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

NCT06464198 | Recruiting

• 1 other identifier: GlandulaSimultan
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. Patients with locally advanced high-grade salivary gland carcinoma after oncological resection are admitted.

Conditions

Locally Advanced Salivary Gland Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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)

Study Arms (1)

Patient

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

Procedure: simultaneous postoperative radiochemotherapy

Interventions

simultaneous postoperative radiochemotherapy PROCEDURE

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

Patient

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Distant metastases
• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

Erlangen, Universitätsklinikum Strahlenklinik

Erlangen, 91054, Germany

RECRUITING

Study Officials

• Marlen Haderlein, PD Dr.

  Universitätsklinikum Erlangen, Strahlenklinik

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marlen Haderlein, PD Dr.

CONTACT

0913185; marlen.haderlein@uk-erlangen.de

Studiensekretariat

CONTACT

0913185; studiensekretariat.ST@uk-erlangen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 18, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 1, 2036
• Study Completion (Estimated): June 1, 2037
• Last Updated: March 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)