Clinical trial · Interventional
Health and Economic Outcomes of Two Different Follow up Strategies in Effectively Cured Advanced Head and Neck Cancer
NCT02262221CI-TRIAL-00064628HETeCosuspendedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low participant accrual
Summary
Brief summary (as posted)
Randomized, multicenter trial to evaluate the cost-effectiveness of 2 different follows up programs in head and neck cancer survivors. Patients in complete remission at month 6 (+/- 1 month) after curative treatment will be randomized in two arms according to 2 different follow up approaches: Non Intensive Follow up approach (Arm A) with no radiologic evaltuations scheduled, but required only at the occurence of any signs or symptoms and Intensive Follow up approach (Arm B) with scheduled radiologic evaluations.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Scheduled radiologic evaluations | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- ARM A (Non intensive Follow up)
- description
- Follow up consisting of outpatient visits according to the schedule foreseen for single head and neck subsite. At each follow up visit patients will report all new symptoms and they will receive physical and fiberoptic endoscopic head and neck examination. Laboratory tests will be performed once a year. Quality of life questionnaires will be administered to patients every other visit for the first 2 years and then at each visit. A socio-economic questionnaire will be also administered at each visit. Locoregional imaging will be performed within 6 months after radiotherapy end and recommended only at the occurrence of new signs or symptoms. Patients will be contacted by a phone call between visits in order to monitor patient's reported symptoms potentially related to disease recurrence.
- type
- OTHER
- label
- ARM B (Intensive Follow up)
- description
- Intervention foreseen is scheduled radiologic evaluations (CT or MRI scan) and PET scan if patients ≥ 50 years old and with a smoking history ≥ 20 pack year. Follow up outpatient visits will be performed similarly to ARM A, including physical and fiberoptic endoscopic head and neck evaluation and laboratory tests and questionnaires. Locoregional imaging will be requested for all the patients 2 times/year in the first 2 years and 1 time/year in the third and fourth year; PET scan will be requested yearly in the first 3 years. In the first year after RT end, MRI or CT scan will be performed at screening and at sixth month after enrollment, while PET scan will be performed six months after enrollment only in patients ≥50 years and with a smoking history of ≥20 pack/years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Clinical or pathological stage III-IV squamous cell head and neck cancer of oral cavity, oropharynx, larynx or hypopharynx after curative treatment * Oropharyngeal cancer will be enrolled only if HPV negative or HPV positive with a smoking history (i.e. greater than 10 packs/year) * Having already received Radiation Therapy (RT) as curative treatment or in postoperative setting * Patients without evidence of disease within six months after treatment end (first assessment of disease must be performed with radiological imaging for all patients) * Patient randomization must be performed at the sixth month after RT end (+/- 1 month) * Patients having or not received systemic treatment for a curable disease are allowed * Patients not considered suitable for salvage surgery (based on primary tumor characteristics and previous treatments) after hypothetical recurrence are allowed; the choice about feasibility or non feasibility of salvage surgery in case of hypothetical recurrence at T or N level will be made by the multidisciplinary team before randomization (salvage surgery score) * 18 years or older * Informed consent signed Exclusion Criteria: * Patient with primary tumor site: nasopharynx, paranasal sinus, salivary gland or with cancer of unknown primary in head and neck district * Patients unable to comply with the protocol, in the opinion of the investigator * Any other malignancy (except for appropriately treated superficial basal cell skin cancer and surgically cured cervical cancer in situ) unless free of disease for at least five years
References
Publications (1)
- DERIVEDMeregaglia M, Cairns J, Licitra L, Bossi P. The use of intensive radiological assessments in routine surveillance after treatment for head and neck cancer: An economic evaluation. Eur J Cancer. 2018 Apr;93:89-98. doi: 10.1016/j.ejca.2018.01.082. Epub 2018 Mar 20. PMID 29477796