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

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.

Study Overview

• Status: Recruiting
• Conditions: Locally Advanced Salivary Gland Carcinoma
• Intervention / Treatment: Procedure: simultaneous postoperative radiochemotherapy

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Marlen Haderlein, PD Dr.; Phone Number: 33968 0913185; Email: marlen.haderlein@uk-erlangen.de
• Study Contact Backup: Name: Studiensekretariat; Phone Number: 33968 0913185; Email: studiensekretariat.ST@uk-erlangen.de

Study Locations

• Germany
  • Erlangen, Germany, 91054
    • Recruiting
    • Erlangen, Universitätsklinikum Strahlenklinik
    • Contact: Marlen Haderlein, PD Dr.; Phone Number: 33968 +499131-85-; Email: marlen.haderlein@uk-erlangen.de
    • Contact: Studiensekretariat; Phone Number: 33968 +49 9131 85-; Email: studiensekretariat.ST@uk-erlangen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient; Patients with locally advanced high-grade salivary gland carcinoma after oncological resection	Procedure: simultaneous postoperative radiochemotherapy; The efficacy and tolerability of simultaneous postoperative radiochemotherapy is being investigated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Creation of a database	Creation of a database of a representative homogeneously treated patient cohort with locally advanced salivary gland tumours receiving postoperative radiochemotherapy.	63 months (12 weeks therapy plus 5 years follow-up)

Secondary Outcome Measures

Outcome 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)

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School
• Investigators: Principal Investigator: Marlen Haderlein, PD Dr., Universitätsklinikum Erlangen, Strahlenklinik

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): June 1, 2036
• Study Completion (Estimated): June 1, 2037

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Salivary Gland Diseases; Mouth Neoplasms; Carcinoma; Salivary Gland Neoplasms
• Other Study ID Numbers: GlandulaSimultan

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No