Clinical trial NCT06464198: Prospective Registry Study on the Implementation of Simultaneous Postoperative Radiochemotherapy for Salivary Gland Carcinomas of the Head and Neck Region
Official title: Prospective Registry Study on the Implementation of Simultaneous Postoperative Radiochemotherapy for Salivary Gland Carcinomas of the Head and Neck Region
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Locally Advanced Salivary Gland Carcinoma
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2024-06-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Creation of a database
timeFrame: 63 months (12 weeks therapy plus 5 years follow-up)
Secondary outcomes:
measure: Observation of Overall survival
timeFrame: 63 months (12 weeks therapy plus 5 years follow-up)
measure: Observation of Disease-free survival
timeFrame: 63 months (12 weeks therapy plus 5 years follow-up)
measure: Observation of Disease-specific survival
timeFrame: 63 months (12 weeks therapy plus 5 years follow-up)
measure: Observation of Local recurrence-free survival
timeFrame: 63 months (12 weeks therapy plus 5 years follow-up)
measure: Observation of Survival free of distant metastases
timeFrame: 63 months (12 weeks therapy plus 5 years follow-up)
measure: Determination of toxicity
timeFrame: 63 months (12 weeks therapy plus 5 years follow-up)
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Erlangen, Universitätsklinikum Strahlenklinik
Study officials:
affiliation: Universitätsklinikum Erlangen, Strahlenklinik
name: Marlen Haderlein, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References: