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Идёт набор NCT05808920

The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck

Наблюдательное Head and Neck Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Molecular Analyses.
Кому может быть актуально
Состояния в реестре: Head and Neck Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Великобритания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The RESCUE study is a combined retrospective and prospective multicentre cohort study investigating the survival and functional outcomes in patients undergoing salvage surgery for recurrent, residual, and new primary head and neck squamous cell carcinoma (SCC). Additionally, the RESCUE study will contain an exploratory molecular analysis of consenting patients to assess the relationship between cancer genomics, previous radiotherapy, and recurrence in head and neck cancer.

Подробное описание

The RESCUE study is a combined retrospective and prospective multicentre cohort study investigating the survival and functional outcomes in patients undergoing salvage surgery for recurrent, residual, and new primary head and neck squamous cell carcinoma (SCC).

Additionally, the RESCUE study will contain an exploratory molecular analysis of consenting patients to assess the relationship between cancer genomics, previous radiotherapy, and recurrence in head and neck cancer.

The aim of this study is to determine the survival, functional and quality of life outcomes of patients undergoing all salvage surgery for recurrent, residual and new primary head and neck SCC, and to establish the genetic architecture and clonal evolution H\&N SCC after previous treatment for radiotherapy cancer.

Вмешательства

  • Генная терапия Molecular Analyses
    Nucleic acid extraction, protein analysis. Tumour tissue, blood and saliva samples collected.

Первичные конечные точки

  • Ascertain the 2-year disease-free survival post salvage surgery [Срок оценки: Study duration is 3 years to include 1 year recruitment period. Active follow-up for patients is up to 2 years.]
Вторичные конечные точки (12)
  • Define the 2- and 5-year overall and disease specific survival in retrospectively identified patients [Срок оценки: Study duration is 3 years to include 1 year recruitment period. Active follow-up for prospective patients is up to 2 years. Follow-up for retrospective patients is up to 5 years.]
  • Define the 2 year overall and disease specific survival in prospectively identified patients [Срок оценки: Study duration is 3 years to include 1 year recruitment period. Active follow-up for patients is up to 2 years.]
  • Report on gross functional outcomes by documenting rates of gastrostomy and tracheostomy dependence at 1-year post-salvage surgery. [Срок оценки: Study duration is 3 years with up to 2 years follow-up in prospective and up to 5 years follow-up in retrospective patients. Functional outcomes will be measured from the date of surgery.]
  • For the prospective cohort assess the overall quality-of-life outcomes pre-operatively and at 6- and 12-months post-surgery using validated questionnaires. [Срок оценки: University of Washing Quality of life questionnaire distributed pre-operatively, 6 months and 12 months.]
  • For the prospective cohort assess the swallow-related quality-of-life outcomes at pre-operatively and at 6- and 12-months post-surgery using validated questionnaires. [Срок оценки: MD Anderson Dysphagia Inventory distributed pre-operatively, 6 months and 12 months.]
  • Estimate the rates of close and involved surgical margins across all surgical salvage procedures [Срок оценки: Through study completion, expected duration of 3 years]
  • Determine the impact of close and involved margins on overall survival outcomes [Срок оценки: Through study completion, expected duration of 3 years]
  • Determine the impact of close and involved margins on disease-free survival outcomes [Срок оценки: Through study completion, expected duration of 3 years]
  • Determine the impact of close and involved margins on disease-specific survival outcomes [Срок оценки: Through study completion, expected duration of 3 years]
  • Establish the rates of super-selective, selective and modified/ radical salvage neck dissection in clinically N0 and N+ necks [Срок оценки: Through study completion, expected duration of 3 years]
  • Ascertain how the extent of salvage neck dissection influences overall survival outcomes. [Срок оценки: Through study completion, expected duration of 3 years]
  • Ascertain how the extent of salvage neck dissection influences disease-free survival outcomes. [Срок оценки: Through study completion, expected duration of 3 years]

Критерии участия

Критерии включения

  • Aged over 18
  • Previous H\&N SCC treated with radiotherapy with or without chemotherapy
  • Local or regionally recurrent, residual, or new primary SCC of the oropharynx, oral cavity, larynx, and hypopharynx
  • Ability to give informed consent for biological sample collection (molecular analysis study only)

Критерии исключения

  • Nasopharyngeal and cutaneous SCC of the H\&N
  • Thyroid, salivary gland, and non-squamous cell H\&N cancers
  • Presence of distant metastasis (M1) or surgically inoperable T4b tumours

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Великобритания · 9 центров
  • University Hospitals Derby and Burton — Derby
  • NHS Lothian — Edinburgh
  • Western General, Greater Glasgow and Clyde — Glasgow
  • Aintree Hospital — Liverpool
  • Head and Neck Unit, Royal Marsden Hospital — London
  • Northwick Park — London
  • Oxford University Hospital NHS Foundation Trust — Oxford
  • Poole Hospital, University Hospitals Dorset — Poole
  • … и ещё 1 центр

Идентификаторы

NCT: NCT05808920 · CCR 5752

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗