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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorUniversity of Erlangen-Nürnberg Medical School

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • simultaneous postoperative radiochemotherapy

    Procedure/Surgery

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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Patient1 intervention

Trial outcomes

Primary outcomes

1

Creation of a database

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

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

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)

Other outcomes

Sponsors and contacts

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