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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carbon Ion irradiation | Experimental | 22 x 3 Gy(RBE) Carbon Ions |
|
| Bimodal Arm | Active Comparator | 25 x 2 Gy photon IMRT and 8 x 3 Gy(RBE) Carbon ion boost |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbon ion irradiation | Radiation | 22 x 3 Gy(RBE) Carbon Ions |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from loco-regional progression | Freedom from loco-regional tumor progression according to MR imaging | at 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Progression-free survival | at 3 and 5 years |
| Overall survival | Overall survival | at 3 and 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Klaus Herfarth, Prof. Dr. | Contact | +49 6221 56 8201 | klaus.herfarth@med.uni-heidelberg.de |
| Name | Affiliation | Role |
|---|---|---|
| Klaus Herfarth, Prof. Dr. | University Hospital Heidelberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Heidelberg, Radiooncology, HIT | Recruiting | Heidelberg | 69120 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34266402 | Derived | Lang K, Adeberg S, Harrabi S, Held T, Kieser M, Debus J, Herfarth K. Adenoid cystic Carcinoma and Carbon ion Only irradiation (ACCO): Study protocol for a prospective, open, randomized, two-armed, phase II study. BMC Cancer. 2021 Jul 15;21(1):812. doi: 10.1186/s12885-021-08473-5. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2018 | Dec 27, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003528 | Carcinoma, Adenoid Cystic |
| D012468 | Salivary Gland Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Bimodal irradiation |
| Radiation |
25 x 2 Gy photon IMRT + 8 x 3 Gy(RBE) Carbon ion boost |
|
| Acute toxicities | Acute toxicities according to NCI CTC AE (Version 5.0) (rate of toxicity > 2 grade) | during and up to 6 weeks after radiotherapy |
| Late toxicities | Late toxicities according to NCI CTC AE (Version 5.0) (rate of toxicity > 2 grade) | up to 5 years |
| D009369 | Neoplasms |
| D009062 | Mouth Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D012466 | Salivary Gland Diseases |