Hypofractionation And Ultra-Hypofractionation In Adjuvant Radiotherapy For Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04434677
• Other study ID #: 0201263
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2019
• Est. completion date: June 28, 2021

Study information

• Verified date: March 2021
• Source: Alexandria University
• Contact: Amr Munir
• Phone: +201227241185
• Email: dr.amr.munir[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 28, 2021
• Est. primary completion date: June 28, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	ACOD	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Start of treatment till 3 months from end of treatment
Primary	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)	Before start treatment and from 6 months after finishing treatment every 6 months up to average 2 years
Primary	Rate of Ipsilateral local tumor recurrence	Local recurrence proved by image and biopsy	1 to 2 years
Primary	Compliance to treatment (number of interrupted days of radiation)	Treatment interruptions of planned cycles	Start treatment till end of treatment (2 weeks in arm one and 3 weeks in arm2)
Secondary	Overall survival	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