Locally Advanced Salivary Gland CarcinomaNCT06464198
Prospective Registry Study on the Implementation of Simultaneous Postoperative Radiochemotherapy for Salivary Gland Carcinomas of the Head and Neck Region
An observational study of Locally Advanced Salivary Gland Carcinoma, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Locally Advanced Salivary Gland Carcinoma
- What is being tested?
- simultaneous postoperative radiochemotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2024to Jun 2037
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
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- Patient age ≥18 years
- WHO performance score ≤ 1
- Signed patient information/consent form
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Erlangen, Universitätsklinikum Strahlenklinik
Erlangen, 91054
Marlen Haderlein, PD Dr., +499131-85- ext. 33968, marlen.haderlein@uk-erlangen.de
Studiensekretariat, +49 9131 85- ext. 33968, studiensekretariat.ST@uk-erlangen.de
About this study
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.
- Being tested
- simultaneous postoperative radiochemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simultaneous postoperative radiochemotherapyProcedure or surgery
The efficacy and tolerability of simultaneous postoperative radiochemotherapy is being investigated.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Patients with locally advanced high-grade salivary gland carcinoma after oncological resection Receives: Procedure: simultaneous postoperative radiochemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creation of a database
Creation of a database of a representative homogeneously treated patient cohort with locally advanced salivary gland tumours receiving postoperative radiochemotherapy.
Measured: 63 months (12 weeks therapy plus 5 years follow-up)
Secondary outcomes (6)
Observation of Overall survival
Measured: 63 months (12 weeks therapy plus 5 years follow-up)
Observation of Disease-free survival
Measured: 63 months (12 weeks therapy plus 5 years follow-up)
Observation of Disease-specific survival
Measured: 63 months (12 weeks therapy plus 5 years follow-up)
Observation of Local recurrence-free survival
Measured: 63 months (12 weeks therapy plus 5 years follow-up)
Observation of Survival free of distant metastases
Measured: 63 months (12 weeks therapy plus 5 years follow-up)
Determination of toxicity
Measured: 63 months (12 weeks therapy plus 5 years follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start1 Jun 2024
- Primary completionJun 2036 (estimated)
- Study completionJun 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Salivary Gland CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marlen Haderlein, PD Dr., Principal investigator, Universitätsklinikum Erlangen, Strahlenklinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464198
- Sponsor's protocol ID
- GlandulaSimultan
- Status last verified
- Jan 2026
- First submitted
- 12 Jun 2024
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry Study on the Implementation of Simultaneous Postoperative Radiochemotherapy for Salivary Gland Carcinomas of the Head and Neck Region
- ClinicalTrials.gov ID
- NCT06464198
- Acronym / sponsor ID
- GlandulaSimultan
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Jun 2036 (estimated)
- Study completion
- Jun 2037 (estimated)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Procedure: simultaneous postoperative radiochemotherapyPatients with locally advanced high-grade salivary gland carcinoma after oncological resection |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| simultaneous postoperative radiochemotherapyThe efficacy and tolerability of simultaneous postoperative radiochemotherapy is being investigated. | Procedure or surgery | Patient |
Primary outcome
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.
6 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marlen Haderlein, PD Dr. principal investigator
Universitätsklinikum Erlangen, Strahlenklinik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced Salivary Gland Carcinoma, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marlen Haderlein, PD Dr. (0913185 ext. 33968, marlen.haderlein@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creation of a database (time frame: 63 months (12 weeks therapy plus 5 years follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026; AzTrials last refreshed its copy on 4 Nov 2026.