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NCT Number: NCT06464198

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

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.

Recruiting

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

simultaneous postoperative radiochemotherapy

Procedure

The efficacy and tolerability of simultaneous postoperative radiochemotherapy is being investigated.

Primary outcomes

  1. Creation of a database

    Time frame: 63 months (12 weeks therapy plus 5 years follow-up)

    Creation of a database of a representative homogeneously treated patient cohort with locally advanced salivary gland tumours receiving postoperative radiochemotherapy.

Secondary outcomes

  1. Observation of Overall survival

    Time frame: 63 months (12 weeks therapy plus 5 years follow-up)

  2. Observation of Disease-free survival

    Time frame: 63 months (12 weeks therapy plus 5 years follow-up)

  3. Observation of Disease-specific survival

    Time frame: 63 months (12 weeks therapy plus 5 years follow-up)

  4. Observation of Local recurrence-free survival

    Time frame: 63 months (12 weeks therapy plus 5 years follow-up)

  5. Observation of Survival free of distant metastases

    Time frame: 63 months (12 weeks therapy plus 5 years follow-up)

  6. Determination of toxicity

    Time frame: 63 months (12 weeks therapy plus 5 years follow-up)

Study contacts

Contact information is provided by the study sponsor or research team.

Marlen Haderlein, PD Dr.

CONTACT

[email protected]

0913185 ext. 33968

Studiensekretariat

CONTACT

[email protected]

0913185 ext. 33968

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Important dates

Study start
2024
Primary completion
2036
Study completion
2037
First posted
Jun 18, 2024
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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