Набор скоро начнётся NCT07361133

Cyclophosphamide and Etoposide as a Metronomic Therapy in Advanced Head and Neck Squamous Cell Cancer

Фаза II С лечением Squamous Cell Carcinoma Advanced Head and Neck 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: В протоколе указаны: Cyclophosphamide and Etoposide in combination, Methotrexate.
Кому может быть актуально: Состояния в реестре: Squamous Cell Carcinoma, Advanced Head and Neck Cancer. Базовые параметры: от 18 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: Египет
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

Cyclophosphamide and Etoposide as a Promising Metronomic Therapy in Advanced Head and Neck Squamous Cell Carcinoma

Обзор

The goal of this clinical trial is to learn if drugs as cyclophosphamide (C) and etoposide (E) work to treat advanced head and neck cancer in adults. It will also learn about the safety of both drugs. The main questions it aims to answer are: Do drugs C and E work to treat advanced head and neck cancer, after failure on first line chemotherapy? What medical problems do participants have when taking drugs C and E? Researchers will compare drugs C and E in combination to a placebo (a look-alike substance that contains no drug) to see if these 2 drugs works to treat advanced head and neck cancer. Participants will: Take drug C every 3 weeks and drug E every 4 weeks or a placebo every week for 6 months. Visit the clinic once every 3 weeks for checkups and tests. Keep a diary of their symptoms.

Подробное описание

This clinical trial aims to evaluate the potential efficacy of cyclophosphamide and etoposide as metronomic therapy in recurrent/resistant and/or metastatic head and neck squamous cell carcinoma adults after failure on first line chemotherapy, or intolerant to further aggressive chemotherapy.

Вмешательства

Препарат Cyclophosphamide and Etoposide in combination
Cyclophosphamide IV 400 mg/m2 every 3 weeks and etoposide 100 mg/m2 daily for 3 days every 4 weeks for 6 months.
Препарат Methotrexate
50 mg weekly for 6 months

Первичные конечные точки

The efficacy of Cyclophosphamide and Etoposide as metronomic therapy [Срок оценки: From first day of the study to the end of treatment at 6 months.]

Вторичные конечные точки (3)

Assessment of clinical symptoms [Срок оценки: From the first day of the study till the end of treatment at 6 months]
Progression free survival [Срок оценки: From first day of the study till the end of study at 6 months]
Overall survival [Срок оценки: From the first day of study till the end of study at 8 months]

Критерии участия

Критерии включения

Adult participants, age = or > 18 years
Participants with recurrent head and neck squamous cell carcinoma after failure on first line chemotherapy.
Participants with advanced progressed, resistant, metastatic head and neck squamous cell carcinoma.