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Идёт набор NCT05187091

The SWOAR Trial Sparing of Swallowing and Aspiration Related Organs at Risk & Submandibular Gland With Intensity Modulated Radiotherapy Versus Standard IMRT in Head and Neck Squamous Cell Carcinomas

Фаза III С лечением Head and Neck Neoplasms Swallowing Sparing IMRT

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: Swallowing and submandibular sparing IMRT, Standard IMRT with medical CRT/RT, Cisplatine.
Кому может быть актуально
Состояния в реестре: Head and Neck Neoplasms, Swallowing Sparing IMRT. Базовые параметры: 18 лет — 70 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
Индия
Следующий шаг
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Официальное название

The SWOAR Trial: A Phase III Trial Evaluating Sparing of Swallowing and Aspiration Related Organs at Risk & Submandibular Gland With Intensity Modulated Radiotherapy Versus Standard IMRT in Head and Neck Squamous Cell Carcinomas

Обзор

The aim of SWOAR TRIAL is to test sparing of Dysphagia/ Aspiration risk structures (DARS) and contra lateral submandibular gland by IMRT. HNSCC of the oropharynx, larynx and the hypopharynx treated with radical concurrent chemoradiotherapy or radiotherapy will be included in the trial. Patients will be randomized to SWOAR IMRT or standard IMRT. Swallowing function will be evaluated the MD Anderson Dysphagia Inventory (MDADI) scoring. Difference in the mean composite score of MDADI, a patient-reported outcome, at 6 months post radiotherapy is the primary outcome of the trial. Secondary Objectives include longitudinal assessment of aspiration prevention as evaluated by FEES by the 8 point penetration-aspiration score. Swallowing function, will be assessed by using the MDADI at baseline, at completion of CRT/RT, 3, 6, 12, and 24 months. Assessment of acute and late toxicity assessed at baseline, weekly during radiotherapy and then at 3, 6, 12, and 24 months post treatment as per RTOG and LENT SOMA score, respectively. Treatment outcomes will be assessed in terms of loco-regional tumor recurrence and overall survival, assessed at follow-up visits 3, 6, 12, and 24 months post treatment and then annually until 5 years post treatment.

Вмешательства

  • Лучевая терапия Swallowing and submandibular sparing IMRT
    Standard IMRT with radical CRT/RT with additional sparing of dysphagia-aspiration related structures \& submandibular gland sparing by SWOAR-IMRT
  • Лучевая терапия Standard IMRT with medical CRT/RT
    standard IMRT with medical CRT/RT
  • Препарат Cisplatine
    Cisplatin will be given during the radiation at a dose of 40 mg/m2 weekly to a cumulative dose of at least 200 mg/m2 in case of margin positive disease

Первичные конечные точки

  • Change in swallowing function post radiotherapy [Срок оценки: 6 months]
Вторичные конечные точки (9)
  • Swallowing assessment [Срок оценки: longitudinal assessment till 2 years]
  • Aspiration assessment [Срок оценки: longitudinal assessment till 2 years]
  • Acute Toxicity [Срок оценки: longitudinal assessment till 2 years]
  • Late Toxicity assessment by RTOG [Срок оценки: longitudinal assessment till 2 years]
  • Late Toxicity assessment by LENT SOMA [Срок оценки: longitudinal assessment till 2 years]
  • Treatment outcome: Loco-regional tumor control [Срок оценки: 2 years]
  • Treatment outcome: Overall survival [Срок оценки: 2 years]
  • Quality of life assessment: EORTC QLQ C-30 [Срок оценки: longitudinal assessment till 2 years]
  • Quality of life assessment: EORTC QLQ HN35 [Срок оценки: longitudinal assessment till 2 years]

Критерии участия

Критерии включения

  • Aged 18 or above and less than 70 years
  • Patient undergoing radiotherapy for HNSCC of the Oropharynx or Larynx or Hypopharynx.
  • Stage T1-4, N0-3, M0 disease with histologically confirmed squamous cell carcinoma requiring bilateral neck radiotherapy and where sparing of contra lateral or one submandibular gland is possible
  • Radiotherapy with concomitant chemotherapy (unless contraindicated) is the planned treatment
  • Karnofsky performance score greater or equal 70
  • Available to attend long term follow- up;
  • Ability to complete the MD Anderson Dysphagia Inventory (MDADI) and EORTC quality of life questionnaires English or Hindi Version.
  • Willingness to undergo FEES.
  • Written informed consent for treatment.
  • Available to attend long term follow- up

Критерии исключения

  • Early Carcinoma Glottis (T1-T2, N0M0)
  • Metastatic disease.
  • Previous radiotherapy to the head and neck region
  • Lateralised tumours, requiring unilateral irradiation
  • Patients requiring radiation to both submandibular glands
  • Evidence of pre-existing swallowing dysfunction (not related to HNC);
  • Major head and neck surgery (excluding biopsies/tonsillectomy);
  • Tracheostomy placement
  • Previous or concurrent illness, which in the investigator's opinion would interfere with completion of therapy, trial assessments or follow-up
  • Any invasive malignancy within previous 2 years (other than non melanomatous skin carcinoma or cervical carcinoma in situ).

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Индия · 1 центр
  • Nci, Aiims — Jhajjar

Идентификаторы

NCT: NCT05187091 · 2021/05/043810

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗