Hypofractionation And Ultra-Hypofractionation In Adjuvant Radiotherapy For Breast Cancer

March 30, 2021 updated by: Alexandria University

Comparative Study Between Hypofractionation And Ultra-Hypofractionation In Adjuvant Radiotherapy For Breast Cancer

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hypofractionation
Control arm:patients who will receive standard 40.05 Gray (2.67 Gy/ fx) over 15 fractions with or without boost over 3 weeks
Radiation: Hypofractionation
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
Experimental: Ultrahypofractionation
Experimental arm: Patients who will receive 26 Gray (5.2 Gy/fx) over 5 fractions over 1.5 weeks
Radiation: ultraHypofractionation
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Acute grade 2 or higher toxicity (NCI-CTCAE)
Time Frame: Start of treatment till 3 months from end of treatment
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)
Start of treatment till 3 months from end of treatment
Rate of chronic Toxicity grade 2 or higher (NCI-CTCAE)
Time Frame: Before start treatment and from 6 months after finishing treatment every 6 months up to average 2 years
Each patient will be assessed before treatment and at 6 , 12 , 24 months for chronic toxicity Criteria for adverse events (CTCAE)
Before start treatment and from 6 months after finishing treatment every 6 months up to average 2 years
Rate of Ipsilateral local tumor recurrence
Time Frame: 1 to 2 years
Local recurrence proved by image and biopsy
1 to 2 years
Compliance to treatment (number of interrupted days of radiation)
Time Frame: Start treatment till end of treatment (2 weeks in arm one and 3 weeks in arm2)
Treatment interruptions of planned cycles
Start treatment till end of treatment (2 weeks in arm one and 3 weeks in arm2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From date of diagnosis up to average 2 years
the percentage of people in a study or treatment group who are alive two years after the start of treatment.
From date of diagnosis up to average 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Principal Investigator: Ashraf M El-Enbaby, Prof, Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2019

Primary Completion (Anticipated)

June 28, 2021

Study Completion (Anticipated)

June 28, 2021

Study Registration Dates

First Submitted

May 29, 2020

First Submitted That Met QC Criteria

June 13, 2020

First Posted (Actual)

June 17, 2020

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 30, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0201263

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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