Hypofractionation And Ultra-Hypofractionation In Adjuvant Radiotherapy For Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Hypofractionation
ultraHypofractionation
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring radiotherapy, hypofractionation, ultrahypofractionation, 5 fractions
Eligibility Criteria
Inclusion Criteria:
- Age ≥50 years old.
- Informed consent.
- Either breast conservative surgery or mastectomy.
- Invasive breast cancer with p T1-3, p N0-2.
- Non metastatic breast cancer proven by clinical examinations and imaging (X-ray chest and ultrasound or CT scan chest and abdomen).
Exclusion Criteria:
- Evidence of distant metastases.
- Prior irradiation.
- Inflammatory breast cancer.
- Tumor with T4 (skin nodules or fixed to chest wall or ulceration).
- Tumor with positive margins.
Sites / Locations
- ACODRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Hypofractionation
Ultrahypofractionation
Arm Description
Control arm:patients who will receive standard 40.05 Gray (2.67 Gy/ fx) over 15 fractions with or without boost over 3 weeks
Experimental arm: Patients who will receive 26 Gray (5.2 Gy/fx) over 5 fractions over 1.5 weeks
Outcomes
Primary Outcome Measures
Rate of Acute grade 2 or higher toxicity (NCI-CTCAE)
Each patient will be assessed weekly during radiotherapy and monthly for three months post radiotherapy to assess acute toxicity and will be documented according to Common Terminology Criteria for adverse events (CTCAE)
Rate of chronic Toxicity grade 2 or higher (NCI-CTCAE)
Each patient will be assessed before treatment and at 6 , 12 , 24 months for chronic toxicity Criteria for adverse events (CTCAE)
Rate of Ipsilateral local tumor recurrence
Local recurrence proved by image and biopsy
Compliance to treatment (number of interrupted days of radiation)
Treatment interruptions of planned cycles
Secondary Outcome Measures
Overall survival
the percentage of people in a study or treatment group who are alive two years after the start of treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04434677
Brief Title
Hypofractionation And Ultra-Hypofractionation In Adjuvant Radiotherapy For Breast Cancer
Official Title
Comparative Study Between Hypofractionation And Ultra-Hypofractionation In Adjuvant Radiotherapy For Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 28, 2019 (Actual)
Primary Completion Date
June 28, 2021 (Anticipated)
Study Completion Date
June 28, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Prospective randomized study comparing 5 fractions in alternative days to standard 15 fractions regarding effectiveness and feasibility during adjuvant treatment in breast caner patients aged above 50 years
Detailed Description
In Alexandria, the number of working linear machines are limited with overcrowded waiting list which lead to prolongation of overall treatment time and delay in starting radiotherapy. Providing the available data, Principle investigator is conducting this study in parallel with fast forward protocol to provide an alternative cost effective approach to patients.
The rationale behind hypofractionation depends mainly on the alpha beta ratio (α/β) and the overall treatment time. In Breast cancer the ratio is around 4 which is slightly lower than other tumors such as head and neck. The lower the ratio the higher the dose per fraction is needed to compensate slower proliferating tumors. Also, the overall treatment time could affect the local recurrence of breast cancer which is increased with long duration of treatment.
This study will include at least 100 patients with non metastatic histologically proved breast cancer who are indicated for adjuvant radiotherapy.
The patients will be randomized into two arms:
Control arm: will include 50 patients who will receive standard 40.05 Gray (2.67 Gy/fx) over 15 fractions with or without boost over 3 weeks biologically effective dose (BED) for early and late effect equal 50.74.Gy10 and 75.69 Gy3 respectively.
Experimental arm: will include 50 patients who will receive 26 Gray (5.2 Gy/fx) over 5 fractions over 1.5 weeks with BED for early and late effect equal 39.52 Gy10 and 71.07 Gy3 respectively
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
radiotherapy, hypofractionation, ultrahypofractionation, 5 fractions
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hypofractionation
Arm Type
Active Comparator
Arm Description
Control arm:patients who will receive standard 40.05 Gray (2.67 Gy/ fx) over 15 fractions with or without boost over 3 weeks
Arm Title
Ultrahypofractionation
Arm Type
Experimental
Arm Description
Experimental arm: Patients who will receive 26 Gray (5.2 Gy/fx) over 5 fractions over 1.5 weeks
Intervention Type
Radiation
Intervention Name(s)
Hypofractionation
Intervention Description
3D conformal Radiotherapy whole breast irradiation +- Supraclavicular fossa using Linear Machine (6-15 MV energy) 40.05 Gray (2.67 Gy/ fx) over 15 fractions with or without boost over 3 weeks
Intervention Type
Radiation
Intervention Name(s)
ultraHypofractionation
Intervention Description
3D conformal Radiotherapy whole breast irradiation +- Supraclavicular fossa using Linear Machine (6-15 MV energy) 26 Gray (5.2 Gy/fx) over 5 fractions over 1.5 weeks
Primary Outcome Measure Information:
Title
Rate of Acute grade 2 or higher toxicity (NCI-CTCAE)
Description
Each patient will be assessed weekly during radiotherapy and monthly for three months post radiotherapy to assess acute toxicity and will be documented according to Common Terminology Criteria for adverse events (CTCAE)
Time Frame
Start of treatment till 3 months from end of treatment
Title
Rate of chronic Toxicity grade 2 or higher (NCI-CTCAE)
Description
Each patient will be assessed before treatment and at 6 , 12 , 24 months for chronic toxicity Criteria for adverse events (CTCAE)
Time Frame
Before start treatment and from 6 months after finishing treatment every 6 months up to average 2 years
Title
Rate of Ipsilateral local tumor recurrence
Description
Local recurrence proved by image and biopsy
Time Frame
1 to 2 years
Title
Compliance to treatment (number of interrupted days of radiation)
Description
Treatment interruptions of planned cycles
Time Frame
Start treatment till end of treatment (2 weeks in arm one and 3 weeks in arm2)
Secondary Outcome Measure Information:
Title
Overall survival
Description
the percentage of people in a study or treatment group who are alive two years after the start of treatment.
Time Frame
From date of diagnosis up to average 2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥50 years old.
Informed consent.
Either breast conservative surgery or mastectomy.
Invasive breast cancer with p T1-3, p N0-2.
Non metastatic breast cancer proven by clinical examinations and imaging (X-ray chest and ultrasound or CT scan chest and abdomen).
Exclusion Criteria:
Evidence of distant metastases.
Prior irradiation.
Inflammatory breast cancer.
Tumor with T4 (skin nodules or fixed to chest wall or ulceration).
Tumor with positive margins.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amr Munir
Phone
+201227241185
Email
dr.amr.munir@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashraf M El-Enbaby, Prof
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
ACOD
City
Alexandria
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdelaziz Belal, PHD
Phone
+201223318257
Email
abdelazizbelal@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Hypofractionation And Ultra-Hypofractionation In Adjuvant Radiotherapy For Breast Cancer
We'll reach out to this number within 24 hrs