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Clinical Trials/ISRCTN13709798
ISRCTN13709798Active, not recruiting未知

A PET-CT guided, symptom-based, patient-initiated surveillance versus clinical follow-up in head neck cancer (PETNECK 2)- Feasibility Study followed by randomised controlled trial (RCT)

niversity of Birmingham0 sites698 target enrollmentStarted: November 3, 2021Last updated:
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Conditions

Trial Snapshot

Phase
未知
Status
Active, not recruiting
Enrollment
698
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38987693/ (added 11/07/2024)

Study Design

Study Type
Interventional

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •Current participant inclusion criteria as of 19/01/2024:
  • •Feasibility :
  • •1. Histological or cytological confirmation of oral, laryngeal, hypopharyngeal or oropharyngeal squamous cell carcinoma
  • •2. Patients at least 6 months post completion of curative-intent treatment by any modality (surgery, radiation or combination treatments), with no clinical symptoms or signs of loco-regional or distant metastasis
  • •3. Patients must be aged 18 years or older
  • •4. Provision of informed consent prior to any study-specific procedures
  • •Inclusion Criteria – Registration Stage
  • •For inclusion in the registration stage of the RCT, patients should fulfil the following criteria:
  • •1. Histological or cytological confirmation of oral, laryngeal, nasopharyngeal, hypopharyngeal or oropharyngeal squamous cell carcinoma
  • •2. Patient at 6 – 14 months post curative intent treatment by any modality (surgery, radiation or combination treatments), with no clinical symptoms or signs of loco-regional or distant
  • •3. Provision of informed consent prior to any study-specific procedures
  • •4. The patient must be aged 18 years or over
  • •5. Willingness to comply with the protocol for the duration of the study
  • •Inclusion Criteria – Randomisation Stage
  • •For inclusion in the RCT, patients should fulfil the following criteria:
  • •1. Patient with no clinical symptoms or signs of loco-regional or distant metastasis or no
  • •evidence of recurrent cancer
  • •2. Patient at 11-14 months post curative intent treatment by any modality (surgery, radiation or combination treatments)
  • •3. Patient willing to comply with the protocol for the duration of the study
  • •Previous participant inclusion criteria as of 13/10/2023 to 19/01/2024:
  • •1. Histological or cytological confirmation of oral, laryngeal, hypopharyngeal or oropharyngeal squamous cell carcinoma
  • •2. Patients at least 6 months post completion of curative-intent treatment by any modality (surgery, radiation or combination treatments), with no clinical symptoms or signs of loco-regional or distant metastasis
  • •3. Patients must be aged 18 years or older
  • •4. Provision of informed consent prior to any study-specific procedures
  • •Previous participant inclusion criteria:
  • •1. Histological or cytological confirmation of oral, laryngeal, hypopharyngeal or oropharyngeal squamous cell carcinoma
  • •2. Patients at one year after curative-intent treatment by any modality (surgery, radiation or combination treatments), with no clinical symptoms or signs of loco-regional or distant metastasis
  • •3. Patients must be aged 18 years or older
  • •4. Provision of informed consent prior to any study-specific procedures

Exclusion Criteria

  • •Current participant exclusion criteria as of 19/01/2024:
  • •Feasibility :
  • •1. Patients with non-squamous cell carcinoma tumours, or those from sites other than those stated in the inclusion criteria
  • •2. Patients who are pregnant
  • •3. Patients with clinical symptoms or signs of loco-regional or distant metastasis
  • •4. Any patient already enrolled in a clinical trial where scheduled follow-up is a requirement of that trial protocol
  • •5. Significant concern by patient or clinician regarding the ability of patient to undertake patient-initiated follow-up (must record in the Screening/Enrolment Log)
  • •Exclusion Criteria – Registration Stage
  • •Patients should not be registered in the RCT if any of the following apply:
  • •1. Patient with non-squamous cell carcinoma tumours, or those from sites other than those stated above
  • •2. Patient who is pregnant
  • •3. Patient with clinical symptoms or signs or radiological evidence of loco-regional or distant
  • •4. Patient with confirmed unknown primary cancer
  • •5. Patient already enrolled in a head and neck clinical trial where scheduled follow up is part of the trial protocol
  • •6. Significant concern by patient or clinician regarding the ability of patient to undertake patient initiated follow up (must record in the Screening/Enrolment Log)
  • •Exclusion Criteria – Randomisation Stage
  • •Patients should not be randomised in the RCT if any of the following apply:
  • •1. Patient who has relapsed or presented with cancer recurrence since registration
  • •2. Patient who is pregnant
  • •3. Any patient enrolled in a head and neck clinical trial where scheduled follow up is part of the trial protocol
  • •4. Significant concern by patient or clinician regarding the ability of patient to undertake patient initiated follow up
  • •Previous participant exclusion criteria as of 13/10/2023:
  • •1. Patients with non-squamous cell carcinoma tumours, or those from sites other than those stated in the inclusion criteria
  • •2. Patients who are pregnant
  • •3. Patients with clinical symptoms or signs of loco-regional or distant metastasis
  • •4. Any patient already enrolled in a clinical trial where scheduled follow-up is a requirement of that trial protocol
  • •5. Significant concern by patient or clinician regarding the ability of patient to undertake patient-initiated follow-up (must record in the Screening/Enrolment Log)
  • •Previous participant exclusion criteria:
  • •1. Patients with non-squamous cell carcinoma tumours, or those from sites other than those stated above
  • •2. Patients who are pregnant
  • •3. Patients with clinical symptoms or signs or radiological evidence of loco-regional or distant metastasis
  • •4. Any patient already enrolled in a clinical trial where scheduled follow-up is part of that trial protocol

Investigators

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