M MacDonald, M.D. Massachusetts General Hospital
  Study Documents (Full-Text)

Documents provided by Shannon MacDonald, MD, Massachusetts General Hospital:

Responsible Party: Shannon MacDonald, MD, Attending Radiation Oncologist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01340495     History of Changes
Other Study ID Numbers: 10-205
First Posted: April 22, 2011    Key Record Dates
Results First Posted: April 20, 2018
Last Update Posted: April 20, 2018
Last Verified: March 2018

Keywords provided by Shannon MacDonald, MD, Massachusetts General Hospital:
Breast Cancer
Mastectomy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases