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: August 7, 2013
Last verified: August 2013

January 2, 2007
August 7, 2013
August 2007
June 2018   (final data collection date for primary outcome measure)
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 ]
Feasibility rate of APBI using 3D conformal radiation therapy
Complete list of historical versions of study NCT00418210 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Radiation toxicity
  • Cosmetic outcome
  • Quality of life
  • Time to ipsilateral breast recurrence
  • Disease free survival
  • Overall survival
Not Provided
Not Provided
 
Accelerated Partial Breast Irradiation for Early Breast Cancer
A Multicentre Feasibility Study of Accelerated Partial Breast Irradiation Using Three-dimensional Conformal Radiation Therapy for Early Breast Cancer.

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.

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.
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
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
Experimental: Accelerated partial breast irradiation
Accelerated partial breast irradiation (APBI) to region of tumour bed using 3D conformal radiation therapy (3D CRT)
Intervention: Radiation: Accelerated partial breast irradiation (APBI) to region of tumour bed using 3D conformal radiation therapy (3D CRT)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
48
June 2019
June 2018   (final data collection date for primary outcome measure)

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
Female
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
New Zealand,   Australia
 
NCT00418210
TROG 06.02, ACTRN12607000238471
Yes
Trans-Tasman Radiation Oncology Group (TROG)
Trans-Tasman Radiation Oncology Group (TROG)
Peter MacCallum Cancer Centre, Australia
Study Chair: Boon Chua Peter MacCallum Cancer Centre, Australia
Trans-Tasman Radiation Oncology Group (TROG)
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP