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Partial Breast Irradiation Using Accelerated Intensity Modulated Radiotherapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Lori Pierce, University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00581529
First received: December 20, 2007
Last updated: July 24, 2012
Last verified: July 2012
History of Changes
  Purpose

This is a phase I- II feasibility study for delivering partial breast irradiation (PBI) in selected patients with early stage, lymph node negative, breast cancer after breast-conserving surgery using accelerated Intensity Modulated Radiotherapy (IMRT).


Condition Intervention Phase
Breast Cancer
 Radiation: IMRT
 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Partial Breast Irradiation Using Accelerated Intensity Modulated Radiotherapy in Early Stage Breast Cancer After Breast-Conserving Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • To determine the rate of local control of cancer in the treated breast at 2 years following breast-conserving surgery and partial breast radiotherapy using IMRT. [ Time Frame: 2 years after radiation ] [ Designated as safety issue: Yes ]
  • To determine the rate of acute adverse events, primarily ipsilateral breast skin toxicity during the course of the treatment, and late toxicity at follow-up visits over 5 years. [ Time Frame: 5 years after radiation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate dosimetric and volumetric differences between tmt plans for partial breast irradiation and other treatment planning methods for the target (partial breast) and organs at risk (e.g. heart, ipsilateral lung, contralateral breast)a subset of 20. [ Time Frame: not specific ] [ Designated as safety issue: No ]
  • To evaluate the impact of short term accelerated partial breast radiation therapy on the quality of life and to asses the cosmetic results. [ Time Frame: 2 years after radiation ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: November 2004
Estimated Study Completion Date: November 2014
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Only 1 tmt arm
Accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
 Radiation: IMRT
Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.

Detailed Description:

This is a non-randomized Phase I-II feasibility study of partial breast irradiation with accelerated IMRT technique. In this study, patients will be eligible if the estimated risk of breast cancer elsewhere in the breast (beyond the tumor bed) is low. The radiation treatment will be available to women who are older than 40 years, have a DCIS or T1, N0, M0, (AJCC classification, version 6.0), non-lobular infiltrating carcinoma treated with breast-conserving surgery.

Patients will undergo a pre-treatment planning free breathing CT with 5mm cuts in the treatment position, on a breast board, with both arms extended above their head that will be used to plan the traditional two field (tangent) plan. An Active Breathing Control (ABC) device will be used to minimize target motion due to breathing during a second CT scan. The lumpectomy cavity will be identified and delineated, and margins of approximately 1.5 cm in three dimensions will be used to allow for subclinical tumor extension and daily set-up error. The organs at risk (heart, lungs, contralateral breast) will be contoured on both CT scans. An inverse planning system and optimization tools will be employed in order to achieve the best IMRT plan (to minimize the dose to the heart, lungs and contralateral breast), that will be compared to the two field plan. If the IMRT plan is shown to be the optimal one, in terms of doses to organs at risk, then the patient will be enrolled in the protocol and will proceed with the treatment. Treatment will start approximately two weeks after the planning CT is obtained. All patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with unifocal histologically proven breast cancer, with or without calcifications in mammogram.
  • DCIS (Tis, Stage 0)
  • Non-lobular infiltrating carcinoma, maximum of 2 cm in diameter. (T1, Stage I)
  • The patient was operated on and the tumor was excised with lumpectomy
  • The tumor is reported with negative margins >3 mm, as per our hospital protocol.
  • For invasive carcinoma, axillary lymph nodes are negative by sentinel lymph node (SLN) mapping and biopsy or by formal axillary lymph node dissection.
  • The patient is over 40 years old with life expectancy of at least 5 years
  • Karnofsky status must be at least 70. See appendix I.
  • Pre- and post-menopausal women are eligible for entry.
  • The patient must be aware of the neoplastic nature of her disease and must be willing to consent after being informed of the potential benefits, side effects and risks of radiotherapy. Institutional Review Board approval of this protocol and a consent form is required.

Exclusion Criteria:

  • No concurrent or neoadjuvant chemotherapy is allowed. Patient is permitted to be treated with chemotherapy or hormone therapy only after completion of the radiation treatment.
  • Patients with diffuse calcifications, multifocal or multicentric disease, lymph-vascular invasion are excluded.
  • Patients cannot participate if there is extensive LCIS in specimen or extensive DCIS.
  • Patients are excluded if systemic disease is present or the patient has been irradiated to the ipsilateral breast or the chest wall.
  • Patients who are carriers of BRCA 1/2 mutations or at high risk for hereditary breast cancer due to strong family history (more than one pre-menopausal family member with breast cancer or any ovarian cancer) are excluded because of the increased potential for in-breast recurrence elsewhere in the breast in the absence of whole breast radiotherapy.
  • Patients with scleroderma, or systemic or discoid lupus are excluded due to the potential for significant radiotherapy associated toxicity.
  • Pregnant woman cannot participate in the study.
  • Patients who have serious medical problems which would limit survival to <5 years or a psychiatric condition which would prevent informed consent cannot participate.
  • Patients who are unable to lie on their back and raise their arms above their heads in the treatment planning position for radiotherapy are excluded.
  • Patients that have mammographically occult disease are excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00581529

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109-5010
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Principal Investigator: Lori J Pierce, MD University of Michigan
  More Information

No publications provided

Responsible Party: Lori Pierce, Principal Investigator, University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00581529     History of Changes
Other Study ID Numbers: UMCC 2004.020, IRB #2004-0459 & HUM 44980
Study First Received: December 20, 2007
Last Updated: July 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan Cancer Center:
breast

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

ClinicalTrials.gov processed this record on June 18, 2013