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

NCT ID: NCT05112341

Last Updated: 2021-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2023-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Study on Breast Cancer Patients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

group 1 standared hypofractonation

radiation therapy

Intervention Type RADIATION

the patient first is simulated then delineation is done

group 2 fast forward group

radiation therapy

Intervention Type RADIATION

the patient first is simulated then delineation is done

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

radiation therapy

the patient first is simulated then delineation is done

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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)

Exclusion Criteria

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

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sohag University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Heba Ali Elsagheer

assistant lecturer of oncolgy. sohag university hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sohag University Hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

heba a abdelal, assistant lecturer

Role: CONTACT

Phone: 01062162612

Email: [email protected]

mohamed s gaber, professor

Role: CONTACT

Phone: 01025876769

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Osama R ElSherif, professor

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 25328522 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20089167 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25939896 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

soh-Med-21-10-17

Identifier Type: -

Identifier Source: org_study_id