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Accelerated Partial Breast Irradiation for Early Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Peter MacCallum Cancer Centre, Australia
Information provided by (Responsible Party):
Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier:
NCT00418210
First received: January 2, 2007
Last updated: November 13, 2014
Last verified: November 2014
  Purpose

Hypothesis:

In selected women with node-negative invasive breast cancer treated with breast conserving surgery, postoperative accelerated partial breast irradiation (APBI) limited to the region of the tumour bed delivered by 3-dimensional conformal radiation therapy (3D CRT) is technically feasible and reproducible with acceptable treatment toxicity, cosmetic outcome, and local control rate in a multicentre trial.


Condition Intervention
Breast Cancer
Radiation: Accelerated partial breast irradiation (APBI) to region of tumour bed using 3D conformal radiation therapy (3D CRT)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicentre Feasibility Study of Accelerated Partial Breast Irradiation Using Three-dimensional Conformal Radiation Therapy for Early Breast Cancer.

Resource links provided by NLM:


Further study details as provided by Trans-Tasman Radiation Oncology Group (TROG):

Primary Outcome Measures:
  • Feasibility rate of APBI using 3D conformal radiation therapy [ Time Frame: First analysis will occur 6 months after accrual of all patients (approximately 1.5 years after start of trial) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Radiation toxicity [ Time Frame: First analysis will occur 6 months after accrual of all patients (approximately 1.5 years after start of trial). A final analysis will occur when all patients have been followed up for 5 years. ] [ Designated as safety issue: Yes ]
  • Cosmetic outcome [ Time Frame: First analysis will occur 5 years after accrual of all patients (approximately 6 years after start of trial) ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: First analysis will occur 5 years after accrual of all patients (approximately 6 years after start of trial). A final analysis will occur when all patients have been followed up for 5 years. ] [ Designated as safety issue: No ]
  • Time to ipsilateral breast recurrence [ Time Frame: First analysis will occur 5 years after accrual of all patients (approximately 6 years after start of trial). A final analysis will occur when all patients have been followed up for 5 years. ] [ Designated as safety issue: No ]
  • Disease free survival [ Time Frame: First analysis will occur 5 years after accrual of all patients (approximately 6 years after start of trial). A final analysis will occur when all patients have been followed up for 5 years. ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: A final analysis will occur when all patients have been followed up for 5 years. ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: August 2007
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Accelerated partial breast irradiation
Accelerated partial breast irradiation (APBI) to region of tumour bed using 3D conformal radiation therapy (3D CRT)
Radiation: Accelerated partial breast irradiation (APBI) to region of tumour bed using 3D conformal radiation therapy (3D CRT)
Accelerated partial breast irradiation (APBI) to region of tumour bed using 3D conformal radiation therapy (3D CRT; 38.5 Gy in 3.85 Gy fractions bi-daily over 5 consecutive working days
Other Name: Radiation

Detailed Description:

This is a TROG multicentre feasibility study of APBI using 3D CRT in selected women with node-negative breast cancer treated by breast conserving surgery with negative margins.

This is a one-arm feasibility study in which the primary endpoint is the feasibility rate for APBI using 3D CRT. This is defined as the proportion of eligible patients treated without a major protocol deviation. Secondary endpoints include radiation toxicity, cosmetic outcome, quality of life, time to ipsilateral breast recurrence, disease-free survival, and overall survival.

Primary objectives: To evaluate the technical feasibility and reproducibility of APBI limited to the region of the tumour bed using 3D CRT following breast conserving surgery.

Secondary objectives:

  • To assess the acute and long term toxicity of APBI using 3D CRT.
  • To examine the cosmetic outcome of women with breast cancer treated by breast conserving surgery and APBI using 3D CRT.
  • To determine the time to ipsilateral breast recurrence, disease free survival and overall survival of women with node-negative breast cancer completely resected by breast conserving surgery followed by APBI using 3D CRT.
  • To assess the quality of life of women with node-negative breast cancer treated by breast conserving surgery and APBI using 3D CRT.
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients must fulfill all of the following criteria for admission to study:

  • Women aged >= 50 years.
  • Histologically confirmed diagnosis of invasive breast carcinoma of non-lobular histology.
  • Bilateral mammograms performed within 6 months prior to registration.
  • Treated with breast conserving surgery (primary excision or re-excision) with negative radial resection margins of >= 2 mm* for both the invasive and if present, associated intraductal tumour.

    *Patients with superficial or deep resection margin of < 2 mm are eligible if surgery has removed all of the intervening breast tissue from the subcutaneous tissue to the pectoralis fascia.

  • Unifocal tumour measuring ≤ 20 mm in maximum microscopic dimension.
  • Negative nodal status determined by sentinel node biopsy, axillary dissection, or for women > 70 years of age, clinical examination.
  • No evidence of distant metastasis.
  • Assessed by surgeon and radiation oncologist to be suitable for breast conserving therapy.
  • Ability to tolerate protocol therapy.
  • Protocol therapy must commence no later than 12 weeks from the last surgical procedure or 8 weeks from the last dose of chemotherapy.
  • Availability for long-term follow-up.
  • Women of child-bearing potential must use adequate contraception during RT.
  • Written informed consent.

Exclusion Criteria:

Patients who fulfill any of the following criteria are not eligible for admission to study:

  • Multifocal or multicentric tumours.
  • Clinical or pathologic evidence of any of the following tumour features: extension to chest wall (excluding pectoralis muscle); oedema (including peau d'orange) or ulceration of skin; satellite skin nodules confined to the same breast; and inflammatory carcinoma.
  • Presence of extensive intraductal component (ductal carcinoma in situ occupying > 25% of the primary invasive tumour and present adjacent to the primary tumour).
  • Node-positive breast cancer determined by sentinel node biopsy, axillary dissection, or in women > 70 years of age, clinical examination.
  • Inability to localise surgical cavity on CT scans with no evidence of a surgical cavity, seroma or surgical clips delineating the tumour bed.
  • Treatment target volume estimated to occupy > 25% of the ipsilateral whole breast volume.
  • Synchronous or metachronous bilateral invasive or intraductal breast cancer.
  • Locally recurrent breast cancer.
  • Ipsilateral breast implant.
  • Serious non-malignant disease that precludes definitive surgical or radiation treatment (e.g. scleroderma, systemic lupus erythematosus, cardiovascular/pulmonary/renal disease).
  • Previous or concomitant malignancies except non-melanoma skin cancer, carcinoma in situ of the cervix, and invasive carcinoma of the colon, thyroid, cervix, or endometrium treated five years prior to study entry.
  • Women who are pregnant or lactating.
  • Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol
  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: NCT00418210

Locations
Australia, New South Wales
Calvary Mater Newcastle
Newcastle, New South Wales, Australia, 2298
Royal North Shore Hospital
Sydney, New South Wales, Australia, 2069
Australia, Queensland
Princess Alexandra Hospital
Wooloongabba, Queensland, Australia, 4102
Australia, Victoria
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 8006
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6001
New Zealand
Auckland Hospital
Auckland, New Zealand, 1023
Waikato Hospital
Hamilton, New Zealand, 3240
Sponsors and Collaborators
Trans-Tasman Radiation Oncology Group (TROG)
Peter MacCallum Cancer Centre, Australia
Investigators
Study Chair: Boon Chua Peter MacCallum Cancer Centre, Australia
  More Information

Additional Information:
Publications:
Kron T, Willis D, Bignell F, Martland J, Donnell S, May S, Chua BH. Centre credentialing for Trans Tasman Radiation Oncology Group trial 06.02: multicentre feasibility study of accelerated partial breast irradiation. Journal of Medical Imaging and Radiation Oncology. 2009, 53, 4, 412 - 418.
Kron T, Willis D, Miller J, Hubbard P, Oliver M, Chua B. A spreadsheet to determine the volume ratio for target and breast in partial breast irradiation. Australian Physical & Engineering Sciences in Medicine 32:2 (2009) 98-104

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier: NCT00418210     History of Changes
Other Study ID Numbers: TROG 06.02, ACTRN12607000238471
Study First Received: January 2, 2007
Last Updated: November 13, 2014
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Trans-Tasman Radiation Oncology Group (TROG):
Accelerated Partial Breast Irradiation
Conformal Radiation Therapy
Feasibility
Early breast cancer

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

ClinicalTrials.gov processed this record on November 25, 2014