Superiority Trial Evaluating Digitalized Information Media for Patients With Advanced Sarcomas Receiving Systemic Treatment.

Официальное название

Phase 3 Superiority Trial Evaluating the Benefit of Dematerialized Information Media for Patients With Advanced Sarcomas Receiving Systemic Treatment for Metastatic or Locally Advanced Disease.

Обзор

ePPS-2202 is a study designed to evaluate the benefits of a dematerialised personalised care plan (PCP) compared to standard information/PCP for patients with advanced sarcomas receiving systemic treatment. Participants will be randomised to an experimental group or a control group. Patients in the experimental group will receive the dematerialised PCP in addition to the standard PCP while patients in the control group will receive the standard PCP alone. All patients will be followed until the end of second-line treatment, the start of a new line of treatment, or until the 24-month follow-up.

Подробное описание

ePPS-2202 is a phase 3, randomised,open-label, controlled, multicentre interventional study, designed to evaluate the benefits of a dematerialised personalised care plan (PCP) compared to standard information/PCP in patients with metastatic of locally advanced sarcomas with indication of a systemic treatment with pazopanib, tracbectedine, eribuline, ifosfamide or dacarbazine monotherapy.

Participants will be randomised to the experimental arm or the control arm. Patients in the experimental arm will receive the dematerialised PCP in addition to the standard PCP while patients in the control arm will receive the standard PCP alone.

All patients will be followed until the end of second-line treatment, the start of a new line of treatment, or until the 24-month follow-up.

The main analysis will compare the proportion of patients in each arm who experience at least one severe adverse event during the first 3 months of second-line treatment. Adverse events will be considered severe if they are graded 3 or higher according to NCI-CTCAE v5.0.

Вмешательства

• Другое Dematerialized Personalized Care Plan (ePCP)
  Post-treatment support with standard support combined with dematerialized support

Первичные конечные точки

• Severe toxicity in the first 3 months of treatment [Срок оценки: 3 months]

Вторичные конечные точки (7)

• Progression-free survival (PFS) [Срок оценки: 24 months]
• Overall survival (OS) [Срок оценки: 24 months]
• Severe toxicity [Срок оценки: 24 months]
• Nature of severe AEs [Срок оценки: 24 months]
• AEs leading to hospitalization [Срок оценки: 24 months]
• Survival weighted by quality of life [Срок оценки: 24 months]
• Quality of life assessed by EORTC QLQ-C30 questionnaire [Срок оценки: 3 months]

Критерии участия

Критерии включения

• Sarcomas of soft tissues or viscera ;
• Inoperable metastatic or locally advanced disease ;
• Indication for systemic treatment with pazopanib, trabectedine, eribulin, ifosfamide or dacarbazine monotherapy ;
• Patient covered by French social security ;
• Written, signed, informed consent ;

Критерии исключения

• Prior inclusion in ePPS trial for a prior systemic treatment ;
• Poor understanding of French ;
• Difficulty accessing a computer ;
• Pregnant or nursing woman ;
• Person deprived of liberty or under guardianship ;
• Impossibility of undergoing medical follow-up for geographical, social or psychological reasons.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 11 центров

• Centre Léon Bérard — Lyon
• CHU Jean Minjoz — Besançon
• Centre Eugène Marquis — Rennes
• Centre Paul Strauss — Strasbourg
• Centre Oscar Lambret — Lille
• CHU de Poitiers — Poitiers
• Institut Claudius Regaud — Toulouse
• Institut de Cancérologie de l'Ouest — Saint-Herblain
• … и ещё 3 центра

Идентификаторы

NCT: NCT06211257 · ePPS-2202 · 2023-A00984-41

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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