ISRCTN13709798进行中（未招募）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)
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 698
研究概览
简要总结
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38987693/ (added 11/07/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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