Prospective Registry Study on the Implementation of Simultaneous Postoperative Radiochemotherapy for Salivary Gland Carcinomas of the Head and Neck Region

Обзор

This is a prospective registry study based on a standard therapy concept for postoperative simultaneous radiochemotherapy established in Erlangen and elsewhere. The efficacy and tolerability of simultaneous postoperative radiochemotherapy is being investigated. Patients with locally advanced high-grade salivary gland carcinoma after oncological resection are admitted.

Вмешательства

• Процедура simultaneous postoperative radiochemotherapy
  The efficacy and tolerability of simultaneous postoperative radiochemotherapy is being investigated.

Первичные конечные точки

• Creation of a database [Срок оценки: 63 months (12 weeks therapy plus 5 years follow-up)]

Вторичные конечные точки (6)

• Observation of Overall survival [Срок оценки: 63 months (12 weeks therapy plus 5 years follow-up)]
• Observation of Disease-free survival [Срок оценки: 63 months (12 weeks therapy plus 5 years follow-up)]
• Observation of Disease-specific survival [Срок оценки: 63 months (12 weeks therapy plus 5 years follow-up)]
• Observation of Local recurrence-free survival [Срок оценки: 63 months (12 weeks therapy plus 5 years follow-up)]
• Observation of Survival free of distant metastases [Срок оценки: 63 months (12 weeks therapy plus 5 years follow-up)]
• Determination of toxicity [Срок оценки: 63 months (12 weeks therapy plus 5 years follow-up)]

Критерии участия

Критерии включения

• Salivary gland carcinomas of the major and minor salivary glands of the head and neck region
• High-grade histology
• Successful oncological resection with curative intent
• pT3-4 or pN1-3 or Pn1(perineural sheath infiltration) or pT1-2 with scarce or positive resection margin
• cM0
• Indication for postoperative combined radiochemotherapy (guideline-compliant radiochemotherapy; percutaneous radiotherapy up to a total dose of 64-72 Gy (depending on resection status), common chemotherapy regimens: Paclitaxel 135mg/m² KOF d1 and cisplatin 33mg/m² KOF d1-3, q d22 or paclitaxel 135mg/m² KOF d1, carboplatin AUC 1.5 KOF d1-3 or paclitaxel 50mg/m² KOF, carboplatin AUC2 d1,8,15, q d22 or paclitaxel 50mg/m²KOF and cisplatin 30mg/m² KOF d1,8,15, q d22, 4 cycles each).
• Patient age ≥18 years
• WHO performance score ≤ 1
• Signed patient information/consent form

Критерии исключения

• Distant metastases
• Other cancer in the last 5 years prior to study inclusion (with the exception of: adequately treated skin cancer (except melanoma) or lentigo maligno or adequately treated carcinoma in situ, in each case without evidence of active disease).
• Previous chemotherapy or radiotherapy for salivary gland carcinoma
• Previous radiotherapy in the head and neck area
• Pre-existing uncontrolled disease that constitutes a contraindication to simultaneous combination chemotherapy (e.g. signs of acute heart failure, myocardial infarction within the last 6 months before the start of therapy, congestive heart failure, heart disease with New York Heart Association (NYHA) III or IV classification, active and therapy-resistant infection, pre-existing or concomitant immunodeficiency syndrome)
• Pregnancy and breastfeeding
• Fertile patients who cannot ensure effective contraception during and up to six months after combination therapy

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 1 центр

• Erlangen, Universitätsklinikum Strahlenklinik — Erlangen

Идентификаторы

NCT: NCT06464198 · GlandulaSimultan

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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