Adjuvant Whole Breast Irradiation in Five Fractions Versus Fifteen Fractions in Early Breast Cancer

NCT05112341 | Unknown

• 1 other identifier: soh-Med-21-10-17
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

the study aiming for compairing results of hypofractionaton radiotherapy treatment in patient with early breast cancer between two arms the first arm recieving five fractions and the other arm recieving fifteen fraction

Conditions

Study on Breast Cancer Patients

Outcome Measures

Primary Outcomes (3)

• 1-disease free survival

  the time free from disease

  2 years

• 2- overall survival

  the period time from treatment till death

  2 years

• 3- toxicity from treatment

  side effects from treatment

  2 years

Study Arms (2)

group 1 standared hypofractonation

Radiation: radiation therapy

group 2 fast forward group

Radiation: radiation therapy

Interventions

radiation therapy RADIATION

the patient first is simulated then delineation is done

group 1 standared hypofractonation; group 2 fast forward group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

the study includes patients with early breast cancer recieving adjuvant radiotherapy in hypofractionation pattern the first arm recieving 15 fraction and the seconed arm recieving five fractions

You may qualify if:

• age group ( 18-80) years
• breast conservation surgery
• Stages (pT1-3, pN0-1, M0) breast cancer.
• Any histological type of invasive breast cancer.
• All grades of breast cancer (I,II,III)

You may not qualify if:

• Stage (III or IV) breast cancer.
• Metastatic breast cancer (MBC)
• Recurrent breast cancer.
• Patients' co-morbidities that contraindicate radiotherapy

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

Related Publications (3)

• Ibrahim AS, Khaled HM, Mikhail NN, Baraka H, Kamel H. Cancer incidence in egypt: results of the national population-based cancer registry program. J Cancer Epidemiol. 2014;2014:437971. doi: 10.1155/2014/437971. Epub 2014 Sep 21.

  PMID: 25328522 BACKGROUND

• Mascaro A, Farina M, Gigli R, Vitelli CE, Fortunato L. Recent advances in the surgical care of breast cancer patients. World J Surg Oncol. 2010 Jan 20;8:5. doi: 10.1186/1477-7819-8-5.

  PMID: 20089167 BACKGROUND

• Coates AS, Winer EP, Goldhirsch A, Gelber RD, Gnant M, Piccart-Gebhart M, Thurlimann B, Senn HJ; Panel Members. Tailoring therapies--improving the management of early breast cancer: St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2015. Ann Oncol. 2015 Aug;26(8):1533-46. doi: 10.1093/annonc/mdv221. Epub 2015 May 4.

  PMID: 25939896 BACKGROUND

MeSH Terms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

heba a abdelal, assistant lecturer

CONTACT

01062162612; hebaelsagheer@yahoo.com

mohamed s gaber, professor

CONTACT

01025876769

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer of oncolgy. sohag university hospital

Study Record Dates

• First Submitted: October 24, 2021
• First Posted: November 8, 2021
• Study Start: June 1, 2021
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: November 8, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: 2 years

Locations

EG (1)