Prospective Registry Study on the Implementation of Simultaneous Postoperative Radiochemotherapy for Salivary Gland Carcinomas of the Head and Neck Region

Overview

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

• Procedure simultaneous postoperative radiochemotherapy
  The efficacy and tolerability of simultaneous postoperative radiochemotherapy is being investigated.

Primary outcome measures

• Creation of a database [Time frame: 63 months (12 weeks therapy plus 5 years follow-up)]

Secondary outcome measures (6)

• Observation of Overall survival [Time frame: 63 months (12 weeks therapy plus 5 years follow-up)]
• Observation of Disease-free survival [Time frame: 63 months (12 weeks therapy plus 5 years follow-up)]
• Observation of Disease-specific survival [Time frame: 63 months (12 weeks therapy plus 5 years follow-up)]
• Observation of Local recurrence-free survival [Time frame: 63 months (12 weeks therapy plus 5 years follow-up)]
• Observation of Survival free of distant metastases [Time frame: 63 months (12 weeks therapy plus 5 years follow-up)]
• Determination of toxicity [Time frame: 63 months (12 weeks therapy plus 5 years follow-up)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Germany · 1 center

• Erlangen, Universitätsklinikum Strahlenklinik — Erlangen

Identifiers

NCT: NCT06464198 · GlandulaSimultan

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗