Clinical trial · Observational
Prospective Registry Study on the Implementation of Simultaneous Postoperative Radiochemotherapy for Salivary Gland Carcinomas of the Head and Neck Region
NCT06464198CI-TRIAL-00105495recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Salivary Gland Carcinoma | Salivary Gland Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| simultaneous postoperative radiochemotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patient
- description
- Patients with locally advanced high-grade salivary gland carcinoma after oncological resection
- interventionNames
- Procedure: simultaneous postoperative radiochemotherapy
Primary outcomes (1)
- measure
- Creation of a database
- timeFrame
- 63 months (12 weeks therapy plus 5 years follow-up)
- description
- Creation of a database of a representative homogeneously treated patient cohort with locally advanced salivary gland tumours receiving postoperative radiochemotherapy.
Secondary outcomes (6)
- measure
- Observation of Overall survival
- timeFrame
- 63 months (12 weeks therapy plus 5 years follow-up)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.