Head and Neck CancerDeintensiFNCT05388136
Trial Comparing Different Follow-up Strategies
A study testing Conventional follow up schedule with imaging and Deintensified follow up schedule without imaging in people with Head and Neck Cancer, run by Insel Gruppe AG, University Hospital Bern at 3 sites in Switzerland.
Trial summary
There is an ongoing debate about the optimal duration, frequency and extent of follow-up (FU) after treatment with curative intent (aimed at complete cure) in patients with head and neck cancer (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?
- Conventional follow up schedule with imaging and Deintensified follow up schedule without imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 12 Oct 2022to 16 May 2025
- Phase
- Interventional
- 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
- Histopathologically proven invasive HNSCC of the oral cavity (except lip), oropharynx, hypopharynx or larynx
- ≥18 years of age
- In non-surgically treated HNSCC: clinical/radiological stage II-IV (excluding M1) according to the UICC / TNM 8th ed. In surgically treated HNSCC: pathological stage II-IV (excluding M1) according to the UICC / TNM 8th ed.
- Treatment with curative intent, regardless of treatment modality (mono- or multimodal), and FU planned at the participating study center.
- Remark: Patients with one synchronous HNSCC of the oral cavity, oropharynx, hypopharynx and larynx, all treated with curative intent and all in complete remission are eligible. Synchronous tumor must have a less advanced stage than the index tumor used for stratification or in case of equal stage, the synchronous tumor must be the tumor with the better prognostic. (Rules: Better to worse prognostic: Larynx > Oropharynx > Oral cavity > Hypopharynx.) The modality of the treatment must be the same as for the index tumor or less intense.
- Radiological confirmation of complete remission of disease and no SPM from the 3rd to 6th month after treatment for all stages (minimal demanded imaging: head and neck (H\&N) MRI or H\&N CT scan and CT scan covering chest to pelvis (with contrast if not contraindicated); or preferable whole-body 18FDG-PET/CT or PET/MRI for patients with ≥T3 and/or N+).
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- Note: Patients with positive or equivocal imaging/clinical findings are allowed if the tumor is ruled out by multidisciplinary tumor board decision (e.g. as a consequence of biopsy and/or multiple imaging).
- Clinical confirmation of complete remission of disease through H\&N examination including endoscopy of the pharynx and larynx at the time of enrolment, that is 6 months (+/- 4 weeks) after the last HNSCC treatment
- Agreement for long term FU (5 years) and all visits are to be performed at the participating center
- Written informed consent, signed by the patient and the investigator
Who cannot join
- Initial clinical stage I and/or M1 HNSCC (according to the UICC / TNM 8th ed.)
- Nasopharyngeal cancer and carcinoma of unknown primary
- Any other previously treated HNC (including parotid and thyroid gland cancer) except for curatively and adequately treated cutaneous carcinoma in-situ, basal cell carcinoma and locally confined T1 squamous cell carcinoma of the skin without any sign of tumor recurrence at the time of screening
- Any other synchronous malignancy except for one curatively and adequately treated HNSCC of the oral cavity, oropharynx, hypopharynx and larynx, basal cell carcinoma, locally confined T1 squamous cell carcinoma of the skin, low-risk prostate cancer, carcinoma in-situ of the skin or uterine cervix without any sign of tumor recurrence at the time of screening.
- Any other metachronous malignancy within the last 5 years except for curatively and adequately treated basal cell carcinoma, locally confined T1 squamous cell carcinoma of the skin, low-risk prostate cancer, carcinoma in-situ of the skin or uterine cervix without any sign of tumor recurrence at the time of screening.
- Participation in another study entailing regular medical exams by ENT specialists or persons involved in the oncological treatment, or regular imaging
- Pregnant or breastfeeding women
- Presence of any conditions that potentially hamper compliance with the study protocol and FU schedule at the participating center
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
Inselspital, University Hospital Bern
Bern, 3010
Luzerner Kantonsspital, Klinik für Hals-,Nasen-,Ohren-und Gesichtschirurgie
Lucerne, 6000
Universitätsspital Zürich, Klinik für Ohren-, Nasen-, Hals- und Gesichtschirurgie
Zurich, 8091
About this study
Official title: Multicenter Randomized Trial Comparing an Individualized De-intensified and Conventional Follow-up Strategy After Curative Treatment in Head and Neck Cancer
There is an ongoing debate about the optimal duration, frequency and extent of follow-up (FU) after treatment with curative intent (aimed at complete cure) in patients with head and neck cancer (HNC). The present study aims to answer these questions and thus provide a scientifically sound, evidence-based basis for the current debate. The aim is to develop a more personalized follow-up strategy with patient involvement. The study contains an internal pilot phase and a main phase.
Pilot phase, started in Oct 2022:
Read more
Sample size: 20 participants Duration: 2 years (12 months recruitment, 12 months FU) Planned First-Participant-In: Oct 2022 Planned Last-Participant-Out: Oct/2024
Main study, not yet started awaiting for funding :
Sample size: 550 participants Estimated duration: 8 years (recruitment period: 3 years, FU period: 5 years) Planned First-Participant-In: Q4/2023 Planned Last-Participant-Out: Q4/2031
Read the detailed description
The study will be conducted in a two-arm design, with a control group receiving conventional aftercare and a group receiving less intensive, individualized aftercare. Patients in both groups will be strongly sensitized or trained to the symptoms of cancer recurrence or second tumor. Assignment to one of the two groups is randomized. The study starts with a internal pilot phase of one year aiming to proof the feasibility of recruitment and participant's adherence to the randomized FU scheme. When the pilot phase proved feasibility showed positive result, we will conduct the main study which lasts 5 years for all participants.
For the control group (standard follow-up), medical check-ups are performed at 3-monthly intervals in the first 3 years after completion of therapy, then 4 - 6-monthly until completion of the follow-up period after 5 years. In addition, imaging is scheduled 12 and 24 months after the end of therapy. In addition, imaging examinations (magnetic resonance imaging or computed tomography) are scheduled 6 and 18 months after study inclusion. For active and former smokers, a CT scan of the lungs is scheduled at 30, 42, and 54 months.
In the experimental group (individualized, deintensified follow-up), medical examinations are scheduled only every six months from the beginning and there are no fixed appointments for imaging. In the latter follow-up strategy, the focus is more on the symptoms of the patients.
In the study, participants in both groups document their symptoms monthly in a patient reported-outcome (PRO) questionnaire with possible signs of disease indicating a recurrence of head and neck cancer or a new secondary tumor. For the pilot study, a paper PRO will be used, while in the main study a electronic PRO is planned. In the less intensive, individualized follow-up strategy, the answers to the symptom questionnaires are checked monthly and, depending on the severity and development of the symptoms, a warning is given and a timely follow-up appointment is organized. During this appointment, it will be decided if additional examinations such as imaging and/or tissue sampling are necessary. This means that fewer examinations are not necessarily performed overall, but at times when there is an increased likelihood that a clinically relevant finding will also be found.
Disease progression will be monitored for 5 years.
- Conditions
- Head and Neck Cancer
- Being tested
- Conventional follow up schedule with imaging, Deintensified follow up schedule without imaging
- Keywords
- Follow up schedule, Patient reported outcomes, Head and neck cancer
- 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.
Conventional follow up schedule with imagingProcedure or surgery
Frequent of follow up visit and imaging
Deintensified follow up schedule without imagingProcedure or surgery
Less intense follow up visit without imaging
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | Conventional (standard) FU entails frequent clinical exams and routine imaging (17 visits including a visit at randomization, plus 4 or 7 imaging depending on smoking habits of the participant) during 5 years of FU.
PRO with rating scale is to be completed monthly by the participant, but no alert will be generated and the participating center will not arrange urgent appointment, except in case of self-referral for any reasons. Receives: Procedure: Conventional follow up schedule with imaging |
| Individualized Deintensified Arm | Experimental | Individualized de-intensified FU entailing less frequent clinical exams and no routine imaging (11 visits including visit at randomization) without any routinely planned imaging during 5 years of FU.
PRO with rating scale is to be completed monthly by the participant. The PRO result will trigger an alert to the participant and to the site in conditions indicating possible REC/SPM. In case of possible (recurrence or secondary primary malignancy) REC/SPM, an 'open urgent appointment' will be arranged for the participant by the participating centers' team within 2 weeks. Receives: Procedure: Deintensified follow up schedule without imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death from any cause
Death from any cause is defined as the time interval between the date of randomization and the date of death up to 5 years i.e. patients who are not known to have died will be censored at the date of the last time point at which they were known to be alive (quantified by the 5-year RMST).
Measured: Up to 5 years
Secondary outcomes (12)
Death from head and neck cancer
Time to HNC-specific death
Measured: Up to 5 years
Death from any cancer
Time to cancer-specific death
Measured: Up to 5 years
First biopsy-proven REC or SPM
Based on participating centers' assessment according to the Union for International Cancer Control (UICC)/ tumor, nodes, metastasis (TNM) 8th ed.
Measured: Up to 5 years
General health-related Quality of Life (QoL)
As assessed every 6 months over 5 years by means of the European Organisation for Research and Treatment of Cancer, Core Quality of Life of Cancer Patients (EORTC QLQ-C30)a scale of 1 - 4 are used to assess each condition and a higher scores mean a worse outcome
Measured: Up to 5 years
Head and neck cancer-specific health-related QoL
As assessed every 6 months over 5 years by means of the European Organisation for Research and Treatment of Cancer, Head and Neck Cancer Module (EORTC QLQ-HN43), a scale of 1 - 4 are used to assess each condition and a higher scores mean a worse outcome
Measured: Up to 5 years
Compliance with scheduled follow up assessments
Defined as percentage of scheduled follow up visits attended
Measured: Up to 5 years
Number of regularly scheduled in-person visits
Measured: Up to 5 years
Number of in-person visits triggered by the recommendation of the PRO
Measured: Up to 5 years
Number of self-referral in-person visits
Measured: Up to 5 years
Number of any in-person visits
Measured: Up to 5 years
Fear of Recurrence (REC)
Assessed by a rating scale (0 - 4) question within the PRO questionnaire, and a higher scores mean a worse outcome
Measured: Up to 5 years
Head and neck caner-specific healthcare utilization
Defined as any regular and emergency visits to any physician, hospitalizations and treatments for HNC-related reasons
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start12 Oct 2022
- Primary completion16 May 2025
- Study completion16 May 2025
Why it stopped: Lack of funding
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 Head and Neck CancerStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Sponsor
- Investigators
- Roland Giger, Dr. med., Principal investigator, Inselspital, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388136
- Sponsor's protocol ID
- 1685 DeintensiF
- Other IDs
- SNCTP000005198
- Acronym
- DeintensiF
- Status last verified
- Feb 2026
- First submitted
- 18 May 2022
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mueller M, Visini M, Mueller SA, Stadler T, Rajan GP, Morand GB, Hool SL, Schanne DH, Balermpas P, Limacher A, Chan S, Trelle S, Elicin O, Giger R. DeintensiF: Standard versus individualized deintensified follow-up after curative treatment in head and neck cancer: protocol of a randomized pilot study. Pilot Feasibility Stud. 2025 May 16;11(1):69. doi: 10.1186/s40814-025-01651-3.
PubMed 40380278
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Trial Comparing an Individualized De-intensified and Conventional Follow-up Strategy After Curative Treatment in Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT05388136
- Acronym / sponsor ID
- DeintensiF / 1685 DeintensiF
- Conditions
- Head and Neck Cancer
- Keywords
- Follow up schedule, Patient reported outcomes, Head and neck cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 16 May 2025 (actual)
- Study completion
- 16 May 2025 (actual)
- First posted
- 24 May 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.
There is an ongoing debate about the optimal duration, frequency and extent of follow-up (FU) after treatment with curative intent (aimed at complete cure) in patients with head and neck cancer (HNC). The present study aims to answer these questions and thus provide a scientifically sound, evidence-based basis for the current debate. The aim is to develop a more personalized follow-up strategy with patient involvement. The study contains an internal pilot phase and a main phase.
Pilot phase, started in Oct 2022:
Sample size: 20 participants Duration: 2 years (12 months recruitment, 12 months FU) Planned First-Participant-In: Oct 2022 Planned Last-Participant-Out: Oct/2024
Main study, not yet started awaiting for funding :
Sample size: 550 participants Estimated duration: 8 years (recruitment period: 3 years, FU period: 5 years) Planned First-Participant-In: Q4/2023 Planned Last-Participant-Out: Q4/2031
Detailed description
The study will be conducted in a two-arm design, with a control group receiving conventional aftercare and a group receiving less intensive, individualized aftercare. Patients in both groups will be strongly sensitized or trained to the symptoms of cancer recurrence or second tumor. Assignment to one of the two groups is randomized. The study starts with a internal pilot phase of one year aiming to proof the feasibility of recruitment and participant's adherence to the randomized FU scheme. When the pilot phase proved feasibility showed positive result, we will conduct the main study which lasts 5 years for all participants.
For the control group (standard follow-up), medical check-ups are performed at 3-monthly intervals in the first 3 years after completion of therapy, then 4 - 6-monthly until completion of the follow-up period after 5 years. In addition, imaging is scheduled 12 and 24 months after the end of therapy. In addition, imaging examinations (magnetic resonance imaging or computed tomography) are scheduled 6 and 18 months after study inclusion. For active and former smokers, a CT scan of the lungs is scheduled at 30, 42, and 54 months.
In the experimental group (individualized, deintensified follow-up), medical examinations are scheduled only every six months from the beginning and there are no fixed appointments for imaging. In the latter follow-up strategy, the focus is more on the symptoms of the patients.
In the study, participants in both groups document their symptoms monthly in a patient reported-outcome (PRO) questionnaire with possible signs of disease indicating a recurrence of head and neck cancer or a new secondary tumor. For the pilot study, a paper PRO will be used, while in the main study a electronic PRO is planned. In the less intensive, individualized follow-up strategy, the answers to the symptom questionnaires are checked monthly and, depending on the severity and development of the symptoms, a warning is given and a timely follow-up appointment is organized. During this appointment, it will be decided if additional examinations such as imaging and/or tissue sampling are necessary. This means that fewer examinations are not necessarily performed overall, but at times when there is an increased likelihood that a clinically relevant finding will also be found.
Disease progression will be monitored for 5 years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Procedure: Conventional follow up schedule with imagingConventional (standard) FU entails frequent clinical exams and routine imaging (17 visits including a visit at randomization, plus 4 or 7 imaging depending on smoking habits of the participant) during 5 years of FU. PRO with rating scale is to be completed monthly by the participant, but no alert will be generated and the participating center will not arrange urgent appointment, except in case of self-referral for any reasons. |
| Individualized Deintensified Arm | Experimental | Procedure: Deintensified follow up schedule without imagingIndividualized de-intensified FU entailing less frequent clinical exams and no routine imaging (11 visits including visit at randomization) without any routinely planned imaging during 5 years of FU. PRO with rating scale is to be completed monthly by the participant. The PRO result will trigger an alert to the participant and to the site in conditions indicating possible REC/SPM. In case of possible (recurrence or secondary primary malignancy) REC/SPM, an 'open urgent appointment' will be arranged for the participant by the participating centers' team within 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histopathologically proven invasive HNSCC of the oral cavity (except lip), oropharynx, hypopharynx or larynx
- ≥18 years of age
- In non-surgically treated HNSCC: clinical/radiological stage II-IV (excluding M1) according to the UICC / TNM 8th ed. In surgically treated HNSCC: pathological stage II-IV (excluding M1) according to the UICC / TNM 8th ed.
- Treatment with curative intent, regardless of treatment modality (mono- or multimodal), and FU planned at the participating study center.
- Remark: Patients with one synchronous HNSCC of the oral cavity, oropharynx, hypopharynx and larynx, all treated with curative intent and all in complete remission are eligible. Synchronous tumor must have a less advanced stage than the index tumor used for stratification or in case of equal stage, the synchronous tumor must be the tumor with the better prognostic. (Rules: Better to worse prognostic: Larynx > Oropharynx > Oral cavity > Hypopharynx.) The modality of the treatment must be the same as for the index tumor or less intense.
Key exclusion criteria (8 listed)
- Initial clinical stage I and/or M1 HNSCC (according to the UICC / TNM 8th ed.)
- Nasopharyngeal cancer and carcinoma of unknown primary
- Any other previously treated HNC (including parotid and thyroid gland cancer) except for curatively and adequately treated cutaneous carcinoma in-situ, basal cell carcinoma and locally confined T1 squamous cell carcinoma of the skin without any sign of tumor recurrence at the time of screening
- Any other synchronous malignancy except for one curatively and adequately treated HNSCC of the oral cavity, oropharynx, hypopharynx and larynx, basal cell carcinoma, locally confined T1 squamous cell carcinoma of the skin, low-risk prostate cancer, carcinoma in-situ of the skin or uterine cervix without any sign of tumor recurrence at the time of screening.
- Any other metachronous malignancy within the last 5 years except for curatively and adequately treated basal cell carcinoma, locally confined T1 squamous cell carcinoma of the skin, low-risk prostate cancer, carcinoma in-situ of the skin or uterine cervix without any sign of tumor recurrence at the time of screening.
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 |
|---|---|---|
| Conventional follow up schedule with imagingFrequent of follow up visit and imaging | Procedure or surgery | Control Arm |
| Deintensified follow up schedule without imagingLess intense follow up visit without imaging | Procedure or surgery | Individualized Deintensified Arm |
Primary outcome
Death from any cause
Time frame: Up to 5 years
Death from any cause is defined as the time interval between the date of randomization and the date of death up to 5 years i.e. patients who are not known to have died will be censored at the date of the last time point at which they were known to be alive (quantified by the 5-year RMST).
12 secondary outcomes
Death from head and neck cancer
Time frame: Up to 5 years
Death from any cancer
Time frame: Up to 5 years
First biopsy-proven REC or SPM
Time frame: Up to 5 years
General health-related Quality of Life (QoL)
Time frame: Up to 5 years
Head and neck cancer-specific health-related QoL
Time frame: Up to 5 years
Compliance with scheduled follow up assessments
Time frame: Up to 5 years
Number of regularly scheduled in-person visits
Time frame: Up to 5 years
Number of in-person visits triggered by the recommendation of the PRO
Time frame: Up to 5 years
Number of self-referral in-person visits
Time frame: Up to 5 years
Number of any in-person visits
Time frame: Up to 5 years
Fear of Recurrence (REC)
Time frame: Up to 5 years
Head and neck caner-specific healthcare utilization
Time frame: Up to 5 years
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Derived from this study: PubMed 40380278Mueller M, Visini M, Mueller SA, Stadler T, Rajan GP, Morand GB, Hool SL, Schanne DH, Balermpas P, Limacher A, Chan S, Trelle S, Elicin O, Giger R. DeintensiF: Standard versus individualized deintensified follow-up after curative treatment in head and neck cancer: protocol of a randomized pilot study. Pilot Feasibility Stud. 2025 May 16;11(1):69. doi: 10.1186/s40814-025-01651-3.
- 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. This study is not recruiting at the moment.
Roland Giger, Dr. med. principal investigator
Inselspital, University Hospital Bern
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional follow up schedule with imaging and Deintensified follow up schedule without imaging in people with Head and Neck Cancer, run by Insel Gruppe AG, University Hospital Bern at 3 sites in Switzerland.
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 8 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: stopped early, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. 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?
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death from any cause (time frame: Up to 5 years). 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 NCT05388136, 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 2 Mar 2026; AzTrials last refreshed its copy on 30 Oct 2026.