NCT06429995

Brief Summary

Motive: In order to improve the treatment technique, a comprehensive follow-up program is needed to obtain all relevant patient, treatment and toxicity data from breast cancer patients. Goal:to set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life. A standard database of patiënts receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment. To set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life. A standard database of patients receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
44mo left

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Progress84%
Jan 2008Jan 2030

Study Start

First participant enrolled

January 1, 2008

Completed
15.7 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2023

Completed
8 months until next milestone

First Posted

Study publicly available on registry

May 28, 2024

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

May 28, 2024

Status Verified

May 1, 2024

Enrollment Period

22 years

First QC Date

September 22, 2023

Last Update Submit

May 22, 2024

Conditions

Breast Cancer

Keywords

Acute toxicityLate toxicityPrediction models

Outcome Measures

Primary Outcomes (2)

  • Score of Acute toxicity

    Acute Toxicity is measured with Common Terminology Criteria for Adverse Events (CTCAE).

    Before start of radiation therapy and during radiation therapy and at 2 weeks after last day of radiation therapy.

  • Score of Late toxicity

    Late Toxicity is measured with Common Terminology Criteria for Adverse Events (CTCAE).

    At one and two years after last day of radiation therapy.

Secondary Outcomes (2)

  • Overall survival

    At 2 weeks after last day of radiation therapy and thereafter yearly, anticipated average 5-10 years.

  • Loco-regional tumor control

    At 2 weeks after last day of radiation therapy and thereafter yearly, anticipated average 5-10 years.

Other Outcomes (24)

  • Hemoglobin (Hb)

    Before start of radiation therapy

  • Hematocrit (Ht)

    Before start of radiation therapy

  • Leukocytes

    Before start of radiation therapy

  • +21 more other outcomes

Interventions

RadiotherapyRADIATION
Also known as: chemoradiation

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with breast cancer receiving radiotherapy

You may qualify if:

  • Patients with breast cancer Patients receiving a radiotherapy dose

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Location

Related Publications (2)

  • Stanton AL, Krishnan L, Collins CA. Form or function? Part 1. Subjective cosmetic and functional correlates of quality of life in women treated with breast-conserving surgical procedures and radiotherapy. Cancer. 2001 Jun 15;91(12):2273-81.

    PMID: 11413515BACKGROUND

  • Sneeuw KC, Aaronson NK, Yarnold JR, Broderick M, Regan J, Ross G, Goddard A. Cosmetic and functional outcomes of breast conserving treatment for early stage breast cancer. 1. Comparison of patients' ratings, observers' ratings, and objective assessments. Radiother Oncol. 1992 Nov;25(3):153-9. doi: 10.1016/0167-8140(92)90261-r.

    PMID: 1470691BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

RadiotherapyChemoradiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsCombined Modality TherapyDrug Therapy

Study Officials

  • Anne Crijns, MD, PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2023

First Posted

May 28, 2024

Study Start

January 1, 2008

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

May 28, 2024

Record last verified: 2024-05

Locations

NL(1)