Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04214366
Study type Interventional
Source Heidelberg University
Contact Klaus Herfarth, Prof. Dr.
Phone +49 6221 56 8201
Email klaus.herfarth@med.uni-heidelberg.de
Status Recruiting
Phase Phase 2
Start date December 1, 2019
Completion date December 1, 2032

See also
  Status Clinical Trial Phase
Recruiting NCT04973683 - AL101 Before Surgery for the Treatment of Notch Activated Adenoid Cystic Cancer Phase 1
Completed NCT01417143 - Dovitinib in Adenoid Cystic Carcinoma Phase 2
Recruiting NCT04140526 - Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC Phase 1/Phase 2
Active, not recruiting NCT05010629 - 9-ING-41 Plus Carboplatin in Salivary Gland Carcinoma Phase 2
Recruiting NCT04801264 - Diagnosis of Adenoid Cystic Carcinoma on 68Ga-PSMA-617 PET-CT and Therapy With 177Lu-EB-PSMA-617 Early Phase 1
Completed NCT03319641 - PSMA-PET Imaging for Advanced ACC/SDC N/A
Recruiting NCT02942693 - Trail Evaluating Particle Therapy With or Without Apatinib for H&N Adenoid Cystic Carcinoma Phase 2
Completed NCT00581360 - Phase II Trial of Doxorubicin and Bortezomib in Patients With Incurable Adenoid Cystic Carcinoma of the Head and Neck Phase 2
Not yet recruiting NCT05553782 - Drug Screening Using Novel IMD in ACC and Salivary Cancers Early Phase 1
Completed NCT04291300 - Lutetium-177-PSMA Radioligand Therapy in Advanced Salivary Gland Cancer Patients Phase 2
Active, not recruiting NCT02775370 - A Study of Apatinib in Recurrent/Metastatic Adenoid Cystic Carcinoma of the Head and Neck Phase 2
Active, not recruiting NCT02780310 - Testing Lenvatinib in Patients With Adenoid Cystic Carcinoma Phase 2
Completed NCT04119453 - A Study to Evaluate the Efficacy and Safety of Rivoceranib in Participants With Recurrent or Metastatic Adenoid Cystic Carcinoma (ACC) Phase 2
Active, not recruiting NCT02098538 - Regorafenib in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma Phase 2
Completed NCT01524692 - Study of Dovitinib (TKI258) in Adenoid Cystic Carcinoma Phase 2
Completed NCT01558661 - Axitinib (AG-013736) in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma Phase 2
Recruiting NCT03556228 - Selective TrkA Inhibitor VMD-928 to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma Phase 1
Recruiting NCT01192087 - Adenoid Cystic Carcinoma, Erbitux, and Particle Therapy Phase 1/Phase 2
Recruiting NCT04209660 - Lenvatinib and Pembrolizumab in People With Advanced Adenoid Cystic Carcinoma and Other Salivary Gland Cancers Phase 2
Recruiting NCT05774899 - CB-103 With Either Lenvatinib or Abemaciclib in Patients With NOTCH ACC Phase 1/Phase 2