Набор скоро начнётся NCT07242911

Study on Efficacy and Safety of VMAT Technique With Local Dose Escalation for Unresectable Pancreatic Cancer

— Наблюдательное Ppancreatic 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: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Ppancreatic Cancer. Базовые параметры: 18 лет — 76 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: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The goal of this observational study is to learn about the efficacy and safety of the Volumetric Modulated Arc Therapy (VMAT) dose sculpting technique combined with different radiotherapy doses (local dose escalation vs. conventional dose) in patients with unresectable pancreatic cancer, with a focus on survival outcomes, tumor response, and toxic/adverse effects. The main question it aims to answer is:Does the VMAT dose sculpting technique combined with local dose escalation radiotherapy (total dose 60-65Gy) improve overall survival (OS), progression-free survival (PFS), and tumor response rate while maintaining acceptable safety (i.e., manageable toxic/adverse effects) compared to conventional dose radiotherapy (total dose 45-50.4Gy) in patients with unresectable pancreatic cancer? Participants who have already received VMAT (as part of their regular medical care for unresectable pancreatic cancer) at Chifeng City Cancer Hospital from February 2018 to May 2026 will be divided into two groups based on the radiotherapy dose they received: the study group (local dose escalation, 60-65Gy) and the control group (conventional dose, 45-50.4Gy). All participants will undergo follow-up via phone calls, WeChat, and outpatient re-examinations to collect data on their survival status (OS, PFS), tumor response (assessed by RECIST 1.1 criteria), and toxic/adverse effects (assessed by RTOG for radiation injury and CTCAE 4.0 for chemotherapy-related reactions) until the completion of outcome evaluation.

Первичные конечные точки

Overall Survival (OS) in Patients with Unresectable Pancreatic Cancer Treated with VMAT Radiotherapy [Срок оценки: Up to 5 years (from February 2018 to May 2026, with follow-up until outcome evaluation completion).]

Вторичные конечные точки (3)

Progression-Free Survival (PFS) in Patients with Unresectable Pancreatic Cancer Treated with VMAT Radiotherapy [Срок оценки: Up to 5 years (from February 2018 to May 2026, with follow-up until outcome evaluation completion).]
Objective Response Rate (ORR) in Patients with Unresectable Pancreatic Cancer Treated with VMAT Radiotherapy [Срок оценки: Up to 5 years (from February 2018 to May 2026, with follow-up until outcome evaluation completion).]
Incidence of Chemoradiotherapy Toxicity and Adverse Effects in Patients with Unresectable Pancreatic Cancer Treated with VMAT Radiotherap [Срок оценки: Up to 5 years (from February 2018 to May 2026, with follow-up until outcome evaluation completion).]

Критерии участия

Критерии включения

Patients with locally advanced pancreatic cancer confirmed by pathological diagnosis or PET-CT.
Patients who refuse surgery or are inoperable.
No history of radiotherapy.
Aged 18-76 years with a performance status score of 0-1.