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

March 11, 2026 updated by: University of Erlangen-Nürnberg Medical School
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

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 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.
63 months (12 weeks therapy plus 5 years follow-up)

Secondary Outcome Measures

Outcome Measure
Time Frame
Observation of Overall survival
Time Frame: 63 months (12 weeks therapy plus 5 years follow-up)
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)
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)
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)
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)
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)
63 months (12 weeks therapy plus 5 years follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Investigators

  • Principal Investigator: Marlen Haderlein, PD Dr., Universitätsklinikum Erlangen, Strahlenklinik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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