Registry for postoperative radiochemotherapy in salivary gland cancer
Prospective Registry Study on the Implementation of Simultaneous Postoperative Radiochemotherapy for Salivary Gland Carcinomas of the Head and Neck Region
This study is testing a new combined treatment of radiation and chemotherapy after surgery for people with advanced salivary gland cancer to see how well it works and how patients tolerate it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of Erlangen-Nürnberg Medical School Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Erlangen) |
| Trial ID | NCT06464198 on ClinicalTrials.gov |
What this trial studies
This prospective registry focuses on the implementation of simultaneous postoperative radiochemotherapy for patients with locally advanced high-grade salivary gland carcinoma following oncological resection. The study aims to evaluate the efficacy and tolerability of this treatment approach, which has been established in Erlangen and other locations. Eligible patients will receive guideline-compliant radiotherapy and chemotherapy regimens tailored to their specific conditions. The study will collect data on patient outcomes to better understand the impact of this combined treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with high-grade salivary gland carcinomas who have undergone successful oncological resection.
Not a fit: Patients with distant metastases or other cancers within the last five years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes for patients with advanced salivary gland carcinoma.
How similar studies have performed: Similar approaches in other studies have shown promise, but this specific registry is novel in its focus on salivary gland carcinoma.
Eligibility criteria
Show full 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
Where this trial is running
Erlangen
- Erlangen, Universitätsklinikum Strahlenklinik — Erlangen, Germany (Recruiting)
Study contacts
- Principal investigator: Marlen Haderlein, PD Dr. — Universitätsklinikum Erlangen, Strahlenklinik
- Study coordinator: Marlen Haderlein, PD Dr.
- Email: marlen.haderlein@uk-erlangen.de
- Phone: 0913185
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.