Prostate CancerFASCINATENCT06691776
Feasibility of CBCT-Guided Online Adaptive Radiotherapy (FASCINATE)
A study testing online CBCT-guided adaptive radiation therapy using a new software in people with Prostate Cancer and Cervical Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
The accuracy of radiotherapy can be increased by correcting for geometric uncertainties and changes between radiotherapy fractions. These corrections are currently done with online adaptive treatment on a specialized linear accelerator (linac) for a small subset of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Cervical Cancer, Bladder Cancer
- What is being tested?
- online CBCT-guided adaptive radiation therapy using a new software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 29 Aug 2023to 1 Dec 2028
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
General Inclusion Criteria:
- Patient, age ≥ 18 years, referred for a radiotherapy schedule as described in one of the cohorts.
- WHO performance score 0-3.
- Provision of signed, written and dated IC prior to any study specific procedures.
Specific inclusion criteria for prostate cohort:
- Accepted for radiotherapy of the prostate and pelvic lymph node areas.
- Pathology-proven prostate cancer.
- cT1-4
- cN1 on PSMA-PET/CT or pN1 based on node biopsy, SN-procedure or lymph node dissection.
- cM0 on PSMA-PET/CT (except for patients with M1a disease who are still considered for radiotherapy of the prostate and pelvic lymph node areas).
Specific inclusion criteria for cervical cohort:
- Accepted for radiotherapy of the cervix (with or without chemotherapy) and pelvic lymph node areas (25 fractions, followed by either a brachytherapy or external radiotherapy boost).
- Pathology-proven cervical cancer.
- FIGO IIA2, IB3 and > 6cm, IIB-IVA or N+. Or other stage and unfit for surgery.
- cM0 or cM1 and accepted for locoregional radical (chemo)radiation in 25 fractions.
Specific inclusion criteria for bladder cohort:
- Accepted for radiotherapy of the bladder, either to the entire bladder or with a boost to the tumor area (with or without chemotherapy).
- Pathology-proven bladder carcinoma.
- cT1-4
- cN0 or cN1-2 after induction treatment (with or without lymph node dissection)
Specific inclusion criteria for lung cohort:
- Accepted for radiotherapy for lung cancer with lymph node metastases (with or without chemotherapy).
- Non-small cell lung cancer (either pathology proven or enough clinical suspicion to warrant radiotherapy to primary tumor and pathologic lymph nodes.
- cT1-4 and cN1-3.
- M0 or m1 and accepted for radical radiotherapy in 24 fractions of 1 or more lymph node metastases and a primary tumor and/or pulmonary metastases.
Specific inclusion criteria for head and neck cohort:
- Accepted for radiotherapy for head and neck cancer (with or without chemotherapy).
- Pathology-proven carcinoma of the pharynx, oral cavity or larynx.
- cT1-4
- cN0-3 and indication for elective neck radiation (either 1 or 2 sides).
- cM0
General Exclusion Criteria:
- Patients who are pregnant.
Specific for prostate cohort:
- Patients with a medical condition that severely compromises CBCT image quality (mainly hip prostheses).
- Severe lower urinary tract symptoms that could make the longer treatment time problematic (according to judgement of treating physician).
Specific for cervical cohort:
- Patients with a medical condition that severely compromises CBCT image quality (mainly hip prostheses).
Specific for bladder cohort:
- Patients with a medical condition that severely compromises CBCT image quality (mainly hip prostheses).
- Severe lower urinary tract symptoms that could make the longer treatment time problematic (according to judgement of treating physician).
Specific for lung cohort:
- Severe pulmonary complaints that could make the longer treatment time problematic (according to judgement of treating physician).
Specific for head and neck cohort:
- Severe complaints that could make the longer treatment time problematic (according to judgement of treating physician).
- Pulmonary fibrosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Antoni van Leeuwenhoek Hospital
Amsterdam
Z Gouw
About this study
Official title: FASCINATE: FeASibility of Cbct-guIded oNline Adaptive radioThErapy
The accuracy of radiotherapy can be increased by correcting for geometric uncertainties and changes between radiotherapy fractions. These corrections are currently done with online adaptive treatment on a specialized linear accelerator (linac) for a small subset of patients. However, patients currently treated on a standard linac could also benefit from online adaptive radiotherapy. The objective is to determine the feasibility of online CBCT-guided adaptive radiation therapy on a standard Elekta linac.
- Being tested
- online CBCT-guided adaptive radiation therapy using a new software
- Medical subject headings
- Prostatic Neoplasms, Uterine Cervical Neoplasms, Urinary Bladder Neoplasms, Lung Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online CBCT-guided adaptive radiation therapy using a new softwareDevice
Patients are treated in the NKI with CBCT-guided online adaptive radiotherapy. While in the clinical workflow one planning CT is used to make the radiotherapy plan, this study treatment creates a new radiotherapy plan on the day of every treatment fraction. Instead of directly irradiating, the radiotherapy plan is adjusted to the anatomy of the day.
| Study group | Role | What they receive |
|---|---|---|
| Adapt to rotation for prostate and elective lymph node irradiation | Experimental | The CBCT will be matched (translated and rotated) to the original planning CT with the clinical image registration software. A new software (the rotation simulator) reads both the match of the bony anatomy and the match of the prostate. This software also imports the original planning CT and structures and deforms the original planning CT to match the rotations and translations of pelvis and prostate, as seen in the CBCT. Both these new radiotherapy planning structures and the deformed planning CT are exported to the radiotherapy planning software (Monaco) and used to calculate the adaptive plan. This newly calculated plan will be exported to Mosaiq to treat the patient. Receives: Device: online CBCT-guided adaptive radiation therapy using a new software |
| CBCT-guided online adaptation for cervical cancer and elective lymph node irradiation | Experimental | The CBCT will be matched (translated and rotated) to the original planning CT with the clinical image registration software. With in-house software, the target areas and the OARs will be deformed to or segmented on the anatomy of the CBCT. These adjusted radiotherapy structures are then send to the radiotherapy planning software (Monaco). There, the structures are visually inspected and, if needed, manually adjusted. Afterwards, Monaco calculates a new, online adaptive radiotherapy plan. After checking, the plan is exported to Mosaiq to treat the patient. Receives: Device: online CBCT-guided adaptive radiation therapy using a new software |
| CBCT-guided online adaptation for bladder cancer. | Experimental | The CBCT will be matched (translated and rotated) to the original planning CT with the clinical image registration software. With in-house software, the target areas and the OARs will be deformed or segmented to the anatomy of the CBCT. These adjusted radiotherapy structures are then send to the radiotherapy planning software (Monaco). There, the structures are visually inspected and, if needed, manually adjusted. Afterwards, Monaco calculates a new, online adaptive radiotherapy plan. After checking, the plan is exported to Mosaiq to treat the patient. Receives: Device: online CBCT-guided adaptive radiation therapy using a new software |
| CBCT-guided online adaptation for lung cancer | Experimental | The CBCT will be matched (translated and rotated) to the original planning CT with the clinical image registration software. The rotation simulator reads both the registration of the primary tumor and of the lymph nodes (via the carina). This software also imports the original planning CT and structures and deforms the original planning CT to match the rotations and translations of the primary tumor and lymph nodes, as seen in the CBCT. Both these new radiotherapy planning structures and the deformed planning CT are exported to the radiotherapy planning software (Monaco) and used to calculate the adaptive plan. This newly calculated plan will be exported to Mosaiq to treat the patient. Receives: Device: online CBCT-guided adaptive radiation therapy using a new software |
| CBCT-guided online adaptation for head and neck cancer | Experimental | The CBCT will be matched (translated and rotated) to the original planning CT with the clinical image registration software. The rotation simulator reads the image registration of the primary tumor and the match of the lymph node areas. This software also imports the original planning CT and structures and deforms the original planning CT to match the rotations and translations of the primary tumor and lymph node areas, as seen in the CBCT. Both these new radiotherapy planning structures and the deformed planning CT are exported to the radiotherapy planning software (Monaco) and used to calculate the adaptive plan. This newly calculated plan will be exported to Mosaiq to treat the patient. Receives: Device: online CBCT-guided adaptive radiation therapy using a new software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: successful application of the online adaptive treatment in 90% of 20 patients
The adaptive treatment is feasible if the technique is successfully ap-plied in 90% of 20 patients.
Measured: From first fraction until the last fraction, an average of 20-35 fractions
Secondary outcomes (1)
Safety: Treatment associated ≥ grade 3 acute toxicity according to the NCI Common Terminology Criteria of Adverse Events (CTCAE version 5.0).
Treatment associated ≥ grade 3 acute toxicity according to the NCI Common Terminology Criteria of Adverse Events (CTCAE version 5.0).
Measured: From Baseline until 3 months after the last radiotherapy fraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start29 Aug 2023
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe 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
- Parallel groups
- Model description
- A prospective, non-randomized basket trial of the technical feasibility and safety of new software/technologies for CBCT-guided online adaptive radiotherapy. Patients will be enrolled in multiple parallel cohorts, each defined by tumor type(s), and a technical design for the online adaptation.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691776
- Sponsor's protocol ID
- N23FAS
- Acronym
- FASCINATE
- Status last verified
- Jul 2025
- First submitted
- 13 Jul 2023
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FASCINATE: FeASibility of Cbct-guIded oNline Adaptive radioThErapy
- ClinicalTrials.gov ID
- NCT06691776
- Acronym / sponsor ID
- FASCINATE / N23FAS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 29 Aug 2023 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 15 Nov 2024 (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.
The accuracy of radiotherapy can be increased by correcting for geometric uncertainties and changes between radiotherapy fractions. These corrections are currently done with online adaptive treatment on a specialized linear accelerator (linac) for a small subset of patients. However, patients currently treated on a standard linac could also benefit from online adaptive radiotherapy. The objective is to determine the feasibility of online CBCT-guided adaptive radiation therapy on a standard Elekta linac.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- A prospective, non-randomized basket trial of the technical feasibility and safety of new software/technologies for CBCT-guided online adaptive radiotherapy. Patients will be enrolled in multiple parallel cohorts, each defined by tumor type(s), and a technical design for the online adaptation.
| Arm | Type | Receives |
|---|---|---|
| Adapt to rotation for prostate and elective lymph node irradiation | Experimental | Device: online CBCT-guided adaptive radiation therapy using a new softwareThe CBCT will be matched (translated and rotated) to the original planning CT with the clinical image registration software. A new software (the rotation simulator) reads both the match of the bony anatomy and the match of the prostate. This software also imports the original planning CT and structures and deforms the original planning CT to match the rotations and translations of pelvis and prostate, as seen in the CBCT. Both these new radiotherapy planning structures and the deformed planning CT are exported to the radiotherapy planning software (Monaco) and used to calculate the adaptive plan. This newly calculated plan will be exported to Mosaiq to treat the patient. |
| CBCT-guided online adaptation for cervical cancer and elective lymph node irradiation | Experimental | Device: online CBCT-guided adaptive radiation therapy using a new softwareThe CBCT will be matched (translated and rotated) to the original planning CT with the clinical image registration software. With in-house software, the target areas and the OARs will be deformed to or segmented on the anatomy of the CBCT. These adjusted radiotherapy structures are then send to the radiotherapy planning software (Monaco). There, the structures are visually inspected and, if needed, manually adjusted. Afterwards, Monaco calculates a new, online adaptive radiotherapy plan. After checking, the plan is exported to Mosaiq to treat the patient. |
| CBCT-guided online adaptation for bladder cancer. | Experimental | Device: online CBCT-guided adaptive radiation therapy using a new softwareThe CBCT will be matched (translated and rotated) to the original planning CT with the clinical image registration software. With in-house software, the target areas and the OARs will be deformed or segmented to the anatomy of the CBCT. These adjusted radiotherapy structures are then send to the radiotherapy planning software (Monaco). There, the structures are visually inspected and, if needed, manually adjusted. Afterwards, Monaco calculates a new, online adaptive radiotherapy plan. After checking, the plan is exported to Mosaiq to treat the patient. |
| CBCT-guided online adaptation for lung cancer | Experimental | Device: online CBCT-guided adaptive radiation therapy using a new softwareThe CBCT will be matched (translated and rotated) to the original planning CT with the clinical image registration software. The rotation simulator reads both the registration of the primary tumor and of the lymph nodes (via the carina). This software also imports the original planning CT and structures and deforms the original planning CT to match the rotations and translations of the primary tumor and lymph nodes, as seen in the CBCT. Both these new radiotherapy planning structures and the deformed planning CT are exported to the radiotherapy planning software (Monaco) and used to calculate the adaptive plan. This newly calculated plan will be exported to Mosaiq to treat the patient. |
| CBCT-guided online adaptation for head and neck cancer | Experimental | Device: online CBCT-guided adaptive radiation therapy using a new softwareThe CBCT will be matched (translated and rotated) to the original planning CT with the clinical image registration software. The rotation simulator reads the image registration of the primary tumor and the match of the lymph node areas. This software also imports the original planning CT and structures and deforms the original planning CT to match the rotations and translations of the primary tumor and lymph node areas, as seen in the CBCT. Both these new radiotherapy planning structures and the deformed planning CT are exported to the radiotherapy planning software (Monaco) and used to calculate the adaptive plan. This newly calculated plan will be exported to Mosaiq to treat the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| online CBCT-guided adaptive radiation therapy using a new softwarePatients are treated in the NKI with CBCT-guided online adaptive radiotherapy. While in the clinical workflow one planning CT is used to make the radiotherapy plan, this study treatment creates a new radiotherapy plan on the day of every treatment fraction. Instead of directly irradiating, the radiotherapy plan is adjusted to the anatomy of the day. | Device | Adapt to rotation for prostate and elective lymph node irradiation, CBCT-guided online adaptation for bladder cancer., CBCT-guided online adaptation for cervical cancer and elective lymph node irradiation, CBCT-guided online adaptation for head and neck cancer, CBCT-guided online adaptation for lung cancer |
Primary outcome
Feasibility: successful application of the online adaptive treatment in 90% of 20 patients
Time frame: From first fraction until the last fraction, an average of 20-35 fractions
The adaptive treatment is feasible if the technique is successfully ap-plied in 90% of 20 patients.
1 secondary outcome
Safety: Treatment associated ≥ grade 3 acute toxicity according to the NCI Common Terminology Criteria of Adverse Events (CTCAE version 5.0).
Time frame: From Baseline until 3 months after the last radiotherapy fraction
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 1 Aug 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing online CBCT-guided adaptive radiation therapy using a new software in people with Prostate Cancer and Cervical Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Evelien Schouten, MSc (+31205129140, ev.schouten@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: successful application of the online adaptive treatment in 90% of 20 patients (time frame: From first fraction until the last fraction, an average of 20-35 fractions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2025.