Prospective Registry Study on the Implementation of Simultaneous Postoperative Radiochemotherapy for Salivary Gland Carcinomas of the Head and Neck Region
NCT ID: NCT06464198
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2024-06-01
2037-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patient
Patients with locally advanced high-grade salivary gland carcinoma after oncological resection
simultaneous postoperative radiochemotherapy
The efficacy and tolerability of simultaneous postoperative radiochemotherapy is being investigated.
Interventions
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simultaneous postoperative radiochemotherapy
The efficacy and tolerability of simultaneous postoperative radiochemotherapy is being investigated.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
99 Years
ALL
No
Sponsors
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University of Erlangen-Nürnberg Medical School
OTHER
Responsible Party
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Principal Investigators
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Marlen Haderlein, PD Dr.
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Erlangen, Strahlenklinik
Locations
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Erlangen, Universitätsklinikum Strahlenklinik
Erlangen, , Germany
Countries
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Central Contacts
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Facility Contacts
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Marlen Haderlein, PD Dr.
Role: primary
Studiensekretariat
Role: backup
Other Identifiers
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GlandulaSimultan
Identifier Type: -
Identifier Source: org_study_id