Accelerated Partial Breast Irradiation With 3D-CRT and IMRT (APERT)
|ClinicalTrials.gov Identifier: NCT02003560|
Recruitment Status : Active, not recruiting
First Posted : December 6, 2013
Last Update Posted : August 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Radiation Toxicity Side Effects||Radiation: accelerated partial breast irradiation||Phase 2|
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%.
- 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
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2006|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2024|
Experimental: Accelerated partial breast irradiation
Accelerated partial breast irradiation delivered by 3 dimensional conformal radiotherapy or intensity modulated radiotherapy
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.
- late radiation side-effect [ Time Frame: 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
- cosmetic results [ Time Frame: 5 years ]cosmetic results at 5 years measured by the Harvard criteria
- local tumor control [ Time Frame: 5 years ]Local tumor control defined as reappearance of the tumor in the ipsilateral breast
- regional tumor control [ Time Frame: 5 years ]regional tumor control at 5 years
- overall survival [ Time Frame: 5 years ]overall survival at 5 years
- disease free survival [ Time Frame: 5 years ]disease free survival at 5 years
- cancer specific survival [ Time Frame: 5 years ]cancer specific survival at 5 years
- quality of life [ Time Frame: 5 years ]quality of life measured by the EORTC (European Organization for Research and Treatment of Cancer) QLQ-30 and BR-23 questionnaires
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003560
|National Institute of Oncology|
|Budapest, Hungary, H-1122|
|Study Chair:||Csaba Polgár, MD, PhD, MSc||National Institute of Oncology|
|Principal Investigator:||Norbert Mészáros, MD||National Institute of Oncology|