Proton Radiation Therapy for Invasive Breast Cancer Following Mastectomy
|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.|
|ClinicalTrials.gov Identifier: NCT01340495|
Recruitment Status : Active, not recruiting
First Posted : April 22, 2011
Results First Posted : April 20, 2018
Last Update Posted : August 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Invasive Breast Cancer||Radiation: Proton Radiation||Not Applicable|
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)|
|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|
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
- 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.
- 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 number of participants with any grade acute skin toxicities. Acute skin toxicity was assessed from the start of treatment until 90 days after the end of treatment. Skin toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).
- 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
- 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).
- To Evaluate Cosmetic Outcome and Patient Satisfaction With Cosmetic Outcome [ Time Frame: From the start of treatment until 5 years post treatment ]
- 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).
- The Number of Participants That Needed Unplanned Additional Surgery for Breast Reconstruction [ Time Frame: From the start of treatment until 5 years post treatment ]
- 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.
- 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.
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
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Shannon M MacDonald, M.D.||Massachusetts General Hospital|