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Clinical Trials/NCT00418210
NCT00418210CompletedNot Applicable

A Multicentre Feasibility Study of Accelerated Partial Breast Irradiation Using Three-dimensional Conformal Radiation Therapy for Early Breast Cancer.

Trans Tasman Radiation Oncology Group14 sites in 2 countries48 target enrollmentStarted: August 1, 2007Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
48
Locations
14
Primary Endpoint
Feasibility rate of APBI using 3D conformal radiation therapy
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • Overall survival(A final analysis will occur when all patients have been followed up for 5 years.)
  • Radiation toxicity(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.)
  • Disease free survival(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.)
  • Cosmetic outcome(First analysis will occur 5 years after accrual of all patients (approximately 6 years after start of trial))
  • Quality of life(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.)
  • Time to ipsilateral breast recurrence(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.)

Investigators

Sponsor
Trans Tasman Radiation Oncology Group
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (14)

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