NCT05937958

Brief Summary

The goal of this observational study is to explore the effectiveness and side effects of a high dose daily adapted SBRT (stereotactic body radiotherapy) boost delivered with MRLinac in patients with gynaecological cancers that cannot receive a brachytherapy boost to the primary tumour for different reasons (medical conditions, tumour extensions, etc). Current alternative for brachytherapy in these situations is often a non-adaptive conebeam- CT guided boost. Conebeam-CT guided non-adaptive high dose SBRT in under these circumstances is described being quite toxic. The main questions this study aims to answer are:

  • In how many cases could local control (i.e. total disappearance of the tumor) is be achieved with this treatment?
  • Which side effects are observed in patients receiving this treatment? Participants will be asked to fill out questionnaires (e.g. regarding side effects). Furthermore, participants are asked if their clinical data may be used for study purposes.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
17mo left

Started Apr 2023

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
recruiting

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 Progress69%
Apr 2023Oct 2027

Study Start

First participant enrolled

April 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Expected
Last Updated

July 18, 2023

Status Verified

July 1, 2023

Enrollment Period

2.5 years

First QC Date

June 30, 2023

Last Update Submit

July 14, 2023

Conditions

Cervical CancerGynecologic Cancer

Keywords

RadiotherapyMRLinacGynecologic CancerLocal controlToxicityCervical Cancer

Outcome Measures

Primary Outcomes (4)

  • Local control

    Local control of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.

    3 months after MRLinac treatment

  • Local control

    Local control of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.

    6 months after MRLinac treatment

  • Local control

    Local control of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.

    12 months after MRLinac treatment

  • Local control

    Local control of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.

    24 months after MRLinac treatment

Secondary Outcomes (16)

  • Regional control

    3 months after MRLinac treatment

  • Regional control

    6 months after MRLinac treatment

  • Regional control

    12 months after MRLinac treatment

  • Regional control

    24 months after MRLinac treatment

  • Distant failure

    3 months after MRLinac treatment

  • +11 more secondary outcomes

Eligibility Criteria

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

Patients with newly biopsy proven advanced stage gynecological cancers (excluding ovarian cancers) and endometrium in whom definitive (chemo)radiotherapy with curative intent is planned are qualified for the study, as well as, patients with recurrent gynecological cancers (excluding ovarian cancers) for which no prior (chemo)radiation was performed for which (chemo)radiotherapy with curative intent is planned.

You may qualify if:

  • Patients with newly biopsy proven advanced stage gynecological cancers (excluding ovarian cancers) and endometrium in whom definitive (chemo)radiotherapy with curative intent is planned are qualified for the study, as well as, patients with recurrent gynecological cancers (excluding ovarian cancers) for which no prior (chemo)radiation was performed for which (chemo)radiotherapy with curative intent is planned.
  • Patients with para-aortic metastatic nodes (stage IVB) to the level of L2 are also eligible but patients with further dissemination are not.
  • Staging according to FIGO (2018, https://doi.org/10.1002/ijgo.12611) and TNM (version 9, 2021, https://doi.org/10.3322/caac.21663) staging.
  • Patients who gave informed consent to take part in the MOMENTUM study (NCT04075305) to use their clinical data for publication and share their data with other (European) sites.

You may not qualify if:

  • Hard contra-indication for MRI scanning

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Odense University Hospital

Odense, Denmark

RECRUITING

UMC Utrecht

Utrecht, Netherlands

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

van Lier, PhD

CONTACT

+31 88 755 8800a.l.h.m.w.vanlier@umcutrecht.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Physicist

Study Record Dates

First Submitted

June 30, 2023

First Posted

July 10, 2023

Study Start

April 1, 2023

Primary Completion

October 1, 2025

Study Completion (Estimated)

October 1, 2027

Last Updated

July 18, 2023

Record last verified: 2023-07

Locations

NL(1)DK(1)