Phase
Condition
Carcinoma
Treatment
simultaneous postoperative radiochemotherapy
Clinical Study ID
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Salivary gland carcinomas of the major and minor salivary glands of the head andneck 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 orpositive resection margin
cM0
Indication for postoperative combined radiochemotherapy (guideline-compliantradiochemotherapy; percutaneous radiotherapy up to a total dose of 64-72 Gy (depending on resection status), common chemotherapy regimens: Paclitaxel 135mg/m²KOF 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, qd22 or paclitaxel 50mg/m²KOF and cisplatin 30mg/m² KOF d1,8,15, q d22, 4 cycleseach).
Patient age ≥18 years
WHO performance score ≤ 1
Signed patient information/consent form
Exclusion
Exclusion Criteria:
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 adequatelytreated 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 tosimultaneous combination chemotherapy (e.g. signs of acute heart failure, myocardialinfarction within the last 6 months before the start of therapy, congestive heartfailure, heart disease with New York Heart Association (NYHA) III or IVclassification, active and therapy-resistant infection, pre-existing or concomitantimmunodeficiency syndrome)
Pregnancy and breastfeeding
Fertile patients who cannot ensure effective contraception during and up to sixmonths after combination therapy
Study Design
Connect with a study center
Erlangen, Universitätsklinikum Strahlenklinik
Erlangen, 91054
GermanyActive - Recruiting

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