Prospective Registry Study on the Implementation of Simultaneous Postoperative Radiochemotherapy for Salivary Gland Carcinomas of the Head and Neck Region
University of Erlangen-Nürnberg Medical School
100 participants
Jun 1, 2024
OBSERVATIONAL
Conditions
Summary
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
Inclusion Criteria9
- 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
Exclusion Criteria7
- 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
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Interventions
The efficacy and tolerability of simultaneous postoperative radiochemotherapy is being investigated.
Locations(1)
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NCT06464198