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Идёт набор NCT05033288

Comparing Carbon Ion Therapy, Surgery, and Proton Therapy for Management of Pelvic Sarcomas Involving the Bone

— Наблюдательное Bone Sarcoma Chondrosarcoma Chordoma Ewing Sarcoma of Bone

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: Electronic Health Record Review, Quality-of-Life Assessment.
Кому может быть актуально
Состояния в реестре: Bone Sarcoma, Chondrosarcoma, Chordoma, Ewing Sarcoma of Bone. Базовые параметры: от 15 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
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Официальное название

Prospective Comparative Effectiveness Trial of Carbon Ion Therapy, Surgery, and Proton Therapy for the Management of Pelvic Sarcomas (Soft Tissue/Bone) Involving the Bone

Обзор

This study compares carbon ion therapy, surgery, and proton therapy to determine if one has better disease control and fewer side effects. There are three types of radiation treatment used for pelvic bone sarcomas: surgery with or without photon/proton therapy, proton therapy alone, and carbon ion therapy alone. The purpose of this study is to compare quality of life among patients treated for pelvic bone sarcomas across the world, and to determine if carbon ion therapy improves quality of life compared to surgery and disease control compared with proton therapy.

Подробное описание

PRIMARY OBJECTIVES:

I. Demonstrate whether carbon ion therapy provides improved patient reported health related quality of life (PRO-HRQOL) outcomes and less significant toxicities compared with surgery.

II. Demonstrate whether carbon ion therapy provides improved local control versus proton therapy.

OUTLINE:

Patients complete quality of life questionnaires over 20 minutes at baseline (before any therapy), 2-4 and 5-9 months after completion of therapy, and then annually for up to 5 years. Patients' medical records are also reviewed.

Вмешательства

  • Другое Electronic Health Record Review
    Medical records are reviewed
  • Другое Quality-of-Life Assessment
    Complete quality of life questionnaires

Первичные конечные точки

  • Average difference in change of functional quality of life (QOL) [Срок оценки: Baseline (pre-treatment) to 1 year after completion of treatment]
  • Proportion of patients experiencing local control [Срок оценки: Up to 5 years after completion of treatment]
  • Progression-free survival - local control [Срок оценки: Up to 5 years after completion of treatment]
  • Progression-free survival - regional control [Срок оценки: Up to 5 years after completion of treatment]
  • Progression-free survival - distant control [Срок оценки: Up to 5 years after completion of treatment]
  • Overall survival - local control [Срок оценки: Up to 5 years after completion of treatment]
  • Overall survival - regional control [Срок оценки: Up to 5 years after completion of treatment]
  • Overall survival - distant control [Срок оценки: Up to 5 years after completion of treatment]
Вторичные конечные точки (3)
  • Secondary and exploratory analyses on toxicity data [Срок оценки: Up to 5 years after completion of treatment]
  • Secondary and exploratory analyses on dose volume histogram (DVH) data [Срок оценки: Up to 5 years after completion of treatment]
  • Dose volume histogram [Срок оценки: Up to 5 years after completion of treatment]

Критерии участия

Критерии включения

  • Males and females >= 15 years of age
  • Newly diagnosed, histologic confirmation of pelvic chordoma, chondrosarcoma, osteosarcoma, Ewing sarcoma with bone involvement, rhabdomyosarcoma (RMS) with bone involvement or non-RMS soft tissue sarcoma with bone involvement
  • No evidence of distant sarcoma metastases as determined by clinical examination and any form of imaging
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 2
  • Patients capable of childbearing must agree to use adequate contraception
  • Ability to complete questionnaire(s) by themselves or with assistance
  • Ability to provide written informed consent
  • Chemotherapy per institutional guidelines is allowed

Критерии исключения

  • Patients receiving palliative treatment
  • Recurrent disease
  • Males and females < 15 years of age
  • Previous radiation therapy to the site of the sarcoma or area surrounding it such that it would be partially or completely encompassed by the radiation volume needed to treat the current sarcoma. In other words, treatment on this study would require re-irradiation of tissues
  • Patients with distant sarcoma metastases
  • Benign pelvic bone histologies
  • Any of the following:
  • Pregnant women
  • Nursing women
  • Men or women of childbearing potential who are unwilling to employ adequate contraception

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 3 центра
  • Mayo Clinic in Arizona — Scottsdale
  • Mayo Clinic in Florida — Jacksonville
  • Mayo Clinic in Rochester — Rochester

Идентификаторы

NCT: NCT05033288 · MC210709 · NCI-2021-08847 · MC210709 · 21-004080 · ROF2181

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗