Head and Neck CancerHETeCoNCT02262221
Health and Economic Outcomes of Two Different Follow up Strategies in Effectively Cured Advanced Head and Neck Cancer
A study testing Scheduled radiologic evaluations in people with Head and Neck Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 15 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Scheduled radiologic evaluations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Jun 2014to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
Italy13 sites
Policlino S. Orsola-Maplighi
Bologna, 40138
Spedali Civili di Brescia
Brescia, 25123
Azienda Ospedaliera Universitaria Careggi
Florence, 50134
Istituto Nazionale per la ricerca sul cancro
Genova, 16132
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Milan, MI, 20133
Istituto Europeo di Oncologia
Milan, 20141
Policlinico di Modena
Modena, 41124
Istituto Nazionale Tumori IRCCS - Fondazione Pascale
Naples, 80131
Ospedale di Parma
Parma, 43126
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Azienda Ospedaliera Santa Maria degli Angeli
Pordenone, 33170
Istituto Nazionale Tumori Regina Elena
Roma, 00144
Ospedale di Trento
Trento, 38122
Switzerland2 sites
Istituto Oncologico della Svizzera Italiana
Bellinzona, 6500
CHUV - Centre hospitalier universitaire vaudois
Lausanne, CH-1011
About this study
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.
Read the 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).
- Conditions
- Head and Neck Cancer
- Being tested
- Scheduled radiologic evaluations
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scheduled radiologic evaluationsOther
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
| Study group | Role | What they receive |
|---|---|---|
| ARM A (Non intensive Follow up) | No intervention | 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. |
| ARM B (Intensive Follow up) | Other | 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. Receives: Other: Scheduled radiologic evaluations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the most cost-effective follow up strategy
To evaluate the most cost-effective follow up strategy by comparing health consequences and costs of the two alternative follow-up strategies.
Measured: 3 years
Secondary outcomes (3)
Evaluation of the percentage of potentially salvageable recurrences or second primaries
To evaluate the percentage of potentially salvageable recurrences or second primaries in both groups of follow up approach.
Measured: 3 years
Assessment of the cause-specific survival
To assess the cause-specific survival (CSS).
Measured: 3 years
Assessment of the OS of patients recurring
To assess the overall survival (OS) of patients recurring in both groups of follow up approach.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2020
- Study completionDec 2023 (estimated)
Why it stopped: Low participant accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Bocconi University, University of Pavia
- Responsible party
- Sponsor
- Investigators
- Lisa Licitra, MD, Principal investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02262221
- Sponsor's protocol ID
- INT 48/14
- Acronym
- HETeCo
- Status last verified
- Mar 2023
- First submitted
- 6 Oct 2014
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Study results will be shared trough pubblications, abstracts and posters
Publications
Meregaglia 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.
PubMed 29477796
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health and Economic Outcomes of Two Different Follow up Strategies in Effectively Cured Advanced Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT02262221
- Acronym / sponsor ID
- HETeCo / INT 48/14
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Low participant accrual
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Collaborators
- Bocconi University, University of Pavia
- Study start
- Jun 2014
- Primary completion
- Jul 2020 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 13 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM A (Non intensive Follow up) | No intervention | –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. |
| ARM B (Intensive Follow up) | Other | Other: Scheduled radiologic evaluationsIntervention 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scheduled radiologic evaluationsScheduled 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 | Other | ARM B (Intensive Follow up) |
Primary outcome
Evaluation of the most cost-effective follow up strategy
Time frame: 3 years
To evaluate the most cost-effective follow up strategy by comparing health consequences and costs of the two alternative follow-up strategies.
3 secondary outcomes
Evaluation of the percentage of potentially salvageable recurrences or second primaries
Time frame: 3 years
Assessment of the cause-specific survival
Time frame: 3 years
Assessment of the OS of patients recurring
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Derived from this study: PubMed 29477796Meregaglia 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.
- Individual participant dataSharing planned: Yes. Study results will be shared trough pubblications, abstracts and posters
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Licitra, MD principal investigator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scheduled radiologic evaluations in people with Head and Neck Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Italy, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the most cost-effective follow up strategy (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02262221, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.