Hypofractionation And Ultra-Hypofractionation In Adjuvant Radiotherapy For Breast Cancer

NCT04434677 | Unknown DMC

• 1 other identifier: 0201263
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer

Keywords

radiotherapy; hypofractionation; ultrahypofractionation; 5 fractions

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Rate of Ipsilateral local tumor recurrence

  Local recurrence proved by image and biopsy

  1 to 2 years

• 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 Outcomes (1)

• Overall survival

  From date of diagnosis up to average 2 years

Study Arms (2)

Hypofractionation

ACTIVE COMPARATOR

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

Ultrahypofractionation

EXPERIMENTAL

Experimental arm: Patients who will receive 26 Gray (5.2 Gy/fx) over 5 fractions over 1.5 weeks

Radiation: ultraHypofractionation

Interventions

Hypofractionation RADIATION

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

Hypofractionation

ultraHypofractionation RADIATION

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

Ultrahypofractionation

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

ACOD

Alexandria, Egypt

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Study Officials

• Ashraf M El-Enbaby, Prof

  Alexandria University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amr Munir

CONTACT

+201227241185; dr.amr.munir@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 17, 2020
• Study Start: June 28, 2019
• Primary Completion: June 28, 2021
• Study Completion: June 28, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

EG (1)