Accelerated Partial Breast Irradiation With 3D-CRT and IMRT

Phase 2

• Conditions: Breast Cancer; Radiation Toxicity; Side Effects
• Interventions: Radiation: accelerated partial breast irradiation

• Registration Number: NCT02003560
• Lead Sponsor: National Institute of Oncology, Hungary

Brief Summary

The purpose of this study is to determine in a phase II clinical trial whether accelerated partial breast irradiation after breast conserving surgery using 3 dimensional external beam radiotherapy (3D-CRT) and intensity modulated radiotherapy (IMRT) for low-risk invasive breast cancer patients is safe without causing serious late radiation side-effects.

Detailed Description

It is a sequential phase II trial. Eligible patients after breast conserving surgery (BCS) are treated with accelerated partial breast irradiation (APBI) using three-dimensional conformal radiotherapy (3D-CRT) for the first 45 patients or intensity modulated radiotherapy (IMRT) for the second 45 patients.

Primary end-point of the study: late radiation side-effects at 5 years. Early stopping criteria: Not used as primary end-point is late side-effects. Interim analysis: Not planned Secondary end-points: cosmetic results, quality of life, local recurrence-free survival, regional recurrence free survival, distant metastasis free survival, relapse free survival, overall survival, cancer specific survival.

Null-hypothesis for primary end-point: The incidence of severe (\>G2) late radiation side-effects after APBI using 3D-CRT or IMRT will not exceed 10%.

Stratification:

* by treatment delivery: 3D-CRT - first 45 patients; IMRT - second 45 patients

* by bra capsize: Capsize A-B; C; and D-D+

Treatment intervention: 9 x 4.1 Gy APBI using 3D-CRT (first 45 patients) or IMRT (second 45 patients) delivered within 5 days, using twice-a-day fractionation.

Clinical target volume (CTV) and Planning target volume (PTV) definition:

CTV = excision cavity + 20 mm minus the actual pathological surgical margin in mm PTV = CTV + 5 mm in each direction

Follow-up:

* ECOG PS, physical examination (inspection and palpation), registration of side-effects (RTOG (Radiation Therapy Oncology Group) EORTC (European Organization for Research and Treatment of Cancer)) early and late radiation morbidity scoring scheme) and cosmetic results (using the Harvard scale) : 7-14 days after RT, than in every 3 months for 2 years, and every 6 months for 5 years.

* Mammography: at 6, 12, 18, 24 months, and annually thereafter

* Quality of life questionnaire (QLQ) (e.g. EORTC (European Organization for Research and Treatment of Cancer) QLQ-30 and Breast (BR)-23) before RT, at 7-14 days after RT, at 3, 6, and 12 months, and annually thereafter

* digital photography: before treatment, at 7-14 days after treatment, and yearly thereafter

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2013-12-02
• Study First Submitted QC: 2013-12-02
• Study First Posted: 2013-12-06
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-12
• Last Update Posted: 2014-08-13
• Primary Completion: 2019-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• previous breast conserving surgery within 12 weeks (in case of adjuvant chemotherapy within 28 days after completion of chemotherapy)
• patient age > 40 years
• ECOG performance status: 0-1
• life expectancy >5 years
• invasive ductal, papillary, mucinous, medullary or tubular carcinoma
• unifocal tumor
• pathological tumor size < or = 30 mm
• pathological negative axillary nodal status with axillary dissection or sentinel lymph node biopsy
• surgical clips in the tumor bed
• pathological surgical free margins of at least 2 mm
• written informed consent of patients

Exclusion Criteria

• Stage III-IV
• multifocal tumor
• extensive intraductal component (EIC)
• ductal or lobular carcinoma in situ (DCIS or LCIS)
• invasive lobular cancer (ILC)
• lymph-vascular invasion (LVI)
• contralateral breast cancer
• history of treatment for previous breast cancer
• lactation or breast feeding women
• Paget-disease of the nipple
• psychiatric disorder
• increased radiosensitivity (e.g. collagen vascular disease)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Accelerated partial breast irradiation	accelerated partial breast irradiation	Accelerated partial breast irradiation delivered by 3 dimensional conformal radiotherapy or intensity modulated radiotherapy

Primary Outcome Measures

Name	Time	Method
late radiation side-effect	5 years	Late radiation side-effects at 5 years scored by the RTOG (Radiation Therapy Oncology Group) EORTC (European Organization for Research and Treatment of Cancer) late radiation morbidity scoring scheme

Secondary Outcome Measures

Name	Time	Method
local tumor control	5 years	Local tumor control defined as reappearance of the tumor in the ipsilateral breast
overall survival	5 years	overall survival at 5 years
regional tumor control	5 years	regional tumor control at 5 years
cosmetic results	5 years	cosmetic results at 5 years measured by the Harvard criteria
cancer specific survival	5 years	cancer specific survival at 5 years
disease free survival	5 years	disease free survival at 5 years

Trial Locations

Locations (1)

National Institute of Oncology; 🇭🇺 Budapest, Hungary