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Health and Economic Outcomes of Two Different Follow up Strategies in Effectively Cured Advanced Head and Neck Cancer (HETeCo)

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ClinicalTrials.gov Identifier: NCT02262221
Recruitment Status : Unknown
Verified June 2016 by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.
Recruitment status was:  Recruiting
First Posted : October 13, 2014
Last Update Posted : June 30, 2016
Sponsor:
Collaborators:
Bocconi University
University of Pavia
Information provided by (Responsible Party):
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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 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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Other: Scheduled radiologic evaluations Phase 2

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Health and Economic Outcomes of Two Different Follow up Strategies in Effectively Cured Advanced Head and Neck Cancer
Study Start Date : June 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: ARM A (Non intensive Follow up)
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)
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.
Other: Scheduled radiologic evaluations
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Evaluation of the percentage of potentially salvageable recurrences or second primaries [ Time Frame: 3 years ]
    To evaluate the percentage of potentially salvageable recurrences or second primaries in both groups of follow up approach.

  2. Assessment of the cause-specific survival [ Time Frame: 3 years ]
    To assess the cause-specific survival (CSS).

  3. Assessment of the OS of patients recurring [ Time Frame: 3 years ]
    To assess the overall survival (OS) of patients recurring in both groups of follow up approach.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02262221


Contacts
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Contact: Paolo Bossi, MD +39 022390 ext 2765 paolo.bossi@istitutotumori.mi.it
Contact: Roberta Granata, MD +39 022390 ext 2765 roberta.granata@istitutotumori.miit

Locations
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Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Recruiting
Milano, MI, Italy, 20133
Contact: Paolo Bossi, MD    +39 022390 ext 2765    paolo.bossi@istitutotumori.mi.it   
Contact: Roberta Granata, MD    +39 022390 ext 2765    roberta.granata@istitutotumori.mi.it   
Policlino S. Orsola-Maplighi Recruiting
Bologna, Italy, 40138
Contact: Claudio Marchetti, MD         
Contact: Achille Tarsitano, MD       achilletarsitano@gmail.com   
Spedali Civili di Brescia Recruiting
Brescia, Italy, 25123
Contact: Piero Nicolai, MD       pieronicolai@virgilio.it   
Azienda Ospedaliera Universitaria Careggi Not yet recruiting
Firenze, Italy, 50134
Contact: Massimo Squadrelli, MD       m.squadrelli@gmail.com   
Istituto Nazionale per la ricerca sul cancro Recruiting
Genova, Italy, 16132
Contact: Renzo Corvò, MD       renzo.corvo@unige.it   
Istituto Europeo di Oncologia Recruiting
Milano, Italy, 20141
Contact: Mohsen Ansarin, MD       mohssen.ansarin@ieo.it   
Policlinico di Modena Not yet recruiting
Modena, Italy, 41124
Contact: Livio Presutti, MD       presutti.livio@policlinico.mo.it   
Contact: Gabriele Molteni, MD       gabriele.molteni@yahoo.it   
Istituto Nazionale Tumori IRCCS - Fondazione Pascale Recruiting
Napoli, Italy, 80131
Contact: Franco Ionna, MD       f.ionna@istitutotumori.na.it   
Ospedale di Parma Recruiting
Parma, Italy, 43126
Contact: Enrico Sesenna, MD       enrico.sesenna@unipr.it   
Contact: Andrea Ferri, MD       a.ferri@libero.it   
Fondazione IRCCS Policlinico San Matteo Recruiting
Pavia, Italy, 27100
Contact: Marco Bennazzo, MD       m.benazzo@smatteo.pv.it   
Azienda Ospedaliera Santa Maria degli Angeli Recruiting
Pordenone, Italy, 33170
Contact: Giueseppe Grando, MD       grando@libero.it   
Istituto Nazionale Tumori Regina Elena Recruiting
Roma, Italy, 00144
Contact: Giuseppe Spriano, MD       orl@ifo.it   
Contact: Barbara Pichi, MD       pichi@ifo.it   
Ospedale di Trento Recruiting
Trento, Italy, 38122
Contact: Cesare Grandi, MD       cesare.grandi@apss.tn.it   
Switzerland
Istituto Oncologico della Svizzera Italiana Recruiting
Bellinzona, Switzerland, 6500
Contact: Antonella Richetti, MD       antonella.richetti@eoc.ch   
CHUV - Centre hospitalier universitaire vaudois Not yet recruiting
Lausanne, Switzerland, CH-1011
Contact: Christian Simon, MD       Christian.Simon@chuv.ch   
Contact: Yan Monnier, MD       yan.monnier@chuv.ch   
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Bocconi University
University of Pavia
Investigators
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Principal Investigator: Lisa Licitra, MD Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT02262221     History of Changes
Other Study ID Numbers: INT 48/14
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: June 30, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study results will be shared trough pubblications, abstracts and posters

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms