Head and Neck CancerPhase 1MRL-02NCT05160714
Individualized Response-adaptive Radiation Dose Prescription in HNC Based on MRI
A Phase 1 study testing Real-time ADC-guided response adaptive Boost in HNC in people with Head and Neck Cancer, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
This Phase 1 dose-finding study investigates the maximal tolerated dose for a subsequent phase 2 trial testing MR-guided individualized response-adaptive dose prescription in HNC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Real-time ADC-guided response adaptive Boost in HNC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2022to 30 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
Who may be able to join
- Age: older than 18 years
- WHO (ECOG) performance status 0-2
- Histological proven HNC (squamous cell carcinoma)
- HPV negative tumors or high risk HPV positive tumors
- Stage III - IVB HNC of the hypopharynx, oropharynx and oral cavity according to UICC and AJCC guidelines
- Tumor extension and localization suitable for radiochemotherapy with curative intent
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- Simultaneous standard chemotherapy with cisplatin applicable (no contra-indications)
- Dental examination and -treatment before start of therapy
- For women with childbearing potential and men in reproductive ages adequate contraception.
- Ability of subject to understand character and individual consequences of the clinical trial
- Written informed consent (must be available before enrolment in the trial)
Who cannot join
- Refusal of the patients to take part in the trial
- Presence of distant metastases (UICC stage IVC)
- HPV positive tumors UICC Stage III with T1/2 N3, despite of smoking status
- Previous radiotherapy in the head and neck region
- Second malignancy that is likely to require treatment during the trial intervention or follow-up period or that, in the opinion of the physician, has a considerable risk of recurrence or metastases within the follow-up period
- Serious disease or medical condition with life expectancy of less than one year
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- Participation in competing interventional trial on cancer treatment
- Patients who are not suitable for radiochemotherapy
- Pregnant or lactating women
- Patients not able to understand the character and individual consequences of the trial
- Nasopharyngeal and glottis laryngeal carcinomas
- Patients with contraindications for magnet-resonance tomography
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
UKT Radiooncology
Tübingen, Baden-Wurttemberg, 72076
Simon Böke, MD, +49 7071 29 ext. 82165, roinfo@med.uni-tuebingen.de
About this study
Official title: Individualized Response-adaptive Radiation Dose Prescription in HNC Based on MRI - Real-time ADC-guided Response Adaptive Boost in HNC - "Individuelle MR-basierte Dosisverschreibung Bei Kopf-Hals-Tumoren - ADC-basierter Adaptiver Boost"
This Phase 1 dose-finding study investigates the maximal tolerated dose for a subsequent phase 2 trial testing MR-guided individualized response-adaptive dose prescription in HNC.
Read the detailed description
This single-center, non-randomized interventional dose-finding phase I trial evaluates the maximal tolerated boost dose with respect to dose limiting toxicities in patients with locally advanced head and neck squamous cell carcinoma (UICC stage III/IVB) with an indication for a primary radiochemotherapy. The primary aim of the trial is to define the maximal tolerated dose in an ADC-based subvolume using an adaptive SBRT-boost areal. Dose-escalated SBRT boost to ADC-high risk volume will be delivered once a week and is defined according to the the actual imaging immediately performed prior to delivery (real-time adaptive) i.e. it can vary from one week to another and it might also be reduced throughout the course of treatment (response adaptive). In case of complete disappearance of high-risk subvolumes sufficient large enough to boost (<5ml), no further ADC boost but only the floor-boost dose is given. The dose escalation of the ADC-high risk volume boost is graduated in four dose levels of 5x5 Gy, 5x5.5 Gy, 5x6 Gy, 5x6.5 Gy in a classical 3+3 dose-finding design where 3 patients per radiation dose level are enrolled. Primary endpoint is the dose limiting toxicity, any acute and late non-hematologic grade 4 or 5 related to the radiotherapy intervention, ≥ grade 3 CTC v.5. oral mucositis at 3 months after radiotherapy.
- Conditions
- Head and Neck Cancer
- Being tested
- Real-time ADC-guided response adaptive Boost in HNC
- Keywords
- Radiotherapy, MR-guided Radiotherapy, dose-finding study, MR-Linac, ADC-guided response adaptive Boost
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time ADC-guided response adaptive Boost in HNCRadiation
40 Gy in 20 fractions over 5 weeks (Monday to Thursday) to the adjuvant neck, simultaneous integrated boost with 56 Gy in 20 fractions in 5 weeks to the low-risk macroscopic tumor.
Once weekly Dose-escalated SBRT adaptive boost to an ADC-based high risk subvolume with graduated dose levels of 5x5 Gy, 5x5.5 Gy, 5x6 Gy, 5x6.5 Gy
| Study group | Role | What they receive |
|---|---|---|
| Adaptive SBRT Boost | Experimental | Dose-escalated SBRT boost to an ADC-based high risk subvolume in HNC Receives: Radiation: Real-time ADC-guided response adaptive Boost in HNC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
Dose limiting toxicity (DLT): any acute and late grade 4 or 5 related to the intervention, ≥ grade 3 CTC v.5. oral mucositis at 3 months after radiotherapy (persistent mucosal ulceration or inflammation in the high dose region with severe pain; interfering with oral intake; limiting self-care ADL)
Measured: At 3 months after radiotherapy
Secondary outcomes (2)
Regional tumor control
Regional tumor control will be measured by clinical H\&N examinations at six weeks and then every three months up to two years. Imaging follow-up includes MRI at 6 weeks and 3 months, FDG-PET CT at 3 months and further CTs every 3 month.
Measured: After 6 weeks, 3 months and every 3 months up to two years
Disease free survival
Clinical H\&N examinations at six weeks and then every three months up to two years, including MRI at 6 weeks and 3 months, FDG-PET CT at 3 months and further CTs every 3 month.
Measured: During treatment and after 6 weeks, 3 months and every 3 months up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start1 Jan 2022
- Primary completion30 Mar 2023 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Dose-finding phase 1 trial with four dose levels and 3+3 design: 12 patients if no DLT occurs up to 24 patients if 1 DLT per dose-level occurs.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160714
- Sponsor's protocol ID
- 081/2021B01
- Acronym
- MRL-02
- Status last verified
- Mar 2021
- First submitted
- 1 Jun 2021
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Response-adaptive Radiation Dose Prescription in HNC Based on MRI - Real-time ADC-guided Response Adaptive Boost in HNC - "Individuelle MR-basierte Dosisverschreibung Bei Kopf-Hals-Tumoren - ADC-basierter Adaptiver Boost"
- ClinicalTrials.gov ID
- NCT05160714
- Acronym / sponsor ID
- MRL-02 / 081/2021B01
- Conditions
- Head and Neck Cancer
- Keywords
- Radiotherapy, MR-guided Radiotherapy, dose-finding study, MR-Linac, ADC-guided response adaptive Boost
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 16 Dec 2021 (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 Phase 1 dose-finding study investigates the maximal tolerated dose for a subsequent phase 2 trial testing MR-guided individualized response-adaptive dose prescription in HNC.
Detailed description
This single-center, non-randomized interventional dose-finding phase I trial evaluates the maximal tolerated boost dose with respect to dose limiting toxicities in patients with locally advanced head and neck squamous cell carcinoma (UICC stage III/IVB) with an indication for a primary radiochemotherapy. The primary aim of the trial is to define the maximal tolerated dose in an ADC-based subvolume using an adaptive SBRT-boost areal. Dose-escalated SBRT boost to ADC-high risk volume will be delivered once a week and is defined according to the the actual imaging immediately performed prior to delivery (real-time adaptive) i.e. it can vary from one week to another and it might also be reduced throughout the course of treatment (response adaptive). In case of complete disappearance of high-risk subvolumes sufficient large enough to boost (<5ml), no further ADC boost but only the floor-boost dose is given. The dose escalation of the ADC-high risk volume boost is graduated in four dose levels of 5x5 Gy, 5x5.5 Gy, 5x6 Gy, 5x6.5 Gy in a classical 3+3 dose-finding design where 3 patients per radiation dose level are enrolled. Primary endpoint is the dose limiting toxicity, any acute and late non-hematologic grade 4 or 5 related to the radiotherapy intervention, ≥ grade 3 CTC v.5. oral mucositis at 3 months after radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose-finding phase 1 trial with four dose levels and 3+3 design: 12 patients if no DLT occurs up to 24 patients if 1 DLT per dose-level occurs.
| Arm | Type | Receives |
|---|---|---|
| Adaptive SBRT Boost | Experimental | Radiation: Real-time ADC-guided response adaptive Boost in HNCDose-escalated SBRT boost to an ADC-based high risk subvolume in HNC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age: older than 18 years
- WHO (ECOG) performance status 0-2
- Histological proven HNC (squamous cell carcinoma)
- HPV negative tumors or high risk HPV positive tumors
- Stage III - IVB HNC of the hypopharynx, oropharynx and oral cavity according to UICC and AJCC guidelines
Key exclusion criteria (12 listed)
- Refusal of the patients to take part in the trial
- Presence of distant metastases (UICC stage IVC)
- HPV positive tumors UICC Stage III with T1/2 N3, despite of smoking status
- Previous radiotherapy in the head and neck region
- Second malignancy that is likely to require treatment during the trial intervention or follow-up period or that, in the opinion of the physician, has a considerable risk of recurrence or metastases within the follow-up period
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 |
|---|---|---|
| Real-time ADC-guided response adaptive Boost in HNC40 Gy in 20 fractions over 5 weeks (Monday to Thursday) to the adjuvant neck, simultaneous integrated boost with 56 Gy in 20 fractions in 5 weeks to the low-risk macroscopic tumor. Once weekly Dose-escalated SBRT adaptive boost to an ADC-based high risk subvolume with graduated dose levels of 5x5 Gy, 5x5.5 Gy, 5x6 Gy, 5x6.5 Gy | Radiation | Adaptive SBRT Boost |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: At 3 months after radiotherapy
Dose limiting toxicity (DLT): any acute and late grade 4 or 5 related to the intervention, ≥ grade 3 CTC v.5. oral mucositis at 3 months after radiotherapy (persistent mucosal ulceration or inflammation in the high dose region with severe pain; interfering with oral intake; limiting self-care ADL)
2 secondary outcomes
Regional tumor control
Time frame: After 6 weeks, 3 months and every 3 months up to two years
Disease free survival
Time frame: During treatment and after 6 weeks, 3 months and every 3 months up to two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Real-time ADC-guided response adaptive Boost in HNC in people with Head and Neck Cancer, run by University Hospital Tuebingen at 1 site in Germany.
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 11 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 1 Feb 2022. 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 Germany. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simon Böke, MD (49 (0) 7071 29 ext. 82165, ro-info@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) (time frame: At 3 months after radiotherapy). 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 Feb 2022.