Ignite Creation Date:
2024-05-06 @ 1:24 AM
Last Modification Date:
2024-10-26 @ 11:03 AM
Study NCT ID:
NCT01803958
Status:
COMPLETED
Last Update Posted:
2019-03-27
First Post:
2013-02-27
Brief Title:
Breast Cancer With Low Risk Of Local Recurrence Partial and Accelerated Radiation With Three-Dimensional Conformal Radiotherapy 3DCRT Vs Standard Radiotherapy After Conserving Surgery Phase III Study
Sponsor:
Regione Emilia-Romagna
Organization:
Regione Emilia-Romagna
Study Overview
Official Title:
BREAST CANCER WITH LOW RISK OF LOCAL RECURRENCE PARTIAL AND ACCELERATED RADIATION WITH THREE-DIMENSIONAL CONFORMAL RADIOTHERAPY 3DCRT Versus STANDARD RADIOTHERAPY AFTER CONSERVING SURGERY PHASE III STUDY
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study was designed and developed in the Emilia Romania research and innovation program PRI ER The study does not have commercial sponsors and comes under the independent studies provided for by Ministerial Decree 17122005 The PRI ER program will guarantee a contribution to the study for the first three years of recruitment through the regional Innovation Fund to cover the costs of coordination and data management sustained by the Coordinating Center
Primary Objectives The study proposes to evaluate whether partial hypofractionated and accelerated irradiation of the sole surgical cavity in patients suffering from breast cancer with low risk of local recurrence and who undergo conservative surgery is not inferior to postoperative irradiation with conventional fractionation of the entire breast as regards local control incidence of ipsilateral recurrences as prime event
Secondary Objectives Comparison of the global survivals freedom from locoregional recurrences with exception for contralateral tumors and second tumors distant relapse-free except for local or regional relapses or in the contralateral breast in patients treated with conventional radiotherapy and accelerated partial radiation
To evaluate whether accelerated partial irradiation offers cosmetic results acute toxicity comparable with conventional irradiation
Possible connection with other national and international studies Similar studies which nonetheless evaluate different methods of partial irradiation are currently underway
Study Design Multicenter phase III controlled randomized unblinded study of non-inferiority
Number of cases Recruitment of 3302 patients is planned Target Population of the Study Women aged 49 ECOG 0-2 undergoing conservative breast surgery for invasive breast cancer pT 1-2 3 cm in diameter pN0-N1 M0 unifocal resection margins histologically negative ³ 2 mm at first intervention or after subsequent widening
Duration of the recruitment and of the subsequent follow-up A recruitment of 8 years is planned and a follow-up period of 5 years for an overall duration of the study of 13 years
Treatment
The patients will be randomized to receive one of the following treatments
Trial arm 385 Gy total in 10 fractions 385 Gy per fraction twice a day with an interval of at least 6 hours between the two fractions for five consecutive working days
Control arm 500 Gy in 25 fractions 2 Gy per fraction once a day for 5 days in the week
Endpoints Primary survival free of local ipsilateral recurrence as prime event Secondary global survival locoregional recurrence-free distant recurrence-free acute and late toxicity RTOG and cosmetic result
Evaluation and Follow-Up Program Controls are planned during the radiotherapy at the end of treatment at 6 weeks 3-6-12 months from the end of the radiotherapy and then once a year until the end of 5 years
Data Analysis Partial irradiation will be considered not inferior to the standard irradiation if the top extreme of the HR confidence interval at 95 to endpoint does not exceed the established value of 15 The study was sized in relation to the rate of local ipsilateral breast recurrences as prime event at 5 years and assuming that this rate in the standard treatment group is 4 accepting as maximum Hazard Ratio inferior to 15 and error a and b equal respectively to 005 and 010 and test at an endpoint
The survivals will be calculated using the Kaplan-Meier method The hazard ratio HR will be calculated using the Cox model and its confidence interval at 95 will be reported
Ethical Aspects and Informed Consent For participation in the study an informed consent is planned appropriately drawn up and submitted to the approval of the Ethics Committees
The clinical study will be carried out according to the ethical principles of the Helsinki Declaration the GCP guidelines the Italian laws and regulatory activities for carrying out clinical studies
Before formal commencement of the study its approvalsole opinion by the reference Ethics Committee of the proposing group is stipulated The individual investigators of the different participating institutions are directly responsible for the submission for approval of the protocol by their Ethics Committees
Primary Objectives The study proposes to evaluate whether partial hypofractionated and accelerated irradiation of the sole surgical cavity in patients suffering from breast cancer with low risk of local recurrence and who undergo conservative surgery is not inferior to postoperative irradiation with conventional fractionation of the entire breast as regards local control incidence of ipsilateral recurrences as prime event
Secondary Objectives Comparison of the global survivals freedom from locoregional recurrences with exception for contralateral tumors and second tumors distant relapse-free except for local or regional relapses or in the contralateral breast in patients treated with conventional radiotherapy and accelerated partial radiation
To evaluate whether accelerated partial irradiation offers cosmetic results acute toxicity comparable with conventional irradiation
Possible connection with other national and international studies Similar studies which nonetheless evaluate different methods of partial irradiation are currently underway
Study Design Multicenter phase III controlled randomized unblinded study of non-inferiority
Number of cases Recruitment of 3302 patients is planned Target Population of the Study Women aged 49 ECOG 0-2 undergoing conservative breast surgery for invasive breast cancer pT 1-2 3 cm in diameter pN0-N1 M0 unifocal resection margins histologically negative ³ 2 mm at first intervention or after subsequent widening
Duration of the recruitment and of the subsequent follow-up A recruitment of 8 years is planned and a follow-up period of 5 years for an overall duration of the study of 13 years
Treatment
The patients will be randomized to receive one of the following treatments
Trial arm 385 Gy total in 10 fractions 385 Gy per fraction twice a day with an interval of at least 6 hours between the two fractions for five consecutive working days
Control arm 500 Gy in 25 fractions 2 Gy per fraction once a day for 5 days in the week
Endpoints Primary survival free of local ipsilateral recurrence as prime event Secondary global survival locoregional recurrence-free distant recurrence-free acute and late toxicity RTOG and cosmetic result
Evaluation and Follow-Up Program Controls are planned during the radiotherapy at the end of treatment at 6 weeks 3-6-12 months from the end of the radiotherapy and then once a year until the end of 5 years
Data Analysis Partial irradiation will be considered not inferior to the standard irradiation if the top extreme of the HR confidence interval at 95 to endpoint does not exceed the established value of 15 The study was sized in relation to the rate of local ipsilateral breast recurrences as prime event at 5 years and assuming that this rate in the standard treatment group is 4 accepting as maximum Hazard Ratio inferior to 15 and error a and b equal respectively to 005 and 010 and test at an endpoint
The survivals will be calculated using the Kaplan-Meier method The hazard ratio HR will be calculated using the Cox model and its confidence interval at 95 will be reported
Ethical Aspects and Informed Consent For participation in the study an informed consent is planned appropriately drawn up and submitted to the approval of the Ethics Committees
The clinical study will be carried out according to the ethical principles of the Helsinki Declaration the GCP guidelines the Italian laws and regulatory activities for carrying out clinical studies
Before formal commencement of the study its approvalsole opinion by the reference Ethics Committee of the proposing group is stipulated The individual investigators of the different participating institutions are directly responsible for the submission for approval of the protocol by their Ethics Committees
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None