JOURNAL ONKOLOGIE – STUDIE

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

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

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NCT-Nummer:
NCT06464198

Studienbeginn:
Juli 2024

Letztes Update:
21.06.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Carcinoma, Salivary Gland Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University of Erlangen-Nürnberg Medical School

Collaborator:
-

Studienleiter

Marlen Haderlein, PD Dr.
Principal Investigator
Universitätsklinikum Erlangen, Strahlenklinik

Kontakt

Marlen Haderlein, PD Dr.
Kontakt:
Phone: 0913185
Phone (ext.): 33968
E-Mail: marlen.haderlein@uk-erlangen.de» Kontaktdaten anzeigen

Studiensekretariat
Kontakt:
Phone: 0913185
Phone (ext.): 33968
E-Mail: studiensekretariat.ST@uk-erlangen.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Erlangen, Universitätsklinikum Strahlenklinik
91054 Erlangen
(Bayern)
Germany» Google-Maps
Ansprechpartner:
Marlen Haderlein, PD Dr.
Phone: +499131-85-
Phone (ext.): 33968
E-Mail: marlen.haderlein@uk-erlangen.de

Studiensekretariat
Phone: +49 9131 85-
Phone (ext.): 33968
E-Mail: studiensekretariat.ST@uk-erlangen.de» Ansprechpartner anzeigen

Studien-Informationen

Brief 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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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 outcome:

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))

Geprüfte Regime

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

Quelle: ClinicalTrials.gov

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