Ignite Creation Date:
2024-05-06 @ 3:12 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04550910
Status:
UNKNOWN
Last Update Posted:
2020-09-16
First Post:
2020-08-18
Brief Title:
RCT Comparing 2 Radiotherapy HypoFractionation Schedules In Breast Cancer Patients
Sponsor:
National Cancer Institute Egypt
Organization:
National Cancer Institute Egypt
Study Overview
Official Title:
Randomized Clinical Trial Comparing Two Adjuvant Radiotherapy Hypo Fractionation Schedules In The Treatment of Post Mastectomy Breast Cancer Patients
Status:
UNKNOWN
Status Verified Date:
2020-09
Last Known Status:
RECRUITING
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:
Breastcancer
Brief Summary:
This is a prospective randomized Phase III trial to assess efficiency of two post mastectomy hypofractionation schedules 40 Gy 15 fx 3 weeks 5 days per week VS 285 Gy delivered in 5 once-weekly fractions of 57 Gy each week as adjuvant radiotherapy in female patients with breast cancer after mastectomy
Detailed Description:
166 patients of breast cancer patients after mastectomy 83 patients in each arm will be randomize into 2 hypofractionation arms Arm A 40 Gy 15 fx 3 weeks 5 days per week Arm B 285 Gy delivered in 5 once-weekly fractions of 57 Gy each week
Simulation
Patient will be simulated on CT simulator using breast wedge with angle Serials will be taken every 2 mm from upper neck down to mid abdomen
Contouring
CTVcw CTVRNI will be contoured through RTOG guidelines PTV is added as 05 cm all around CTV Lungs Heart brachial plexus spinal cord esophageus and thyroid will be contoured as OAR wwwrtogorgCoreLabContouringAtlasesBreastCancerAtlasaspx
DDose Constraints
Arm A
PTV EVAL CW V90 90 - V105 5 - V107 3 Ipsilateral lung V20 less than 20-25 - V 8 less than 35- Contra lateral lung V4 less 10 Heart V16 less than 5 Lt sided V20 less than 5 Lt sided V16 is 0Rt sided V20 is 0 Rt sided Mean heart dose 320-400 cGy Contra lateral breast D max 240 cGy V 144 cGy less than 5 SCV V90 90 Thyroid Mean dose less than 35 Gy - V30 less than 50
Arm B
PTV EVAL CW V90 90 - V105 5 - V107 2
Ipsilateral lung V30less than 15 -20 - V15 less than 30-35 - V5 less than 50-55
Contra lateral lung V5 less than 5 Heart V25 less than 5 - V5 less than 30 - 35 Contra lateral breast V3 less than 5 SCV V90 90
Follow up
AWeekly follow up will be done during sessions then regular clinical exam every 3 months to assess
1 Acute and late toxicity regarding pain pulmonary toxicity dysphagia skin toxicity and lymphedemaAssessment will be done according to RTOG and CTCv5
2 Any local chest wall recurrence regional nodal recurrence
BAnnual Mammogram CAny another investigation once indicated
Simulation
Patient will be simulated on CT simulator using breast wedge with angle Serials will be taken every 2 mm from upper neck down to mid abdomen
Contouring
CTVcw CTVRNI will be contoured through RTOG guidelines PTV is added as 05 cm all around CTV Lungs Heart brachial plexus spinal cord esophageus and thyroid will be contoured as OAR wwwrtogorgCoreLabContouringAtlasesBreastCancerAtlasaspx
DDose Constraints
Arm A
PTV EVAL CW V90 90 - V105 5 - V107 3 Ipsilateral lung V20 less than 20-25 - V 8 less than 35- Contra lateral lung V4 less 10 Heart V16 less than 5 Lt sided V20 less than 5 Lt sided V16 is 0Rt sided V20 is 0 Rt sided Mean heart dose 320-400 cGy Contra lateral breast D max 240 cGy V 144 cGy less than 5 SCV V90 90 Thyroid Mean dose less than 35 Gy - V30 less than 50
Arm B
PTV EVAL CW V90 90 - V105 5 - V107 2
Ipsilateral lung V30less than 15 -20 - V15 less than 30-35 - V5 less than 50-55
Contra lateral lung V5 less than 5 Heart V25 less than 5 - V5 less than 30 - 35 Contra lateral breast V3 less than 5 SCV V90 90
Follow up
AWeekly follow up will be done during sessions then regular clinical exam every 3 months to assess
1 Acute and late toxicity regarding pain pulmonary toxicity dysphagia skin toxicity and lymphedemaAssessment will be done according to RTOG and CTCv5
2 Any local chest wall recurrence regional nodal recurrence
BAnnual Mammogram CAny another investigation once indicated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None