Accelerated Partial Breast Irradiation for Early Breast Cancer

NCT00418210 | Completed DMC

• 2 other identifiers: TROG 06.02ACTRN12607000238471
• Study Type: interventional
• Target: 48
• Locations: 2 countries
• Sites: 7

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.

Conditions

Breast Cancer

Keywords

Accelerated Partial Breast Irradiation; Conformal Radiation Therapy; Feasibility; Early breast cancer

Outcome Measures

Primary Outcomes (1)

• Feasibility rate of APBI using 3D conformal radiation therapy

  First analysis will occur 6 months after accrual of all patients (approximately 1.5 years after start of trial)

Secondary Outcomes (6)

• 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.

• 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.

• 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.

Study Arms (1)

Accelerated partial breast irradiation

EXPERIMENTAL

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)

Interventions

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; 38.5 Gy in 3.85 Gy fractions bi-daily over 5 consecutive working days

Also known as: Radiation

Accelerated partial breast irradiation

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Trans Tasman Radiation Oncology Group: lead
• Peter MacCallum Cancer Centre, Australia: collaborator

Study Sites (7)

Calvary Mater Newcastle

Newcastle, New South Wales, 2298, Australia

Location

Royal North Shore Hospital

Sydney, New South Wales, 2069, Australia

Location

Princess Alexandra Hospital

Wooloongabba, Queensland, 4102, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 8006, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6001, Australia

Location

Auckland Hospital

Auckland, 1023, New Zealand

Location

Waikato Hospital

Hamilton, 3240, New Zealand

Location

Related Publications (3)

• 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. Australas Phys Eng Sci Med. 2009 Jun;32(2):98-104. doi: 10.1007/BF03178635.

  PMID: 19623861 BACKGROUND

• 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. J Med Imaging Radiat Oncol. 2009 Aug;53(4):412-8. doi: 10.1111/j.1754-9485.2009.02097.x.

  PMID: 19695049 RESULT

• Kron T, Willis D, Link E, Lehman M, Campbell G, O'Brien P, Chua B. Can we predict plan quality for external beam partial breast irradiation: results of a multicenter feasibility study (Trans Tasman Radiation Oncology Group Study 06.02). Int J Radiat Oncol Biol Phys. 2013 Nov 15;87(4):817-24. doi: 10.1016/j.ijrobp.2013.07.036. Epub 2013 Sep 21.

  PMID: 24064318 DERIVED

Related Links

• Click here for more information about this study on the TROG official website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy, Conformal; Radiation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Physical Phenomena

Study Officials

• Boon Chua

  Peter MacCallum Cancer Centre, Australia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2007
• First Posted: January 4, 2007
• Study Start: August 1, 2007
• Primary Completion: June 1, 2018
• Study Completion: August 20, 2018
• Last Updated: December 5, 2019

Record last verified: 2019-12

Locations

NZ (2); AU (5)