Идёт набор NCT04861558

Efficacy of Hyperthermic Intraperitoneal Chemotherapy

Фаза III С лечением Colorectal Cancer Peritoneal 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: 5Fluorouracil, Irinotecan, Oxaliplatin.
Кому может быть актуально: Состояния в реестре: Colorectal Cancer, Peritoneal 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: Индия, Швеция
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

EFFIPEC - Efficacy of Hyperthermic Intraperitoneal Chemotherapy, Single-arm Phase I Study, Followed by an Open-label, Randomized, Controlled Registry-based Phase III Trial

Обзор

A dose titration study and a combined superiority registry-based open-label randomized control trial is planned to answer the trial objectives. The study will be registry-based to allow simpler and more comprehensive follow-up. Patients with colorectal cancer will be treated with cytoreductive surgery (CRS) together with either standard oxaliplatin HIPEC (the control for the efficacy study) or oxaliplatin/irinotecan HIPEC in combination with 5-FU 24-hour EPIC. The 5-FU will be administered postoperatively when the abdomen is completely sutured. The drug is divided equally into 2 injections of 200 ml each and injected through two abdominal drains that are clamped for 16 hours. For dose escalation, the titration groups (á 3 or 6 patients) are followed for 30 days postoperatively after which the Data Monitoring Committee (DMC) will determine whether or not to increase the 5-FU dose for the following group of patients. To study efficacy, randomization is performed intraoperatively. The patient is followed up postoperatively for a total of 3 years for the secondary endpoints which may be extended by the study committee to 5 years. Since the trial is registry based, the long-term follow-up does not require separate eCRF evaluations. These evaluations can be automatically retrieved from the registry - both recurrence data, quality of life, and morbidity data. Some specific eCRF evaluations will be integrated as a separate study part of the HIPEC registry, such as inclusion/exclusion criteria and adverse event reporting (including SUSAR reporting).

Подробное описание

Not detailed description entered.

Вмешательства

Препарат 5Fluorouracil
Injection of 250-850 mg/m2.
Препарат Irinotecan
Injection of 360 mg/m2
Препарат Oxaliplatin
Injection of 460 mg/m2

Первичные конечные точки

Recurrence-free survival [Срок оценки: 24 months after treatment]

Вторичные конечные точки (4)

Overall survival [Срок оценки: 5 years after treatment]
Recurrence-free survival [Срок оценки: 5 years after treatment]
Postoperative complication rate [Срок оценки: Within 30 days after treatment]
Patient evaluations of quality of life [Срок оценки: 3 years after treatment]

Критерии участия

Критерии включения

Provision of written informed consent prior to any study specific procedures.
ECOG Performance Status Score 0,1 or 2 alternatively Karnofsky 60-100
Adequate kidney, liver, bone marrow function according to laboratory tests
For females of childbearing potential, a negative pregnancy test must be documented
≥ 18 years old and ≤78 years old
Colorectal cancer with peritoneal metastases +/- liver metastases (maximum 3)
Concomitant resectable pulmonary metastases are allowed
All patients deemed eligible for CRS and HIPEC according to clinical routine management during a HIPEC multidisciplinary board at each respective hospital can be included.

Критерии исключения

Previous severe toxicity/allergic reactions to systemic chemotherapy agents oxaliplatin or irinotecan or 5-fluorouracil
Unable to tolerate intensified HIPEC treatment due to comorbidity
Metastasis other than peritoneum or liver or lung
Complex liver-perenchymal sparing surgery or hemihepatectomy procedures are to be excluded.
Previous CRS or HIPEC
Pregnant or lactating (nursing) women
Active infections requiring antibiotics
Active liver disease with positive serology for active hepatitis B, C, or known HIV
Concurrent administration of any cancer therapy other than planned study treatment within 4 weeks prior to and up to 4 weeks after study treatment
Incomplete cytoreduction defined as completeness of cytoreduction score 2-3
Histopathology of other origin than colorectal cancer

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

Здоровые добровольцы: Нет