Prospective Registry Study on the Implementation of Simultaneous Postoperative Radiochemotherapy for Salivary Gland Carcinomas of the Head and Neck Region

Last updated: December 3, 2024
Sponsor: University of Erlangen-Nürnberg Medical School
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Treatment

simultaneous postoperative radiochemotherapy

Clinical Study ID

NCT06464198
GlandulaSimultan
  • Ages 18-99
  • All Genders

Study 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

Inclusion Criteria:

  • Salivary gland carcinomas of the major and minor salivary glands of the head andneck 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 orpositive resection margin

  • cM0

  • Indication for postoperative combined radiochemotherapy (guideline-compliantradiochemotherapy; percutaneous radiotherapy up to a total dose of 64-72 Gy (depending on resection status), common chemotherapy regimens: Paclitaxel 135mg/m²KOF 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, qd22 or paclitaxel 50mg/m²KOF and cisplatin 30mg/m² KOF d1,8,15, q d22, 4 cycleseach).

  • Patient age ≥18 years

  • WHO performance score ≤ 1

  • Signed patient information/consent form

Exclusion

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 adequatelytreated 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 tosimultaneous combination chemotherapy (e.g. signs of acute heart failure, myocardialinfarction within the last 6 months before the start of therapy, congestive heartfailure, heart disease with New York Heart Association (NYHA) III or IVclassification, active and therapy-resistant infection, pre-existing or concomitantimmunodeficiency syndrome)

  • Pregnancy and breastfeeding

  • Fertile patients who cannot ensure effective contraception during and up to sixmonths after combination therapy

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: simultaneous postoperative radiochemotherapy
Phase:
Study Start date:
June 01, 2024
Estimated Completion Date:
June 30, 2037

Connect with a study center

  • Erlangen, Universitätsklinikum Strahlenklinik

    Erlangen, 91054
    Germany

    Active - Recruiting

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