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

NCT02262221 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2023-03-13

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Bocconi University

    collaborator OTHER

  • University of Pavia

    collaborator OTHER

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    lead OTHER

Principal Investigators

  • Lisa Licitra, MD · Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2020-07-31
Completion
2023-12-31

Countries

  • Italy
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02262221 on ClinicalTrials.gov