To develop an MRI-guided adaptive radiotherapy workflow for patients with locally advanced cervical cancer, aimed at achieving more precise target coverage and better critical organ sparing.
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
We will develop a new workflow for MRI-guided adaptive radiotherapy, assessing
the accuracy of semi-automatic delineation of target volume and critical
organs. Treatment remains according to standard clinical practice, but we will
(digitally) simulate our new workflow using the acquired MRI scans.
Secondary outcome
NA
Background summary
Standard therapy for locally advanced cervical cancer (International Federation
of Gynecology and Obstetrics (FIGO) stages IB2, IIA2, IIB, IIIA, IIIB, or IVA)
[1] is chemoradiotherapy (CRT). Common side effects from this treatment are
cystitis, enteritis, proctitis, bone marrow suppression and vaginal stenosis
[2-6]. These side effects influence quality of life, and also limit further
extension of the radiation fields, and/or the introduction of adjuvant
chemotherapy, for high-risk patients.
Adaptive radiotherapy, in which treatment margins are safely reduced using
daily imaging, holds great promise for minimization of side effects from
radiotherapy. In this study, we want to simulate and develop a new workflow for
MRI-guided adaptive radiotherapy. We propose to simulate daily imaging by
acquiring three additional MRI scans during regular clinical treatment for
locally advanced cervical cancer.
Study objective
To develop an MRI-guided adaptive radiotherapy workflow for patients with
locally advanced cervical cancer, aimed at achieving more precise target
coverage and better critical organ sparing.
Study design
Single-center observational study investigating the potential of an MRI-guided
adaptive radiotherapy workflow for patients with locally advanced cervical
cancer.
Study burden and risks
Three extra MRI scans (without contrast agents) will be acquired taking a
total of 80 minutes extra time. This procedure is considered to be free of any
risks. No extra hospital visits are required. The treating physician will
evaluate the clinical treatment plan using the additional MRI scans during
treatment; in some cases this may result in treatment plan adaptation which may
lead to patient benefit.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
* Clinical indication for chemoradiotherapy with curative intent (one of the following):
-FIGO [1] stage IA, IB1 or IIA1 cervical cancer with regional lymph node pathology,
-FIGO stage IA, IB1 or IIA1 cervical cancer with contraindications for surgery
-FIGO stage IB2, IIA2, IIB, IIIA, IIIB, or IVA cervical cancer
* Medical condition that allows chemoradiotherapy with curative intent
* Age * 18 years
* Signed informed consent, obtained before the acquisition of the first additional MRI scan
* Able to comply with the variable bladder filling protocol (drinking and voiding instructions, this protocol is part of standard clinical care)
Exclusion criteria
* Patients who meet exclusion criteria for MRI at 1.5T following the protocol of the department of Radiology of the UMC Utrecht
* Patients who are mentally or otherwise disabled and/or considered legally incapable
* History of previous pelvic radiotherapy
* Pregnant or breast-feeding patients
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL54660.041.15 |