Status:
SUSPENDED
Health and Economic Outcomes of Two Different Follow up Strategies in Effectively Cured Advanced Head and Neck Cancer
Lead Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborating Sponsors:
Bocconi University
University of Pavia
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 cur...
Detailed Description
The choice about timing of follow visits for each patient will be performed before randomization and will be tailored to the single patient in accordance to NCCN and AIOCC guidelines following this sc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT02262221
Start Date
June 1 2014
End Date
December 1 2023
Last Update
March 13 2023
Active Locations (15)
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1
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Milan, MI, Italy, 20133
2
Policlino S. Orsola-Maplighi
Bologna, Italy, 40138
3
Spedali Civili di Brescia
Brescia, Italy, 25123
4
Azienda Ospedaliera Universitaria Careggi
Florence, Italy, 50134