Proton Radiation Therapy for Invasive Breast Cancer Following Mastectomy

NCT01340495 | Unknown Results DMC

• 1 other identifier: 10-205
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Invasive Breast Cancer

Keywords

Breast Cancer; Mastectomy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Grade 3 or Higher Radiation Pneumonitis or Any Grade 4 Adverse Event

  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.

  From the start of treatment until 3 months after the end of treatment, median duration of treatment of 6 weeks

Secondary Outcomes (8)

• The Number of Participants With Acute Skin Toxicities

  From the start of treatment until 3 months after the end of treatment

• Rate and Severity of Radiation Pneumonitis

  From the start of treatment until 3 months after the end of treatment and was not included in the analysis population.

• Summary of Late Skin Toxicity

  From 3 months after the end of treatment up to 5 years

• To Evaluate Cosmetic Outcome and Patient Satisfaction With Cosmetic Outcome

  From the start of treatment until 5 years post treatment

• Acute and Late Toxicity of Breast Reconstruction Following Proton Radiation

  From the start of treatment until 5 years post treatment

Study Arms (1)

Proton Radiation

EXPERIMENTAL

Radiation therapy with proton beam

Radiation: Proton Radiation

Interventions

Proton Radiation 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

Proton Radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

• Hassan MZO, Awadalla M, Tan TC, Scherrer-Crosbie M, Bakar RB, Drobni ZD, Zarif A, Gilman HK, Supraja S, Nikolaidou S, Zhang L, Zlotoff DA, Hickey SB, Patel SA, Januzzi JL, Keane F, Passeri JJ, Neilan TG, MacDonald SM, Jimenez RB. Serial Measurement of Global Longitudinal Strain Among Women With Breast Cancer Treated With Proton Radiation Therapy: A Prospective Trial for 70 Patients. Int J Radiat Oncol Biol Phys. 2023 Feb 1;115(2):398-406. doi: 10.1016/j.ijrobp.2022.08.036. Epub 2022 Aug 24.

  PMID: 36028065 DERIVED

• Jimenez RB, Hickey S, DePauw N, Yeap BY, Batin E, Gadd MA, Specht M, Isakoff SJ, Smith BL, Liao EC, Colwell AS, Ho A, Januzzi JL, Passeri J, Neilan TG, Taghian AG, Lu HM, MacDonald SM. Phase II Study of Proton Beam Radiation Therapy for Patients With Breast Cancer Requiring Regional Nodal Irradiation. J Clin Oncol. 2019 Oct 20;37(30):2778-2785. doi: 10.1200/JCO.18.02366. Epub 2019 Aug 26.

  PMID: 31449469 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Shannon MacDonald, MD
• Organization: Massachusetts General Hospital

SMACDONALD@mgh.harvard.edu

617-643-7250

Study Officials

• Shannon M MacDonald, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Radiation Oncologist

Study Record Dates

• First Submitted: April 20, 2011
• First Posted: April 22, 2011
• Study Start: June 1, 2011
• Primary Completion: April 1, 2017
• Study Completion: January 1, 2022
• Last Updated: January 5, 2021
• Results First Posted: April 20, 2018

Record last verified: 2021-01

Locations

US (1)