Concurrent Boost Radiotherapy

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. Identifier: NCT00981864
Recruitment Status : Completed
First Posted : September 22, 2009
Last Update Posted : December 21, 2012
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
The primary aim of this study is to evaluate the feasibility of delivering 42.5 Gy to the breast with a concomitant 10 Gy boost to the tumour bed in 16 fractions for a total duration of 3.5 weeks using intensity modulated radiotherapy (IMRT). The primary end-point is the proportion of patients treated without major treatment deviation.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Concurrent Boost RT Phase 2

Detailed Description:

Rather than a sequential boost, we propose delivering a concomitant boost using intensity modulated radiotherapy (IMRT). IMRT is a sophisticated technique deliberately using multiple non-uniform beams, resulting in complex, conformal dose distributions. This technique offers several advantages. A concomitant IMRT boost potentially offers improved dose distributions by allowing more conformal doses around the boost volume and increased sparing of the remaining breast and adjacent organs at risk. Several studies have shown better target dose homogeneity resulting in less toxicity with adjuvant breast IMRT . One study found a significant reduction in the rates of moist desquamation with IMRT compared to wedged tangential fields (31% vs. 48%, P=0.0014).

Longer treatment duration increases the inconvenience and decreases patient compliance. Furthermore, this places extra financial and emotional hardship on the patient and her family, particularly if they must travel long distances between home and the treatment centre. Studies have found 10-30% of patients do not receive adjuvant radiotherapy after lumpectomy,placing these patients at higher risk for local recurrence and death from disease. Radiobiologically, a boost increases the risk of late normal tissue effects. In the EORTC study, they found significantly higher but limited rates of severe fibrosis at 10 years of 4.4% vs. 1.6% (p<0.0001) with the boost. No age effect was noted on the incidence of fibrosis. One study compared a shorter hypofractionated schedule of 42.5 Gy/16 fractions over 3.5 weeks with the standard schedule of 50 Gy/25 fractions over 5 weeks and observed comparable 5 year local recurrence rates and cosmetic outcomes.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility Study to Evaluate Intensity Modulated Radiation Therapy (IMRT) for Concomitant Boost Breast Radiotherapy (CBRT)
Study Start Date : November 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Concurrent Boost RT Radiation: Concurrent Boost RT
Patient will receive radiation to the tumour bed concurrently with whole breast radiation instead of receiving this treatment sequentially, that is, whole breast RT first then followed by RT directly to the tumour bed.

Primary Outcome Measures :
  1. To evaluate the feasibility of delivering 42.5 Gy to the breast with a concomitant 10 Gy boost to the tumour bed in 16 fractions without major treatment deviation. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. To evaluate acute and late morbidity related to treatment [ Time Frame: 2 years ]
  2. To identify factors and parameters associated with increased risk of treatment morbidity [ Time Frame: 2 years ]
  3. To evaluate local control rates [ Time Frame: 2 years ]
  4. To develop treatment protocol outlining appropriate guidelines for planning and delivery [ Time Frame: 2 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Female patient with a new histological diagnosis of invasive carcinoma OR ductal carcinoma-in-situ (DCIS) of the breast and no evidence of metastatic disease.
  2. Any of the following indications for boost radiotherapy to tumour bed:

    1. Age ≤ 60 years
    2. Positive or close resection margins (≤ 2 mm)
    3. Lymphovascular space invasion
    4. Extensive intraductal component (DCIS >25% of tumour volume)
  3. Three or fewer axillary nodes involved as determined either by:

    1. Sentinel node biopsy OR
    2. Axillary node dissection OR
    3. Clinical exam for patients with DCIS only or age greater than 70 years of age.
  4. Informed consent.

Exclusion Criteria:

  1. Age < 18 years.
  2. Seroma or surgical cavity on CT estimated to be > 30% of the breast volume.
  3. More than one primary tumour in different quadrants of the same breast.
  4. Previous irradiation to the ipsilateral breast that would preclude whole breast irradiation.
  5. Presence of an ipsilateral breast implant or pacemaker.
  6. Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus erythematosus (SLE), scleroderma) which would preclude definitive radiation treatment.
  7. For patients not treated with adjuvant chemotherapy: unable to commence radiation therapy within 12 weeks of the last surgical procedure on the breast.
  8. For patients treated with adjuvant chemotherapy: unable to commence within 8 weeks of the last dose of chemotherapy.
  9. Previous or concomitant malignancies except for patients with nonmelanoma skin cancer, contralateral non-invasive breast cancer or carcinoma in situ of any other site. In addition, patients with invasive cancers treated more than 5 years previously and without evidence of recurrence will be eligible.
  10. Currently pregnant or lactating.
  11. Psychiatric or addictive disorders which would preclude obtaining informed consent or adherence to protocol.
  12. Geographic inaccessibility for follow-up.
  13. Regional lymphatic irradiation planned.

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 identifier (NCT number): NCT00981864

Canada, Ontario
University Health Network, Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Principal Investigator: Fei-Fei Liu, MD University Health Network, Princess Margaret Hospital

Responsible Party: University Health Network, Toronto Identifier: NCT00981864     History of Changes
Other Study ID Numbers: UHN REB 07-0594-C
First Posted: September 22, 2009    Key Record Dates
Last Update Posted: December 21, 2012
Last Verified: December 2012

Keywords provided by University Health Network, Toronto:
radiation therapy in breast cancer
concurrent radiation
Breast cancer patients

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