NCT05394194

Brief Summary

We aim to compare three different radiation delivery techniques, namely three-dimensional conformal radiation therapy (3D-CRT), intensity modulated radiotherapy (IMRT) and volumetric modulated radiation therapy (VMAT) in left-sided early breast cancer patients.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2022

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 27, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

July 20, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

2 years

First QC Date

May 24, 2022

Last Update Submit

May 24, 2022

Conditions

Keywords

computer assisted, radiotherapy

Outcome Measures

Primary Outcomes (2)

  • Comparison of coverage of planned target volume(PTV) among the three plans.

    PTV coverage in dose is compared among the three plans.

    1 year

  • Comparison of doses to organs at risk among the three plans.

    mean dose of the heart, lung volume receiving 20Gy, esophageal doses will be compared among the three plans

    1 year

Secondary Outcomes (1)

  • Comparison of target homogeneity among the three plans.

    1 year

Study Arms (3)

3DCRT group

In this plan, we will create plans using three dimensional conformal radiotherapy, evaluate organs at risk doses, dose homogeneity and planned target volume coverage. Then compare these parameters with the two other plans.

IMRT group

In this plan, we will create plans using intensity modulated radiotherapy (IMRT), evaluate organs at risk doses, dose homogeneity and planned target volume coverage. Then compare these parameters with the two other plans.

VMAT plan

In this plan, we will create plans using volumetric modulated radiotherapy (VMAT), evaluate organs at risk doses, dose homogeneity and planned target volume coverage. Then compare these parameters with the two other plans.

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

30 Female patients who will present to clinical Oncology department with early breast cancer, with pathological staging ≤ T2N0M0 and are operated by conservative breast surgery will be included in our current study.

You may qualify if:

  • left sided early breast cancer patients. Should have histopathological prove to have invasive breast cancer. Operated by breast conservative surgery. Have no associated comorbidities

You may not qualify if:

  • locally advanced breast cancer. Patients who have total mastectomy. Patients who had previous chest irradiation or known comorbidities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Alshaymaa Abdelghaffar, PhD

    Sohag University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alshaymaa Abdelghaffar, PhD

CONTACT

Emad Eldin Nabil Hassan, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Clinical Oncology

Study Record Dates

First Submitted

May 24, 2022

First Posted

May 27, 2022

Study Start

July 20, 2022

Primary Completion

July 1, 2024

Study Completion

August 1, 2025

Last Updated

May 27, 2022

Record last verified: 2022-05