Uterine Cervical NeoplasmsPROTECTNCT05406856
PROTECT: On-line Adaptive Proton Therapy for Cervical Cancer
A study testing External beam radiation therapy: IMRT/VMAT, External beam radiation therapy: IMPT and Cisplatin in people with Uterine Cervical Neoplasms and Locally Advanced Cervical Carcinoma, run by Leiden University Medical Center at 2 sites in Netherlands.
Trial summary
This prospective, multicenter, nonrandomized phase-II-trial investigates in clinical practice the differences between intensity modulated proton therapy (IMPT) and standard intensity-modulated radiation therapy (IMRT) or volumetric-modulated arc therapy (VMAT) in the effects on dose-volume parameters and… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Cervical Neoplasms, Locally Advanced Cervical Carcinoma
- What is being tested?
- External beam radiation therapy: IMRT/VMAT, External beam radiation therapy: IMPT and Cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesNetherlands
- Study dates
- 2 May 2022to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of cervical cancer (squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma, HPV positive or negative) with an indication for curative treatment with primary chemoradiation with concurrent cisplatin followed by 3D image-guided adaptive brachytherapy.
- Indication to include the common iliac region (minimum 5, maximum 8) or the common iliac and para-aortic regions (minimum 7, maximum 10) into the elective clinical target volume of the external beam radiotherapy.
- No distant metastasis beyond the para-aortic lymph node chain as determined by diagnostic imaging (CT or PET-CT scan)
- Age ≥ 18 years
- WHO 0-1
- Adequate systemic organ function:
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- Creatinine clearance (> 50 cc/min)
- Adequate bone marrow function : white blood cells (WBCs) ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l
- Patients must be accessible for treatment and follow-up
- Written informed consent according to the local Ethics Committee requirements
Who cannot join
- Small cell cancer, melanoma and other rare histological types of the cervix.
- History of another primary malignancy that could conceivably be active evaluated by the study physician. Examples of exception include, but are not limited to:
- Malignancy treated with curative intent and with no known active disease ≥5 years.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- Other severe diseases such as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias
- Previous pelvic or abdominal radiotherapy
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- History of active primary immunodeficiency
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g. colitis or Crohn's disease])
- The use of immunosuppressive drugs at baseline
- Contraindications for weekly Cisplatin (or Carboplatin)
- Contraindications for the use of MRI
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Recruiting
Leiden University Medical Center
Leiden, 2333 ZA
Anouk Corbeau, MSc, +31 71 529 7893, a.corbeau@lumc.nl
Stephanie M. de Boer, MD, PhD, +31 71 529 9380, s.m.de_boer.onco@lumc.nl
- Not yet recruiting
Erasmus Medical Center
Rotterdam, 3015 GD
Remi A. Nout, professor, +31 10 704 1366, r.nout@erasmusmc.nl
Jan Willem M. Mens, MD, +31 10 703 0751, j.w.m.mens@erasmusmc.nl
About this study
Official title: PROTECT: On-line Adaptive Proton Therapy for Cervical Cancer to Reduce the Impact on Morbidity and the Immune System
This prospective, multicenter, nonrandomized phase-II-trial investigates in clinical practice the differences between intensity modulated proton therapy (IMPT) and standard intensity-modulated radiation therapy (IMRT) or volumetric-modulated arc therapy (VMAT) in the effects on dose-volume parameters and treatment-related morbidity for women with locally advanced cervical cancer undergoing chemoradiation.
Read the detailed description
External beam radiation therapy (EBRT) with concurrent chemotherapy followed by brachytherapy is a highly effective treatment for locally advanced cervical cancer (LACC). However, treatment-related toxicity is common and reduces the patient's quality of life (QoL) and may affect ability to complete treatment or undergo adjuvant therapies. Intensity modulated proton therapy (IMPT) enables a significant dose reduction in organs at risk (OAR), when compared to that of standard intensity-modulated radiation therapy (IMRT) or volumetric-modulated arc therapy (VMAT). However, clinical studies evaluating whether IMPT consequently reduces side effects for LACC are lacking. The PROTECT trial is a nonrandomized prospective multicenter phase-II-trial comparing clinical outcomes after IMPT or IMRT/VMAT in LACC. Thirty women aged >18 years with a histological diagnosis of LACC will be included in either the IMPT or IMRT/VMAT group. Treatment includes EBRT (45 Gy in 25 fractions of 1.8 Gy), concurrent five weekly cisplatin (40 mg/m2), and 3D image (MRI)-guided adaptive brachytherapy. The primary endpoint is pelvic bones Dmean and mean bowel V15Gy. Secondary endpoints include dosimetric parameters, oncological outcomes, health-related QoL, immune response, safety, and tolerability. This study provides the first data on the potential of IMPT to reduce OAR dose in clinical practice and improve toxicity and QoL for patients with LACC.
- Being tested
- External beam radiation therapy: IMRT/VMAT, External beam radiation therapy: IMPT, Cisplatin, Brachytherapy
- Keywords
- Non-randomized phase-II trial, Primary chemoradiotherapy, Proton therapy, Organ sparing therapy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External beam radiation therapy: IMRT/VMATRadiation
Also called Intensity Modulated Radiation Therapy, Volumetric Modulated Arc Therapy
EBRT is given to a total dose of 45 Gy in 25 daily fractions of 1.8 Gy in 5 weeks. Involved nodes are boosted using a simultaneous integrated boost (SIB) to reach a total EBRT plus brachytherapy dose of 60 Gy EQD2 to provide high nodal control.
External beam radiation therapy: IMPTRadiation
Also called Intensity Modulated Proton Therapy
EBRT is given to a total dose of 45 Gy in 25 daily fractions of 1.8 Gy in 5 weeks. Involved nodes are boosted using a simultaneous integrated boost (SIB) to reach a total EBRT plus brachytherapy dose of 60 Gy EQD2 to provide high nodal control.
CisplatinDrug
The standard chemotherapy regimen is weekly cisplatin (40 mg/m2) for 5 weeks.
BrachytherapyRadiation
Brachytherapy is performed using a high-dose rate (HDR) after loading system to deliver a boost to any residual tumor and the cervix. Brachytherapy dose is (21-) 28 Gy in fractions of 7 Gy specified at 100% isodose around the high-risk CTV, according to the EMBRACE-II prescription protocol. The aim is to reach an equivalent dose in 2 Gy fractions including EBRT (EQD2_D90) of the high-risk CTV between 90-95 Gy, using MRI-guided adaptive brachytherapy.
| Study group | Role | What they receive |
|---|---|---|
| IMRT/VMAT group | Active comparator | This group receives standard of care curative treatment with primary external beam radiation therapy (IMRT/VMAT), combined with chemotherapy, followed by 3D image (MRI)-guided adaptive brachytherapy. Receives: Radiation: External beam radiation therapy: IMRT/VMAT; Drug: Cisplatin; Radiation: Brachytherapy |
| IMPT group | Experimental | This group receives curative treatment with primary external beam radiation therapy (IMPT), combined with chemotherapy, followed by 3D image (MRI)-guided adaptive brachytherapy. Receives: Radiation: External beam radiation therapy: IMPT; Drug: Cisplatin; Radiation: Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dmean to the pelvic bones
Mean dose to the pelvic bones (Gy).
Measured: During treatment
Mean V15Gy to the bowel
Mean volume of the bowel (cc) receiving 15Gy.
Measured: During treatment
Secondary outcomes (18)
Key dosimetric parameters of the bladder
Mean volume of the bladder (%) receiving greater than or equal to 15, 30, and 40Gy.
Measured: During treatment
Key dosimetric parameters of the rectum
Mean volume of the rectum (%) receiving greater than or equal to 15, 30, and 40Gy.
Measured: During treatment
Key dosimetric parameters of the sigmoid
Mean volume of the sigmoid (%) receiving greater than or equal to 15, 30, and 40Gy.
Measured: During treatment
Key dosimetric parameters of the bowel
Mean volume of the bowel (cc) receiving greater than or equal to 30 and 40Gy.
Measured: During treatment
Key dosimetric parameters of the body
Mean dose to the body (Gy) and mean volume of the body (cm3) receiving greater than or equal to 10 Gy.
Measured: During treatment
Key dosimetric parameters of the pelvic bones
Mean volume of the pelvic bones (% or cc) receiving greater than or equal to 10, 20, and 40Gy.
Measured: During treatment
Key dosimetric parameter of the kidneys
Mean dose to the kidneys (Gy).
Measured: During treatment
Key dosimetric parameters of the spinal cord
Mean volume of the spinal cord (%) receiving greater than or equal to 15 and 30Gy.
Measured: During treatment
Other dosimetric parameters of critical organs
Mean volume of an organ at risk (% or cc) receiving greater than or equal to xGy.
Measured: During treatment
Overall survival
The percentage (%) of included patients who are alive after start of treatment
Measured: At Month 12 after end of treatment
Complete response
Absence of disease in the cervix, uterus, upper vagina, and parametria.
Measured: At Month 3 after end of treatment
Pelvic recurrence-free survival
The time from start of treatment to the first occurrence of pelvic recurrence.
Measured: At Month 12 after end of treatment
Distant recurrence-free survival
The time from start of treatment to the first occurrence of distant recurrence.
Measured: At Month 12 after end of treatment
Health-related Quality of Life
For the evaluation of patient reported symptoms and QoL, the European Organization for Research and Treatment of Cancer (EORTC)-core (C-30) questionnaire, the CX24 module for cervical cancer, and six additional questions from EN24 module will be used.
Measured: At baseline, week 4 of EBRT, end of treatment, and at Month 3, Month 6, Month 9, and Month 12 after end of treatment
Safety and tolerability (toxicity)
Toxicity will be graded according to the NCI-CTCAE version 5.0.
Measured: At baseline, week 4 of EBRT, end of treatment, and at Month 3, Month 6, Month 9, and Month 12 after end of treatment
The effect on the local immune system (analyzed with the Nanostring PanCancer IO 360 panel)
Tumor biopsies will be collected for evaluation of the impact of treatment on the local immune response.
Measured: At baseline and at the first brachytherapy session
The effect on the systemic immune system
Blood samples will be collected for immune-monitoring. Full blood count, peripheral blood mononuclear cells, leukocyte differentiation, APC quality, T cell reactivity, and immune composition changes will be measured.
Measured: At baseline, week 4 of treatment, and at Month 1, Month 2, Month 3, and Month 12 after end of treatment
The effect on bone marrow fat fraction
Patients will have an MR scan with Dixon technique for evaluation of bone marrow fat fraction in the vertebral column and femoral necks.
Measured: At baseline, for brachytherapy purposes, and at Month 3 and Month 12 after end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start2 May 2022
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine Cervical NeoplasmsStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The study is designed as a prospective, multicenter, nonrandomized phase-II-trial. During the first phase of the trial, 15 patients will be enrolled in the IMRT/VMAT treatment group. In the second phase of the trial, 15 patients will be enrolled in the IMPT group.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center, HollandPTC
- Responsible party
- Principal investigator, Carien Creutzberg, Leiden University Medical Center
- Investigators
- Stephanie M. de Boer, MD, PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406856
- Sponsor's protocol ID
- NL77911.058.21
- Acronym
- PROTECT
- Status last verified
- Oct 2023
- First submitted
- 11 May 2022
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After completion of the trial and publication of the final results, data will be available upon request with a scientific proposal. Approval by the trial management group is necessary.
Publications
Corbeau A, Nout RA, Mens JWM, Horeweg N, Godart J, Kerkhof EM, Kuipers SC, van Poelgeest MIE, Kroep JR, Boere IA, van Doorn HC, Hoogeman MS, van der Heide UA, Putter H, Welters MJP, van der Burg SH, Creutzberg CL, de Boer SM. PROTECT: Prospective Phase-II-Trial Evaluating Adaptive Proton Therapy for Cervical Cancer to Reduce the Impact on Morbidity and the Immune System. Cancers (Basel). 2021 Oct 15;13(20):5179. doi: 10.3390/cancers13205179.
PubMed 34680328
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROTECT: On-line Adaptive Proton Therapy for Cervical Cancer to Reduce the Impact on Morbidity and the Immune System
- ClinicalTrials.gov ID
- NCT05406856
- Acronym / sponsor ID
- PROTECT / NL77911.058.21
- Keywords
- Non-randomized phase-II trial, Primary chemoradiotherapy, Proton therapy, Organ sparing therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Erasmus Medical Center, HollandPTC
- Study start
- 2 May 2022 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 7 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, multicenter, nonrandomized phase-II-trial investigates in clinical practice the differences between intensity modulated proton therapy (IMPT) and standard intensity-modulated radiation therapy (IMRT) or volumetric-modulated arc therapy (VMAT) in the effects on dose-volume parameters and treatment-related morbidity for women with locally advanced cervical cancer undergoing chemoradiation.
Detailed description
External beam radiation therapy (EBRT) with concurrent chemotherapy followed by brachytherapy is a highly effective treatment for locally advanced cervical cancer (LACC). However, treatment-related toxicity is common and reduces the patient's quality of life (QoL) and may affect ability to complete treatment or undergo adjuvant therapies. Intensity modulated proton therapy (IMPT) enables a significant dose reduction in organs at risk (OAR), when compared to that of standard intensity-modulated radiation therapy (IMRT) or volumetric-modulated arc therapy (VMAT). However, clinical studies evaluating whether IMPT consequently reduces side effects for LACC are lacking. The PROTECT trial is a nonrandomized prospective multicenter phase-II-trial comparing clinical outcomes after IMPT or IMRT/VMAT in LACC. Thirty women aged >18 years with a histological diagnosis of LACC will be included in either the IMPT or IMRT/VMAT group. Treatment includes EBRT (45 Gy in 25 fractions of 1.8 Gy), concurrent five weekly cisplatin (40 mg/m2), and 3D image (MRI)-guided adaptive brachytherapy. The primary endpoint is pelvic bones Dmean and mean bowel V15Gy. Secondary endpoints include dosimetric parameters, oncological outcomes, health-related QoL, immune response, safety, and tolerability. This study provides the first data on the potential of IMPT to reduce OAR dose in clinical practice and improve toxicity and QoL for patients with LACC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is designed as a prospective, multicenter, nonrandomized phase-II-trial. During the first phase of the trial, 15 patients will be enrolled in the IMRT/VMAT treatment group. In the second phase of the trial, 15 patients will be enrolled in the IMPT group.
| Arm | Type | Receives |
|---|---|---|
| IMRT/VMAT group | Active comparator | Radiation: External beam radiation therapy: IMRT/VMAT, Drug: Cisplatin, Radiation: BrachytherapyThis group receives standard of care curative treatment with primary external beam radiation therapy (IMRT/VMAT), combined with chemotherapy, followed by 3D image (MRI)-guided adaptive brachytherapy. |
| IMPT group | Experimental | Radiation: External beam radiation therapy: IMPT, Drug: Cisplatin, Radiation: BrachytherapyThis group receives curative treatment with primary external beam radiation therapy (IMPT), combined with chemotherapy, followed by 3D image (MRI)-guided adaptive brachytherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed diagnosis of cervical cancer (squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma, HPV positive or negative) with an indication for curative treatment with primary chemoradiation with concurrent cisplatin followed by 3D image-guided adaptive brachytherapy.
- Indication to include the common iliac region (minimum 5, maximum 8) or the common iliac and para-aortic regions (minimum 7, maximum 10) into the elective clinical target volume of the external beam radiotherapy.
- No distant metastasis beyond the para-aortic lymph node chain as determined by diagnostic imaging (CT or PET-CT scan)
- Age ≥ 18 years
- WHO 0-1
Key exclusion criteria (11 listed)
- Small cell cancer, melanoma and other rare histological types of the cervix.
- History of another primary malignancy that could conceivably be active evaluated by the study physician. Examples of exception include, but are not limited to:
- Other severe diseases such as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias
- Previous pelvic or abdominal radiotherapy
- History of active primary immunodeficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External beam radiation therapy: IMRT/VMATAlso: Intensity Modulated Radiation Therapy, Volumetric Modulated Arc TherapyEBRT is given to a total dose of 45 Gy in 25 daily fractions of 1.8 Gy in 5 weeks. Involved nodes are boosted using a simultaneous integrated boost (SIB) to reach a total EBRT plus brachytherapy dose of 60 Gy EQD2 to provide high nodal control. | Radiation | IMRT/VMAT group |
| External beam radiation therapy: IMPTAlso: Intensity Modulated Proton TherapyEBRT is given to a total dose of 45 Gy in 25 daily fractions of 1.8 Gy in 5 weeks. Involved nodes are boosted using a simultaneous integrated boost (SIB) to reach a total EBRT plus brachytherapy dose of 60 Gy EQD2 to provide high nodal control. | Radiation | IMPT group |
| CisplatinThe standard chemotherapy regimen is weekly cisplatin (40 mg/m2) for 5 weeks. | Drug | IMPT group, IMRT/VMAT group |
| BrachytherapyBrachytherapy is performed using a high-dose rate (HDR) after loading system to deliver a boost to any residual tumor and the cervix. Brachytherapy dose is (21-) 28 Gy in fractions of 7 Gy specified at 100% isodose around the high-risk CTV, according to the EMBRACE-II prescription protocol. The aim is to reach an equivalent dose in 2 Gy fractions including EBRT (EQD2_D90) of the high-risk CTV between 90-95 Gy, using MRI-guided adaptive brachytherapy. | Radiation | IMPT group, IMRT/VMAT group |
Primary outcome
Dmean to the pelvic bones
Time frame: During treatment
Mean dose to the pelvic bones (Gy).
Mean V15Gy to the bowel
Time frame: During treatment
Mean volume of the bowel (cc) receiving 15Gy.
18 secondary outcomes
Key dosimetric parameters of the bladder
Time frame: During treatment
Key dosimetric parameters of the rectum
Time frame: During treatment
Key dosimetric parameters of the sigmoid
Time frame: During treatment
Key dosimetric parameters of the bowel
Time frame: During treatment
Key dosimetric parameters of the body
Time frame: During treatment
Key dosimetric parameters of the pelvic bones
Time frame: During treatment
Key dosimetric parameter of the kidneys
Time frame: During treatment
Key dosimetric parameters of the spinal cord
Time frame: During treatment
Other dosimetric parameters of critical organs
Time frame: During treatment
Overall survival
Time frame: At Month 12 after end of treatment
Complete response
Time frame: At Month 3 after end of treatment
Pelvic recurrence-free survival
Time frame: At Month 12 after end of treatment
Distant recurrence-free survival
Time frame: At Month 12 after end of treatment
Health-related Quality of Life
Time frame: At baseline, week 4 of EBRT, end of treatment, and at Month 3, Month 6, Month 9, and Month 12 after end of treatment
Safety and tolerability (toxicity)
Time frame: At baseline, week 4 of EBRT, end of treatment, and at Month 3, Month 6, Month 9, and Month 12 after end of treatment
The effect on the local immune system (analyzed with the Nanostring PanCancer IO 360 panel)
Time frame: At baseline and at the first brachytherapy session
The effect on the systemic immune system
Time frame: At baseline, week 4 of treatment, and at Month 1, Month 2, Month 3, and Month 12 after end of treatment
The effect on bone marrow fat fraction
Time frame: At baseline, for brachytherapy purposes, and at Month 3 and Month 12 after end of treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Background: PubMed 34680328Corbeau A, Nout RA, Mens JWM, Horeweg N, Godart J, Kerkhof EM, Kuipers SC, van Poelgeest MIE, Kroep JR, Boere IA, van Doorn HC, Hoogeman MS, van der Heide UA, Putter H, Welters MJP, van der Burg SH, Creutzberg CL, de Boer SM. PROTECT: Prospective Phase-II-Trial Evaluating Adaptive Proton Therapy for Cervical Cancer to Reduce the Impact on Morbidity and the Immune System. Cancers (Basel). 2021 Oct 15;13(20):5179. doi: 10.3390/cancers13205179.
- Individual participant dataSharing planned: Yes. After completion of the trial and publication of the final results, data will be available upon request with a scientific proposal. Approval by the trial management group is necessary.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephanie M. de Boer, MD, PhD principal investigator
Leiden University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External beam radiation therapy: IMRT/VMAT, External beam radiation therapy: IMPT and Cisplatin in people with Uterine Cervical Neoplasms and Locally Advanced Cervical Carcinoma, run by Leiden University Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anouk Corbeau, MSc (+31 71 529 7893, a.corbeau@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dmean to the pelvic bones (time frame: During treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05406856, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.