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| Name | Class |
|---|---|
| Odense University Hospital | OTHER |
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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:
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.
Standard treatment of locally advanced cervical cancer is chemoradiotherapy (external beam radiotherapy (EBRT) and concomitant chemotherapy with weekly Cisplatin) followed by image guided brachytherapy (IGBT). Recently, the MR Linac has emerged as new option for delivering an external beam radiotherapy boost to the primary cervical tumour after (chemo)radiaton in case brachytherapy is not feasible. MR Linac in these cases can replace traditional EBRT boosts and allow for better visualisation of the anatomy, smaller treatment margins and online treatment planning adaptation. This comes with potential for higher dose to the target and less dose to the surrounding organs.
Like in IGBT, an MRL treatment provides the possibility to perform repetitive imaging before and even during each fraction and allows for dose adaptation to anatomical changes in individual patients. This way not not only the daily position of OARs in relation to the target can be taken into account, but also possible tumor regression which often is obtained during chemoradiation. Based on the experience collected so far, the MRL treatment may be an interesting treatment option in selected cases as daily MRI and plan adaptation leads to more confined dose distribution compared to CBCT-Linac options. However, dose levels for the MRL-boost are likely to be lower than for IGBT, therefore its effectiveness is still unsure.
Aims of the study:
Type of design
This study is a multicenter prospective observational study. Patient registration and dosimetric reporting will be performed in the individual centers.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Regional control |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| van Lier, PhD | Contact | +31 88 755 8800 | a.l.h.m.w.vanlier@umcutrecht.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Recruiting | Odense | Denmark |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| UMC Utrecht | Recruiting | Utrecht | Netherlands |
|
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |