Locally Advanced Salivary Gland Carcinoma
Conditions
Brief 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.
Interventions
PROCEDUREsimultaneous postoperative radiochemotherapy
The efficacy and tolerability of simultaneous postoperative radiochemotherapy is being investigated.
Sponsors
University of Erlangen-Nürnberg Medical School
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* 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 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Creation of a database | 63 months (12 weeks therapy plus 5 years follow-up) | Creation of a database of a representative homogeneously treated patient cohort with locally advanced salivary gland tumours receiving postoperative radiochemotherapy. |
Secondary
| Measure | Time frame |
|---|---|
| Observation of Overall survival | 63 months (12 weeks therapy plus 5 years follow-up) |
| Observation of Disease-free survival | 63 months (12 weeks therapy plus 5 years follow-up) |
| Observation of Disease-specific survival | 63 months (12 weeks therapy plus 5 years follow-up) |
| Observation of Local recurrence-free survival | 63 months (12 weeks therapy plus 5 years follow-up) |
| Observation of Survival free of distant metastases | 63 months (12 weeks therapy plus 5 years follow-up) |
| Determination of toxicity | 63 months (12 weeks therapy plus 5 years follow-up) |
Countries
Germany
Contacts
CONTACTMarlen Haderlein, PD Dr.
CONTACTStudiensekretariat
PRINCIPAL_INVESTIGATORMarlen Haderlein, PD Dr.
Universitätsklinikum Erlangen, Strahlenklinik
Outcome results
None listed