Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT04214366

Studienbeginn:
Dezember 2019

Letztes Update:
30.11.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Carcinoma, Carcinoma, Adenoid Cystic

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Heidelberg University

Collaborator:
-

Studienleiter

Klaus Herfarth, Prof. Dr.
Principal Investigator
University Hospital Heidelberg

Kontakt

Klaus Herfarth, Prof. Dr.
Kontakt:
Phone: +49 6221 56 8201
E-Mail: klaus.herfarth@med.uni-heidelberg.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University of Heidelberg, Radiooncology, HIT
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Klaus Herfarth, Prof. Dr.
Phone: +49 6221 568201
E-Mail: klausherfarth@med.uni-heidelberg.de» Ansprechpartner anzeigen

Studien-Informationen

Brief Summary:

Adenoid cystic tumors are rare tumors of the head and neck region. Despite their slow growth,

re-irradiation is often necessary due to the high metastatic risk. Patients are usually

irradiated with photons or, as here at the Heidelberg University Hospital, with a combination

of carbon ions and photons. So far, there is no data from Europe available for the sole

irradiation with carbon ions. The present ACCO (Adenoid Cystic Carcinoma and Carbon ion Only

irradiation) study, a prospective, open-label, phase II, single-arm, investigator-initiated

study, will therefore investigate the sole radiotherapy of carbon ions in this tumor entity.

Irradiation is applied - significantly shorter than the combination therapy - in about 4

weeks (22 fractions); patients are followed up for further 5 years after the start of

therapy. Carbon ions alone are expected to increase local tumor control rates from 60% to 70%

after 5 years (primary objective criterion of this study). In order to reject the null

hypothesis with a power of 80% and a significance level of 5%, 175 patients are included

(including a drop-out rate of 15%). Secondary objective criteria are progression-free

survival, overall survival, acute and late toxicity, and quality of life.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Histologically confirmed adenoid cystic carcinoma in the head and neck area

- Indication for irradiation:

- non-operable or

- R1/R2 resected or

- perineural sheat invasion (Pn+) or

- pT3/pT4

- Informed consent

- KI > 60% or ECOG 0/1 (minimum: self-sufficiency, normal activity or work not possible)

- Age 18-80 years

Exclusion Criteria:

- rejection of the study by the patient

- Patient is not able to consent

- Stage IV (distant metastases), except lung metastases < 1cm

- lymph node involvement (clinical or pathological)

- Previous radiotherapy in the head and neck area

- Active medical implants for which there is no ion radiation authorization at the time

of treatment (e.g., cardiac pacemaker, defibrillator, ...)

- Contraindication to MR imaging

- Simultaneous participation in another clinical study that could influence the outcome

of this study or the other study

- Pregnancy

Studien-Rationale

Primary outcome:

1. Freedom from loco-regional progression (Time Frame - at 5 years):
Freedom from loco-regional tumor progression according to MR imaging

Secondary outcome:

1. Progression-free survival (Time Frame - at 3 and 5 years):
Progression-free survival

2. Overall survival (Time Frame - at 3 and 5 years):
Overall survival

3. Acute toxicities (Time Frame - during and up to 6 weeks after radiotherapy):
Acute toxicities according to NCI CTC AE (Version 5.0) (rate of toxicity > 2 grade)

4. Late toxicities (Time Frame - up to 5 years):
Late toxicities according to NCI CTC AE (Version 5.0) (rate of toxicity > 2 grade)

Studien-Arme

Experimental: Carbon Ion irradiation
22 x 3 Gy(RBE) Carbon Ions
Active Comparator: Bimodal Arm
25 x 2 Gy photon IMRT and 8 x 3 Gy(RBE) Carbon ion boost

Geprüfte Regime

Carbon ion irradiation:
22 x 3 Gy(RBE) Carbon Ions
Bimodal irradiation:
25 x 2 Gy photon IMRT + 8 x 3 Gy(RBE) Carbon ion boost

Quelle: ClinicalTrials.gov

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