Actively Recruiting

Age: 18Years - 99Years
All Genders
NCT06464198

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

Led by University of Erlangen-Nürnberg Medical School · Updated on 2026-03-13

100

Participants Needed

1

Research Sites

678 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 (no distant metastases)
  • Indication for postoperative combined radiochemotherapy following guidelines
  • Percutaneous radiotherapy up to 64-72 Gy depending on resection status
  • Chemotherapy regimens including paclitaxel with cisplatin or carboplatin in specified dosing schedules
  • Patient age 18 years or older
  • WHO performance score of 0 or 1
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Presence of distant metastases
  • Other cancer diagnosed within the last 5 years, except adequately treated skin cancer (non-melanoma), lentigo maligno, or carcinoma in situ without active disease
  • Previous chemotherapy or radiotherapy for salivary gland carcinoma
  • Previous radiotherapy in the head and neck region
  • Uncontrolled medical conditions contraindicating combined chemotherapy (e.g., recent heart attack, heart failure, severe heart disease, resistant infection, immunodeficiency)
  • Pregnancy or breastfeeding
  • Fertile patients unable to ensure effective contraception during and for six months after therapy

AI-Screening

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Trial Site Locations

Total: 1 location

1

Erlangen, Universitätsklinikum Strahlenklinik

Erlangen, Germany, 91054

Actively Recruiting

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Research Team

M

Marlen Haderlein, PD Dr.

CONTACT

S

Studiensekretariat

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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