Trial Comparing Different Follow-up Strategies

NCT05388136 | Terminated DMC

• 2 other identifiers: 1685 DeintensiFSNCTP000005198
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief 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). 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

Conditions

Head and Neck Cancer

Keywords

Follow up schedule; Patient reported outcomes; Head and neck cancer

Outcome Measures

Primary Outcomes (1)

• 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).

  Up to 5 years

Secondary Outcomes (12)

• Death from head and neck cancer

  Up to 5 years

• Death from any cancer

  Up to 5 years

• First biopsy-proven REC or SPM

  Up to 5 years

• General health-related Quality of Life (QoL)

  Up to 5 years

• Head and neck cancer-specific health-related QoL

  Up to 5 years

Other Outcomes (3)

• Type and grading of specific treatment-related adverse events and outcome

  Up to 5 years

• Characteristics of REC/ secondary primary malignancy (SPM)

  Up to 5 years

• Adherence to electronical signs/symptom monitoring and visits that are triggered by the PRO

  Up to 5 years

Study Arms (2)

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.

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.

Procedure: Deintensified follow up schedule without imaging

Interventions

Conventional follow up schedule with imaging PROCEDURE

Frequent of follow up visit and imaging

Control Arm

Deintensified follow up schedule without imaging PROCEDURE

Less intense follow up visit without imaging

Individualized Deintensified Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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+).
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Bern: collaborator

Study Sites (3)

Inselspital, University Hospital Bern

Bern, 3010, Switzerland

Location

Luzerner Kantonsspital, Klinik für Hals-,Nasen-,Ohren-und Gesichtschirurgie

Lucerne, 6000, Switzerland

Location

Universitätsspital Zürich, Klinik für Ohren-, Nasen-, Hals- und Gesichtschirurgie

Zurich, 8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 40380278 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Roland Giger, Dr. med.

  Inselspital, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 24, 2022
• Study Start: October 12, 2022
• Primary Completion: May 16, 2025
• Study Completion: May 16, 2025
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (3)