Concurrent Boost Radiotherapy

This study has been completed.
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00981864
First received: September 21, 2009
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Breast Cancer
Radiation: Concurrent Boost RT
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: A Feasibility Study to Evaluate Intensity Modulated Radiation Therapy (IMRT) for Concomitant Boost Breast Radiotherapy (CBRT)

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate acute and late morbidity related to treatment [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • To identify factors and parameters associated with increased risk of treatment morbidity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • To evaluate local control rates [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • To develop treatment protocol outlining appropriate guidelines for planning and delivery [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 17
Study Start Date: November 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

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

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.
  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: NCT00981864

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

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00981864     History of Changes
Other Study ID Numbers: UHN REB 07-0594-C
Study First Received: September 21, 2009
Last Updated: December 19, 2012
Health Authority: Canada: Ethics Review Committee

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
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 25, 2014