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Клинические исследования в Украине

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Исследования / № 00122460

Описание
Краткое названиеCetuximab (Erbitux) in Combination With Cisplatin or Carboplatin and 5-fluorouracil in the First Line Treatment of Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (EXTREME)
Полное названиеCetuximab in Combination With Cisplatin or Carboplatin and 5-fluorouracil in the First Line Treatment of Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
СпонсорMerck KGaA
Industry
ИсточникMerck KGaA
Под контролемBelgium: Directorate general for the protection of Public health: Medicines
Yes
Краткое описаниеThe purpose of this trial is to investigate the efficacy of cetuximab in combination with
chemotherapy in comparison to chemotherapy alone in patients with recurrent or metastatic
head and neck cancer who did not receive prior chemotherapy. Overall survival will be taken
as the primary measure of efficacy.
СостояниеАктивный, набор окончен
Дата началаDecember 2004
ФазаPhase 3
Вид исследованияAllocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Набор0
КритерииInclusion Criteria:

- Histologically and cytologically confirmed diagnosis of squamous cell carcinoma of
the head and neck (SCCHN)

- Recurrent and/or metastatic SCCHN, not suitable for local therapy

Exclusion Criteria:

- Prior systemic chemotherapy, except if given as part of a multimodal treatment for
locally advanced disease which was completed more than 6 months prior to study entry

- Surgery (excluding prior diagnostic biopsy), or irradiation within 4 weeks before
study entry

- Nasopharyngeal carcinoma
ПолBoth
Минимальный возраст18 Years
Максимальный возрастN/A
УсловиеHead and Neck Cancer
Применяемое лечение
DrugCetuximab+Platinum (Cis or Carboplatin)+5FU
DrugPlatinum (Cis or Carboplatin)+5FU
Контакты и расположение
Donetsk Research Site
Kharkiv Research Site
Kylv Research Site
Sumy Research Site
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