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

Status

Enrolling

Conditions

Locally Advanced Salivary Gland Carcinoma

Treatments

Procedure: simultaneous postoperative radiochemotherapy

Study type

Observational

Funder types

Other

Identifiers

NCT06464198

GlandulaSimultan

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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