Accelerated Partial Breast Irradiation With 3D-CRT and IMRT

Breast Cancer Clinical Trial

— APERT  

Official title:

Accelerated Partial Breast Irradiation After Breast Conserving Surgery for Low-risk Invasive Breast Cancer: 3D Conformal Radiotherapy (3D-CRT) and Intensity Modulated Radiotherapy (IMRT) - Prospective Phase II Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02003560
• Other study ID #: NIO-APERT_01
• Status: Active, not recruiting
• Phase: Phase 2
• First received: December 2, 2013
• Last updated: August 12, 2014
• Start date: December 2006
• Est. completion date: March 2024

Study information

• Verified date: August 2014
• Source: National Institute of Oncology, Hungary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: Scientific and Medical Research Council Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: March 2024
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Radiation Toxicity
• Side Effects

Intervention

Radiation:
• accelerated partial breast irradiation
9 x 4.1 Gy accelerated partial breast irradiation delivered by 3D-CRT or IMRT over 5 consecutive days, using twice-a-day fractionation.

Locations

Country	Name	City	State
Hungary	National Institute of Oncology	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Oncology, Hungary

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	quality of life	quality of life measured by the EORTC (European Organization for Research and Treatment of Cancer) QLQ-30 and BR-23 questionnaires	5 years	No
Primary	late radiation side-effect	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	5 years	Yes
Secondary	cosmetic results	cosmetic results at 5 years measured by the Harvard criteria	5 years	Yes
Secondary	local tumor control	Local tumor control defined as reappearance of the tumor in the ipsilateral breast	5 years	No
Secondary	regional tumor control	regional tumor control at 5 years	5 years	No
Secondary	overall survival	overall survival at 5 years	5 years	No
Secondary	disease free survival	disease free survival at 5 years	5 years	No
Secondary	cancer specific survival	cancer specific survival at 5 years	5 years	No