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Health and Economic Outcomes of Two Different Follow up Strategies in Effectively Cured Advanced Head and Neck Cancer
Conditions
Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Intervention
Name: Scheduled radiologic evaluations
Type: Other
Overall Status
Recruiting
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).
- 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
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
- 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
Locations
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Milano, MI, Italy
Policlino S. Orsola-Maplighi
Status: Recruiting
Contact: Paolo Bossi, MD - +39 022390 - paolo.bossi@istitutotumori.mi.it
Bologna, Italy
Spedali Civili di Brescia
Status: Not yet recruiting
Contact: Claudio Marchetti, MD
Brescia, Italy
Azienda Ospedaliera Universitaria Careggi
Status: Not yet recruiting
Contact: Piero Nicolai, MD - pieronicolai@virgilio.it
Firenze, Italy
Istituto Nazionale per la ricerca sul cancro
Status: Not yet recruiting
Contact: Massimo Squadrelli, MD - m.squadrelli@gmail.com
Genova, Italy
Istituto Europeo di Oncologia
Status: Not yet recruiting
Contact: Renzo Corvò, MD - renzo.corvo@unige.it
Milano, Italy
Policlinico di Modena
Status: Not yet recruiting
Contact: Mohsen Ansarin, MD - mohssen.ansarin@ieo.it
Modena, Italy
Istituto Nazionale Tumori IRCCS - Fondazione Pascale
Status: Not yet recruiting
Contact: Livio Presutti, MD - presutti.livio@policlinico.mo.it
Napoli, Italy
Ospedale di Parma
Status: Not yet recruiting
Contact: Franco Ionna, MD - f.ionna@istitutotumori.na.it
Parma, Italy
Fondazione IRCCS Policlinico San Matteo
Status: Recruiting
Contact: Enrico Sesenna, MD - enrico.sesenna@unipr.it
Pavia, Italy
Azienda Ospedaliera Santa Maria degli Angeli
Status: Not yet recruiting
Contact: Marco Bennazzo, MD - m.benazzo@smatteo.pv.it
Pordenone, Italy
Istituto Nazionale Tumori Regina Elena
Status: Not yet recruiting
Contact: Giueseppe Grando, MD - grando@libero.it
Roma, Italy
Ospedale di Trento
Status: Recruiting
Contact: Giuseppe Spriano, MD - orl@ifo.it
Trento, Italy
Istituto Oncologico della Svizzera Italiana
Status: Not yet recruiting
Contact: Cesare Grandi, MD - cesare.grandi@apss.tn.it
Bellinzona, Switzerland
CHUV - Centre hospitalier universitaire vaudois
Status: Not yet recruiting
Contact: Antonella Richetti, MD - antonella.richetti@eoc.ch
Lausanne, Switzerland
Status: Not yet recruiting
Contact: Christian Simon, MD - Christian.Simon@chuv.ch
Start Date
May 2014
Completion Date
April 2017
Sponsors
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Source
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page