Randomized Study on Postmenopausal Women With Early Stage Breast Cancer: WBI Versus APBI

Sponsor

Istituto Clinico Humanitas (Other)

Overall Status

Terminated

CT.gov ID

NCT02375048

Collaborator

(none)

179

Enrollment

Location

Arms

36.4

Actual Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Selected patients with early stage breast cancer undergone conservative surgery were randomized in two arms: Hypofractionated Whole Breast Irradiation versus Accelerated Partial Breast Irradiation.

Condition or Disease	Intervention/Treatment	Phase
Cancer of Breast	Radiation: Hypofractionated WBI Radiation: Accelerated Partial Breast Irradiation	Phase 2

Detailed Description

Patients treated with Hypofractionated Whole Breast Irradiation (WBI) received SIB irradiation of the whole breast and surgical bed at two different dose levels. Dose prescription was 40.5 Gy to PTVWB and 48.0 Gy to PTVboost in 15 fractions over 3 weeks, with simultaneous integrated boost delivering 2.7 and 3.2Gy/fraction for each PTV respectively. Daily image guided radiotherapy (IGRT) were generated before each treatment session in each patient to verify the set-up.

Accelerated Partial Breast Irradiation (APBI) using external intensity -modulated radiotherapy (VMAT RA) was delivered at a dose of 30 Gy in five 6-Gy/day fractions over 10 days (every other day) with IGRT at each treatment.

Study Design

Study Type:

Interventional

Actual Enrollment :

179 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Randomized Study on Postmenopausal Women With Early Stage Breast Cancer: Adjuvant Hypofractionated Whole Breast Irradiation (WBI) Versus Accelerated Partial Breast Irradiation (APBI)

Actual Study Start Date :

Jan 19, 2015

Actual Primary Completion Date :

Feb 1, 2018

Actual Study Completion Date :

Feb 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Hypofractionated WBI Patients treated with hypofractionated Whole Breast Irradiation received Simultaneous Integrated Boost irradiation of the whole breast and surgical bed at two different dose levels using external intensity - modulated radiotherapy (VMAT RA).	Radiation: Hypofractionated WBI Dose prescription was 40.5 Gy to PTVWB and 48.0 Gy to PTVboost in 15 fractions over 3 weeks, with simultaneous integrated boost delivering 2.7 and 3.2Gy/fraction for each PTV respectively. Daily image guided radiotherapy (IGRT) were generated before each treatment session in each patient to verify the set-up.
Experimental: Accelerated Partial Breast Irradiation Patients treated with Accelerated Partial Breast Irradiation received the irradiation on surgical bed using external intensity - modulated radiotherapy (VMAT RA).	Radiation: Accelerated Partial Breast Irradiation APBI was delivered at a dose of 30 Gy in five 6-Gy/day fractions over 10 days (every other day) with IGRT at each treatment.

Arm

Intervention/Treatment

Active Comparator: Hypofractionated WBI

Patients treated with hypofractionated Whole Breast Irradiation received Simultaneous Integrated Boost irradiation of the whole breast and surgical bed at two different dose levels using external intensity - modulated radiotherapy (VMAT RA).

Radiation: Hypofractionated WBI

Dose prescription was 40.5 Gy to PTVWB and 48.0 Gy to PTVboost in 15 fractions over 3 weeks, with simultaneous integrated boost delivering 2.7 and 3.2Gy/fraction for each PTV respectively. Daily image guided radiotherapy (IGRT) were generated before each treatment session in each patient to verify the set-up.

Experimental: Accelerated Partial Breast Irradiation

Patients treated with Accelerated Partial Breast Irradiation received the irradiation on surgical bed using external intensity - modulated radiotherapy (VMAT RA).

Radiation: Accelerated Partial Breast Irradiation

APBI was delivered at a dose of 30 Gy in five 6-Gy/day fractions over 10 days (every other day) with IGRT at each treatment.

Outcome Measures

Primary Outcome Measures

Toxicity will be measured with CTCAE v.4.0 [ten years]
Cosmesis will be measured with Harvard scale [ten years]

Secondary Outcome Measures

Rate of Local Control [ten years]
Disease Free Survival [ten years]
Overall Survival [ten years]
Quality of Life Questionnaire [ten years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

55< Age <70
Tumor size ≤ 2 cm
pN0 (SN biopsy or ALND)
ER/PgR positive
Margins > 5 mm (either at initial surgery or at re-excision)
Clips placed in the surgical bed (minimum of 4 clips)
Unicentric only
No lymphovascular invasion
Any grade
No extensive intraductal component (>25%)
Written informed consent

Exclusion Criteria:

Prior thoracic radiation therapy
Oncoplastic surgery / No clips in the surgical bed
Multicentric cancer
Autoimmune disease, vasculitis, collagenopathy or scleroderma that may predispose to late sequelae

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istituto Clinico Humanitas	Rozzano	Milano	Italy	20089

Sponsors and Collaborators

Istituto Clinico Humanitas

Investigators

Principal Investigator: Marta Scorsetti, MD, Istituto Clinico Humanitas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michele Tedeschi, MD, Istituto Clinico Humanitas

ClinicalTrials.gov Identifier:

NCT02375048

Other Study ID Numbers:

1288

First Posted:

Mar 2, 2015

Last Update Posted:

Oct 24, 2018

Last Verified:

Oct 1, 2018

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Oct 24, 2018