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Идёт набор NCT05354570

A Study of Intensity-Modulated Pleural Radiation Therapy (IMPRINT) in People With Thymic Cancer That Has Spread to the Lining of the Lungs and Chest

Фаза II С лечением Thymic Malignancies Pleural Metastases

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: Intensity-Modulated Pleural Radiation Therapy (IMPRINT).
Кому может быть актуально
Состояния в реестре: Thymic Malignancies, Pleural Metastases. Базовые параметры: 18 лет — 79 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Phase II Study of Hemithoracic Intensity-Modulated Pleural Radiation Therapy (IMPRINT) for Patients With Pleural Metastases From Thymic Malignancies

Обзор

The researchers are doing this study to find out whether hemithoracic intensity-modulated pleural radiation therapy (IMPRINT) is a safe treatment that causes few or mild side effects in people with pleural metastases from thymic malignancies. The researchers will also look at whether hemithoracic IMPRINT is effective against participants' cancer.

Вмешательства

  • Лучевая терапия Intensity-Modulated Pleural Radiation Therapy (IMPRINT)
    Radiation therapy will be administered over approximately 6 weeks at 50.4 Gy in 28 fractions, including an optional dose-painting SIB to gross residual disease up to 60 Gy while respecting normal tissue constraints.

Первичные конечные точки

  • assess the rate of radiation pneumonitis [Срок оценки: 2 years]
Вторичные конечные точки (1)
  • progression-free survival (PFS) [Срок оценки: 12 month]

Критерии участия

Критерии включения

  • Provide written informed consent to participate on the study
  • Patients must have a pathologically confirmed diagnosis of thymic malignancy. Thymic carcinoma is allowed.
  • Patients must have radiologic or pathologic evidence of pleural metastases. Patients may have de novo stage IVA or recurrent disease in the pleura. Gross disease in the fissure is allowed if resected.
  • No evidence of extrathoracic metastatic disease or contralateral pleural/pericardial disease.
  • Patient age ≥ 18 years but ≤ 80 years at the time of consent
  • Karnofsky performance status ≥ 80%
  • Preoperative or Postoperative Pulmonary Function Tests: DLCO > 40% predicted (corrected for Hgb) and FEV1 ≥ 35% (corrected for Hgb)
  • Glomerular filtration rate (GFR): ≥50 mL/min/1.73 m2 (must be calculated using estimated creatinine clearance (CrCl) by the Cockcroft-Gault (C-G) equation (Nephron 1976;16:31-41): CrCl (mL/min) = \[140 - age (years)\] x weight (kg) \[x 0.85 for female patients\] 72 x serum creatinine (mg / dL) ° In cases of concern about decreased renal function and potential high radiation dose to the kidneys, an optional nuclear medicine kidney function scan may be performed prior to radiation therapy to determine the functional contribution of each kidney.

Критерии исключения

  • Continuous oxygen use
  • Patients with an acute flare of myasthenia gravis requiring addition of new medication in the past 6 months
  • Prior nephrectomy on the contralateral side of the pleural metastases
  • Prior thoracic radiation therapy preventing hemithoracic pleural IMRT. Prior thymic bed radiation is allowed. Prior pleural SBRT is allowed.
  • Patients undergoing extrapleural pneumonectomy. Other surgical resection approaches of the pleural nodules (ex: P/D, debulking/metastasectomy) are allowed. Surgical resection of the primary thymic tumor is allowed.
  • Acute congestive heart failure requiring hospitalization within the past 30 days.
  • COPD requiring chronic oral steroid therapy of > 10 mg prednisone daily or equivalent at the time of registration. Inhaled corticosteroids are allowed
  • Unstable angina requiring hospitalization and/or transmural myocardial infarction within the last 3 months
  • History of interstitial lung disease
  • Pregnant or lactating women
  • Men or women not using effective contraception

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 7 центров
  • Memorial Sloan Kettering Basking Ridge (Limited protocol activities) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (Limited protocol activities) — Middletown
  • Memorial Sloan Kettering Bergen (Limited protocol activities) — Montvale
  • Memorial Sloan Kettering Suffolk - Commack (Limited protocol activities) — Commack
  • Memorial Sloan Kettering Westchester (Limited protocol activities) — Harrison
  • Memorial Sloan Kettering Cancer Center — New York
  • Memorial Sloan Kettering Nassau (Limited protocol activities) — Rockville Centre

Идентификаторы

NCT: NCT05354570 · 22-098

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗