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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational [Patient Registry]
Eligible Ages 18 Years - 99 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06464198
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Erlangen-Nürnberg Medical School
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Marlen Haderlein, PD Dr.
Principal Investigator Affiliation Universitätsklinikum Erlangen, Strahlenklinik
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Locally Advanced Salivary Gland Carcinoma
Arms & Interventions

Arms

: Patient

Patients with locally advanced high-grade salivary gland carcinoma after oncological resection

Interventions

Procedure: - simultaneous postoperative radiochemotherapy

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

Contact a Trial Team

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International Sites

Erlangen, Germany

Status

Address

Erlangen, Universitätsklinikum Strahlenklinik

Erlangen, , 91054

Site Contact

Marlen Haderlein, PD Dr.

[email protected]

+499131-85- #33968

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