Comparison of a less intensive post-treatment follow-up strategy with strong patient involvement with conventional tumor follow-up after curative (aimed at complete healing) treatment of head and neck cancer
Summary description of the study
There is an ongoing debate about the optimal frequency and extent of follow-up after curative (aimed at complete healing) treatment in patients with head and neck cancer. These questions are to be addressed by the present study, providing a scientifically based, evidence-based foundation for the current debate. The aim is to develop a less intensive follow-up with increased patient involvement. The study is conducted in a two-arm design, with a control group receiving conventional follow-up and a group with a less intensive, individualized follow-up. Patients in both groups are strongly trained to recognize symptoms of cancer recurrence or second tumors. Assignment to one of the two groups is random. The study lasts for 5 years. For the control group, outpatient visits with clinical examinations are planned every 3 months in the first three years and every 6 months in the last two years. Imaging studies (MRI or CT) are also scheduled at 6 and 18 months after study enrollment, as well as a lung CT examination once a year for 5 years for active and former smokers. For the group with reduced follow-up and increased patient involvement, only two outpatient visits per year are planned. Imaging is not routinely planned in this group. All patients receive a symptom questionnaire with disease signs that may indicate a recurrence of head and neck cancer or a new second tumor (initial paper version, electronic version planned), which they should complete monthly. The responses to this questionnaire from patients in the less intensive follow-up with increased involvement are monitored monthly with feedback and possibly early summons for control.
(BASEC)
Intervention under investigation
In conventional tumor follow-up, outpatient examinations are scheduled at predefined rigid intervals. In the first 3 years after treatment completion, medical controls occur at 3-month intervals, then every 6 months until the end of the 5-year follow-up period. Additionally, imaging studies are scheduled 12 and 24 months after treatment completion. In the experimental, less intensive follow-up strategy with increased involvement, however, medical examinations are planned only semi-annually from the outset, and there are no fixed dates for imaging studies. In total, therefore, significantly fewer examinations are planned. In the latter follow-up strategy, the focus is more on the symptoms of the patients. As part of the study, participants in both groups document their symptoms monthly in a questionnaire with possible disease signs indicating a recurrence of head and neck cancer or a new second tumor. In the less intensive follow-up strategy with increased involvement, the responses to the symptom questionnaires are monitored monthly, and depending on the severity and development of symptoms, a warning is issued and a timely control appointment is organized. During this appointment, it is decided whether additional examinations such as imaging and/or tissue sampling are necessary. This means that overall, fewer examinations are not necessarily conducted, but at times when there is a higher probability that a clinically relevant finding will be found.
Participants are randomly assigned to either the conventional or the experimental individualized follow-up. The disease course is observed for 5 years.
(BASEC)
Disease under investigation
Head and neck cancer most commonly affects the mucous membranes of the oral cavity, pharynx, and larynx. Although modern therapies can cure cancer in many cases, cancer recurs in about 30 - 35% of affected individuals. Smoking and alcohol promote the development of this type of cancer and also lead to an increased risk that after successful treatment a similar cancer occurs at another site in the mucosa of the upper respiratory and digestive tracts. The likelihood of successfully treating a recurrent cancer or a second tumor is higher the earlier the cancer is detected. Therefore, follow-up after completed treatment is undisputed. In addition to the early detection of cancer recurrence or a second tumor, follow-up also serves to address significant side effects of therapy, ensure adequate nutrition, and provide psychological support. In most clinics, this follow-up today consists of regular medical examinations as well as periodic imaging studies (e.g., CT or MRI). However, it is controversial whether these regular examinations play any role in prognosis. Several studies have shown no improvement in overall survival when these examinations were systematically planned. The benefit of these examinations is therefore not scientifically clarified. This is delicate, as such examinations can also yield unclear findings, leading to further, sometimes unnecessary and unpleasant or risky follow-up examinations (e.g., biopsies, examinations under anesthesia, further imaging). For patients, this means a significant psychological burden and high financial costs for the healthcare system. In a preliminary study, we surveyed 100 patients about their preferences regarding the regularity of follow-up examinations. It was found that the vast majority desires regularly scheduled follow-up examinations. More than half (57%) of participants, however, expressed a preference for follow-up strategies with less frequent examinations than the current international standard provides. This circumstance, along with the insufficient scientific data, has led us to conduct the present study. The aim of this study is to compare a new patient-tailored follow-up strategy with the conventional tumor follow-up previously applied. The study aims to find out whether such a de-intensified, individualized follow-up strategy achieves equally good long-term results as the conventional tumor follow-up.
(BASEC)
Eligible for the study are adult patients with cancer of the mucous membranes of the mouth, pharynx, and larynx who: - the therapy was performed with curative intent - the therapy led to a complete disappearance of the tumor, which must be demonstrated approximately 3-6 months after the end of treatment by clinical examination and imaging - consent to participate in the study was documented in writing (BASEC)
Exclusion criteria
Patients cannot be included in the study if: - it is a very early-stage tumor (so-called stage I) - one cancer of the head and neck has already been treated (except for adequately treated precursors of cancer, locally confined basal cell carcinoma, or basal cell carcinoma in stage I) - other concurrently occurring cancers have been diagnosed, except for adequately treated mucosal carcinomas of the oral cavity, pharynx, and larynx, precursors of skin cancer or cervical cancer, locally confined basal cell carcinoma, basal cell carcinoma stage 1, as well as low-risk prostate cancer (BASEC)
Trial sites
Bern, Luzern, Zurich
(BASEC)
Sponsor
Inselspital, Bern University Hospital
(BASEC)
Contact
Contact Person Switzerland
Prof. Dr. med. Roland Giger
+41 31 632 29 31
roland.giger@clutterinsel.chDepartment of ENT, Head and Neck Surgery Inselspital, Bern University Hospital
(BASEC)
General Information
Inselspital, University Hospital Bern
(ICTRP)
Scientific Information
Inselspital, University Hospital Bern
(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Bern
(BASEC)
Date of authorisation
18.10.2022
(BASEC)
ICTRP Trial ID
NCT05388136 (ICTRP)
Official title (approved by ethics committee)
Multicenter randomized trial comparing an individualized de-intensified and conventional follow-up strategy after curative treatment in head and neck cancer (BASEC)
Academic title
Multicenter Randomized Trial Comparing an Individualized De-intensified and Conventional Follow-up Strategy After Curative Treatment in Head and Neck Cancer (ICTRP)
Public title
Trial Comparing Different Follow-up Strategies (ICTRP)
Disease under investigation
Head and Neck Cancer (ICTRP)
Intervention under investigation
Procedure: Conventional follow up schedule with imaging;Procedure: Deintensified follow up schedule without imaging (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion criteria
1. Histopathologically proven invasive HNSCC of the oral cavity (except lip),
oropharynx, hypopharynx or larynx
2. =18 years of age
3. 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.
4. 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.
5. 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).
6. 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
7. Agreement for long term FU (5 years) and all visits are to be performed at the
participating center
8. Written informed consent, signed by the patient and the investigator
Exclusion Criteria
1. Initial clinical stage I and/or M1 HNSCC (according to the UICC / TNM 8th ed.)
2. Nasopharyngeal cancer and carcinoma of unknown primary
3. 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
4. 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.
5. 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.
6. Participation in another study entailing regular medical exams by ENT specialists or
persons involved in the oncological treatment, or regular imaging
7. Pregnant or breastfeeding women
8. Presence of any conditions that potentially hamper compliance with the study
protocol and FU schedule at the participating center (ICTRP)
not available
Primary and secondary end points
Death from any cause (ICTRP)
Death from head and neck cancer;Death from any cancer;First biopsy-proven REC or SPM;General health-related Quality of Life (QoL);Head and neck cancer-specific health-related QoL;Compliance with scheduled follow up assessments;Number of regularly scheduled in-person visits;Number of in-person visits triggered by the recommendation of the PRO;Number of self-referral in-person visits;Number of any in-person visits;Fear of Recurrence (REC);Head and neck caner-specific healthcare utilization (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
University of Bern (ICTRP)
Additional contacts
Roland Giger, Dr. med., Inselspital, University Hospital Bern (ICTRP)
Secondary trial IDs
SNCTP000005198, 1685 DeintensiF (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT05388136 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available