Adenoid cystic Carcinoma and Carbon Ion Only irradiatio

Phase 2

Recruiting

Conditions: C07
C08
C14
Malignant neoplasm of parotid gland
Malignant neoplasm of other and unspecified major salivary glands
Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx

Registration Number: DRKS00016792

Lead Sponsor: niversitätsklinikum HeidelbergAbteilung RadioOnkologie und Strahlentherapie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 314

Inclusion Criteria

Histologically confirmed adenoid cystic carcinoma in the head and neck area
Indication for irradiation:
- non-operable and/or
- R1/R2 resected and/or
- perineural sheat invasion (Pn+) and/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)
lymph node involvement (clinical or pathological), with exception of pulmonary metastases of = 1 cm
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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ocoregional tumor control according to MRI imaging after 5 years

Secondary Outcome Measures

Name	Time	Method
• Progression-free survival after 3 and 5 years<br>• Overall survival after 3 and 5 years<br>• Acute toxicities according to NCI CTC AE (Version 4.0) during and up to 6 weeks after radiotherapy (rate of toxicity > 2 grade)<br>• Late toxicities according to NCI CTC AE (Version 4.0) from 6 weeks after radiotherapy (rate of toxicity > 2 grade)<br>• Quality of life assessment according to EORTC QLQ-C30 and QLC H&N35<br>