Partial Breast Proton Beam Irradiation

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01245712
First received: November 19, 2010
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

The goal of this clinical research study is to find out if receiving a 1-week course of partial breast irradiation (PBI) using proton therapy will cause fewer and/or less severe side effects (such as changes to the appearance of the breast) than a longer course of radiation treatment.


Condition Intervention Phase
Breast Cancer
Radiation: Accelerated Partial Breast Irradiation (APBI)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessing the Cosmesis and Toxicity of Partial Breast Irradiation Using Proton Beam Irradiation

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Patient-Reported Cosmesis Score [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Patient-reported cosmesis score on the Breast Cancer Treatment Outcomes Scale (BCTOS) at 1 year. Cosmesis scores range from 1 (excellent) to 4 (poor), and scores of 3 (fair) or more indicate adverse cosmetic outcomes.


Estimated Enrollment: 100
Study Start Date: November 2010
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proton-Beam PBI Treatment
Two 3.4 Gy fractions administered per day, separated by at least 6 hours for a total of 34 Gy delivered in 10 fractions (5 - 6 days in a row).
Radiation: Accelerated Partial Breast Irradiation (APBI)
Two 3.4 Gy fractions administered per day, separated by at least 6 hours for a total of 34 Gy delivered in 10 fractions (5 - 6 days in a row).
Other Names:
  • Radiation therapy
  • Proton radiation
  • XRT
  • Accelerated partial breast irradiation
  • APBI

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines.
  2. Patients must be >/= 18 years old. (Adenocarcinoma of the breast is not seen in children)
  3. The patient must have stage 0, I, or II breast cancer. If stage II, the tumor size must be 3 cm or less.
  4. On histological examination, the tumor must be DCIS or invasive adenocarcinoma of the breast.
  5. Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (DCIS and invasive). Reexcision of surgical margins is permitted.
  6. Gross disease must be unifocal with pathologic (invasive and/or DCIS) tumor size 3 cm or less. (Patients with microscopic multifocality are eligible as long as total pathologic tumor size is 3 cm or less.)
  7. Patients with invasive breast cancer are required to have axillary staging which can include sentinel node biopsy alone (if sentinel node is negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes (if sentinel node is positive), or axillary dissection alone (with a minimum of 6 axillary nodes). Axillary staging is not required for patients with DCIS.
  8. The target lumpectomy cavity must be clearly delineated and the target lumpectomy cavity/whole breast reference volume must be less than or equal to 30% based on the postoperative/pre-enrollment CT scan.
  9. Patients are eligible if, based on the postoperative CT scan, PBI is judged to be technically deliverable.
  10. Patients with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior to enrollment and are deemed by their physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.

Exclusion Criteria:

  1. Men are not eligible for this study.
  2. T2 (> 3.0 cm), T3, stage III, or stage IV breast cancer.
  3. More than 3 histologically positive axillary nodes.
  4. Axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension.
  5. Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes at time of enrollment unless there is histologic confirmation that these nodes are negative for tumor.
  6. Suspicious microcalcifications, or densities (in the ipsilateral or contralateral breast as documented on mammogram or breast ultrasound) unless biopsied and found to be benign.
  7. Non-epithelial breast malignancies such as sarcoma or lymphoma.
  8. Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters.
  9. Paget's disease of the nipple.
  10. Synchronous bilateral invasive or non-invasive breast cancer.
  11. Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by reexcision, the patient is eligible.)
  12. Clear delineation of the extent of the target lumpectomy cavity not possible.
  13. Treatment plan that includes regional nodal irradiation.
  14. Prior radiation to the index breast.
  15. Documented diagnosis of collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
  16. Pregnancy or lactation at enrollment.
  17. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01245712

Contacts
Contact: Eric A. Strom, MD, BS 713-563-2300

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Eric A. Strom, MD, BS         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Eric A. Strom, MD, BS UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01245712     History of Changes
Other Study ID Numbers: 2009-0818, NCI-2011-01102
Study First Received: November 19, 2010
Last Updated: February 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Adenocarcinoma of the breast
Lumpectomy
Stage 0 breast cancer
Stage I breast cancer
Stage II breast cancer
Accelerated partial breast irradiation
APBI

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

ClinicalTrials.gov processed this record on July 24, 2014