Cervical Cancer Clinical Trial
— MARGARITAOfficial title:
MRLinac Boost for Gynecological Cancers if Brachytherapy is Not Feasible
NCT number | NCT05937958 |
Other study ID # | |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 1, 2023 |
Est. completion date | October 1, 2027 |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | October 1, 2027 |
Est. primary completion date | October 1, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - Hard contra-indication for MRI scanning |
Country | Name | City | State |
---|---|---|---|
Denmark | Odense University Hospital | Odense | |
Netherlands | UMC Utrecht | Utrecht |
Lead Sponsor | Collaborator |
---|---|
UMC Utrecht | Odense University Hospital |
Denmark, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Regional control | Regional 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 | |
Secondary | Regional control | Regional 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 | |
Secondary | Regional control | Regional 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 | |
Secondary | Regional control | Regional 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 | Distant failure | Distant failure of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care | 3 months after MRLinac treatment | |
Secondary | Distant failure | Distant failure of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care | 12 months after MRLinac treatment | |
Secondary | Distant failure | Distant failure of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care | 24 months after MRLinac treatment | |
Secondary | Gastrointestinal toxicity | Gastrointestinal toxicity of participating patients will be obtained from the hospital information systems. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary. Patient recorded outcome is (tumor specific) questionaires. See MOMENTUM study (NCT04075305) | 3 months after MRLinac treatment | |
Secondary | Gastrointestinal toxicity | Gastrointestinal toxicity of participating patients will be obtained from the hospital information systems. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary. Patient recorded outcome is (tumor specific) questionaires. See MOMENTUM study (NCT04075305) | 6 months after MRLinac treatment | |
Secondary | Gastrointestinal toxicity | Gastrointestinal toxicity of participating patients will be obtained from the hospital information systems. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary. Patient recorded outcome is (tumor specific) questionaires. See MOMENTUM study (NCT04075305) | 24 months after MRLinac treatment | |
Secondary | Urogenital toxicity | Urogenital toxicity of participating patients will be obtained from the hospital information systems. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary. Patient recorded outcome is (tumor specific) questionaires. See MOMENTUM study (NCT04075305) | 3 months after MRLinac treatment | |
Secondary | Urogenital toxicity | Urogenital toxicity of participating patients will be obtained from the hospital information systems. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary. Patient recorded outcome is (tumor specific) questionaires. See MOMENTUM study (NCT04075305) | 6 months after MRLinac treatment | |
Secondary | Urogenital toxicity | Urogenital toxicity of participating patients will be obtained from the hospital information systems. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary. Patient recorded outcome is (tumor specific) questionaires. See MOMENTUM study (NCT04075305) | 24 months after MRLinac treatment | |
Secondary | Vaginal toxicity | Vaginal toxicity of participating patients will be obtained from the hospital information systems. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary. Patient recorded outcome is (tumor specific) questionaires. See MOMENTUM study (NCT04075305) | 3 months after MRLinac treatment | |
Secondary | Vaginal toxicity | Vaginal toxicity of participating patients will be obtained from the hospital information systems. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary. Patient recorded outcome is (tumor specific) questionaires. See MOMENTUM study (NCT04075305) | 6 months after MRLinac treatment | |
Secondary | Vaginal toxicity | Vaginal toxicity of participating patients will be obtained from the hospital information systems. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary. Patient recorded outcome is (tumor specific) questionaires. See MOMENTUM study (NCT04075305) | 24 months after MRLinac treatment |
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