Trial Title:
Health and Economic Outcomes of Two Different Follow up Strategies in Effectively Cured Advanced Head and Neck Cancer
NCT ID:
NCT02262221
Condition:
Head and Neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Suspended
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Scheduled radiologic evaluations
Description:
Scheduled radiologic evaluations (CT or MRI scan) and PET scan in the case that patiets
are ≥ 50 years old and with a smokink history ≥ 20 pack year
Arm group label:
ARM B (Intensive Follow up)
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 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.
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 scheduling:
- Oral Cavity cancer: every 2 months for the 1st year, every 3 months in the 2nd year,
every 4 months in the 3rd year and every 6 months in the 4th and 5th year
- Oropharyngeal and laryngeal cancer: every 3 months for the 1st and the 2nd year,
every 4 months in the 3rd year and every 6 months in the 4th and 5th year
- Hypopharyngeal cancer: every 3 months for the 1st and the 2nd year, every 6 months
from the 3rd to the 5th year
Patients deemed to be in complete remission at month 6 (+/- 1 month) after curative
treatment will be randomized in two follow up arms:
ARM A (Non intensive): follow up according to NCCN guidelines, consisting of outpatient
visits according to the schedule foreseen for single head and neck subsite. At each
follow up visit the patients will report all new symptoms and they will receive both
physical and fiberoptic endoscopic head and neck examination.
Laboratory tests (complete blood count, renal, hepatic and thyroid function) will be
performed once a year. Quality of life questionnaire (EuroQol 5D5L, EORTC QLQ C-30 and
HN35) will be administered to patients every other visit for the first 2 years and then
at each visit. During each visit, a socio-economic questionnaire will be also
administered. Locoregional imaging will be performed within 6 months after treatment end
and then will be recommended only on the occurrence of new signs or symptoms. Only
patients in this arm will be contacted by a phone call between visits in order to monitor
patient's reported symptoms which could be potentially related to disease recurrence.
ARM B (Intensive): 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. Radiological imaging with PET will be customized according to smoking history
being performed in subjects >50 years and with a smoking history of > 20 pack/years.
Randomization will be stratified according to site of primary disease, smoking history (>
10pack years) and likelihood of feasibility or non feasibility of salvage surgery if a
recurrence at T/N level would emerge (salvage surgery feasibility).
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Address:
City:
Milano
Zip:
20133
Country:
Italy
Facility:
Name:
Policlino S. Orsola-Maplighi
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Facility:
Name:
Spedali Civili di Brescia
Address:
City:
Brescia
Zip:
25123
Country:
Italy
Facility:
Name:
Azienda Ospedaliera Universitaria Careggi
Address:
City:
Firenze
Zip:
50134
Country:
Italy
Facility:
Name:
Istituto Nazionale per la ricerca sul cancro
Address:
City:
Genova
Zip:
16132
Country:
Italy
Facility:
Name:
Istituto Europeo di Oncologia
Address:
City:
Milano
Zip:
20141
Country:
Italy
Facility:
Name:
Policlinico di Modena
Address:
City:
Modena
Zip:
41124
Country:
Italy
Facility:
Name:
Istituto Nazionale Tumori IRCCS - Fondazione Pascale
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Facility:
Name:
Ospedale di Parma
Address:
City:
Parma
Zip:
43126
Country:
Italy
Facility:
Name:
Fondazione IRCCS Policlinico San Matteo
Address:
City:
Pavia
Zip:
27100
Country:
Italy
Facility:
Name:
Azienda Ospedaliera Santa Maria degli Angeli
Address:
City:
Pordenone
Zip:
33170
Country:
Italy
Facility:
Name:
Istituto Nazionale Tumori Regina Elena
Address:
City:
Roma
Zip:
00144
Country:
Italy
Facility:
Name:
Ospedale di Trento
Address:
City:
Trento
Zip:
38122
Country:
Italy
Facility:
Name:
Istituto Oncologico della Svizzera Italiana
Address:
City:
Bellinzona
Zip:
6500
Country:
Switzerland
Facility:
Name:
CHUV - Centre hospitalier universitaire vaudois
Address:
City:
Lausanne
Zip:
CH-1011
Country:
Switzerland
Start date:
June 2014
Completion date:
December 2023
Lead sponsor:
Agency:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Agency class:
Other
Collaborator:
Agency:
Bocconi University
Agency class:
Other
Collaborator:
Agency:
University of Pavia
Agency class:
Other
Source:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02262221
