About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients with locally advanced high-grade salivary gland carcinoma after oncological resection who fulfil the inclusion and exclusion criteria are included. Patients must be adequately informed about their diagnosis and about the nature, significance and scope of the study.
Trial design
Cohort
Prospective
Treatments tested in this trial
simultaneous postoperative radiochemotherapy
Procedure/SurgeryThe efficacy and tolerability of simultaneous postoperative radiochemotherapy is being investigated.
Treatment groups
Trial outcomes
Primary outcomes
Creation of a database
Creation of a database of a representative homogeneously treated patient cohort with locally advanced salivary gland tumours receiving postoperative radiochemotherapy.
Secondary outcomes
Observation of Overall survival
Observation of Disease-free survival
Observation of Disease-specific survival
Observation of Local recurrence-free survival
Sponsors and contacts
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