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

NCT02262221 | Suspended

• 1 other identifier: INT 48/14
• Study Type: interventional
• Target: 330
• Locations: 2 countries
• Sites: 15

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years

Secondary Outcomes (3)

• Evaluation of the percentage of potentially salvageable recurrences or second primaries

  3 years

• Assessment of the cause-specific survival

  3 years

• Assessment of the OS of patients recurring

  3 years

Study Arms (2)

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.

Other: Scheduled radiologic evaluations

Interventions

Scheduled radiologic evaluations OTHER

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 B (Intensive Follow up)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• years or older
• Informed consent signed

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead
• Bocconi University: collaborator
• University of Pavia: collaborator

Study Sites (15)

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Milan, MI, 20133, Italy

Location

Policlino S. Orsola-Maplighi

Bologna, 40138, Italy

Location

Spedali Civili di Brescia

Brescia, 25123, Italy

Location

Azienda Ospedaliera Universitaria Careggi

Florence, 50134, Italy

Location

Istituto Nazionale per la ricerca sul cancro

Genova, 16132, Italy

Location

Istituto Europeo di Oncologia

Milan, 20141, Italy

Location

Policlinico di Modena

Modena, 41124, Italy

Location

Istituto Nazionale Tumori IRCCS - Fondazione Pascale

Napoli, 80131, Italy

Location

Ospedale di Parma

Parma, 43126, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Azienda Ospedaliera Santa Maria degli Angeli

Pordenone, 33170, Italy

Location

Istituto Nazionale Tumori Regina Elena

Roma, 00144, Italy

Location

Ospedale di Trento

Trento, 38122, Italy

Location

Istituto Oncologico della Svizzera Italiana

Bellinzona, 6500, Switzerland

Location

CHUV - Centre hospitalier universitaire vaudois

Lausanne, CH-1011, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 29477796 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Lisa Licitra, MD

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2014
• First Posted: October 13, 2014
• Study Start: June 1, 2014
• Primary Completion: July 1, 2020
• Study Completion: December 1, 2023
• Last Updated: March 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

IT (13); CH (2)