Prospective Registry Study on the Implementation of Simultaneous Postoperative Radiochemotherapy … (NCT06464198) | Clinical Trial Compass
RecruitingNot Applicable
Prospective Registry Study on the Implementation of Simultaneous Postoperative Radiochemotherapy for Salivary Gland Carcinomas of the Head and Neck Region
Germany100 participantsStarted 2024-06-01
Plain-language 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.
Who can participate
Age range18 Years – 99 Years
SexALL
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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 st…
What they're measuring
1
Creation of a database
Timeframe: 63 months (12 weeks therapy plus 5 years follow-up)
Trial details
NCT IDNCT06464198
SponsorUniversity of Erlangen-Nürnberg Medical School