Accelerated Partial Breast Irradiation With 3D-CRT and IMRT (APERT)
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|