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Assessing the Cosmesis and Toxicity of Partial Breast Irradiation Using Proton Beam Irradiation

This study is currently recruiting participants.
Verified November 2017 by M.D. Anderson Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01245712
First Posted: November 22, 2010
Last Update Posted: November 24, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  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.

This is an investigational study. Proton radiation therapy is FDA approved and commercially available for breast cancer. Up to 200 women will take part in the study. All will be enrolled at MD Anderson.


Condition Intervention Phase
Breast Cancer Radiation: Accelerated Partial Breast Irradiation (APBI) Behavioral: Questionnaires Device: Proton Therapy System Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 ]
    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.


Secondary Outcome Measures:
  • Rate of CTCAE Grade 3+ Confluent Moist Desquamation [ Time Frame: Within 6 weeks of radiation therapy ]
    Rate of CTCAE grade 3+ confluent moist desquamation estimated within 6 weeks of radiation therapy with a 90% credible interval. If we observe CTCAE grade 3+ confluent moist desquamation in only 20 patients, then our 90% credible interval will be 7% to 13%.

  • Percent of Patients with Local Failure [ Time Frame: 10 years ]
    Percent of patients with local failure at 10 years estimated with an exact 95% confidence interval. If there is 1 patient with local failure at 10 years, and researchers have follow-up on all patients at 10 years, then the upper limit of the exact 95% confidence interval will be 2.8%. If researchers don't have 10 years of follow-up on all patients researchers will use the product-limit estimator of Kaplan and Meier (1958) to estimate the local failure rate at 10 years.


Estimated Enrollment: 200
Actual Study Start Date: November 15, 2010
Estimated Study Completion Date: November 1, 2021
Estimated Primary Completion Date: November 1, 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proton-Beam PBI Treatment
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).
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
Behavioral: Questionnaires
Questionnaires completed about breast changes at baseline, end of treatment, and at each follow up visit for 10 years.
Other Name: Surveys
Device: Proton Therapy System
Proton beam design will take into account day-to-day variability in treatment set-up and organ motion.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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:

  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
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): NCT01245712


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

Locations
United States, Texas
University of Texas 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 M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01245712     History of Changes
Other Study ID Numbers: 2009-0818
NCI-2011-01102 ( Registry Identifier: NCI CTRP )
First Submitted: November 19, 2010
First Posted: November 22, 2010
Last Update Posted: November 24, 2017
Last Verified: November 2017

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