Adenoid cystic Carcinoma and Carbon ion Only irradiation (ACCO): Study protocol for a prospective, open, randomized, two-armed, phase II study

Kristin Lang, Sebastian Adeberg, Semi Harrabi, Thomas Held, Meinhard Kieser, Jürgen Debus, Klaus Herfarth, Kristin Lang, Sebastian Adeberg, Semi Harrabi, Thomas Held, Meinhard Kieser, Jürgen Debus, Klaus Herfarth

Abstract

Background: Adenoid cystic carcinoma is a rare form of head and neck cancer with a slow, but aggressive growth pattern which remains a challenge for local tumor control. Based on phase II data, radiation treatment using partially high LET radiation results in a prolonged PFS and OS. There is a paucity of randomized clinical data examining the role of the use of high LET radiation only. Therefore, the purpose of this prospective clinical trial is to analyze local control rates in patients with node negative ACC treated with carbon ion radiotherapy alone compared to a combined modality approach.

Methods: This trial is conducted as a prospective, open-label, phase II, two-armed, investigator-initiated study comparing the local control rates in node negative ACCs of the head and neck treated either with sole carbon ion radiotherapy or a combination of carbon ions and photons. Secondary outcomes investigated are progression-free survival, overall survival, acute and late toxicity, and quality of life. A total of 314 patients will be randomly assigned to C12 treatment alone or bimodal treatment: Patients in the experimental group will receive a dose of 51 Gy (RBE) in 17 fractions and a boost of 15 Gy (RBE) in 5 fractions. Patients in the control group will receive 25 fractions photon IMRT 50Gy and a boost using 8 × 3 Gy (RBE) carbon ions. Local control will be assessed in regular follow up examinations until 5 years after the completion of treatment.

Discussion: The present trial aims to evaluate local control rates to compare sole carbon ion radiotherapy to bimodal radiotherapy with carbon ions and photons in patients with node negative ACCs of the head and neck region. Local control is selected as the primary endpoint due to its major clinical relevance because of slow but aggressive growth patterns.

Trial registration: The study was prospectively registered on 2nd January 2020: ClinicalTrials.gov, NCT04214366 . "Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation (ACCO)".

Study status: Under recruitment, participant recruitment is not completed. Start of recruitment was January 2020. There are no results been published or submitted to any journal.

Keywords: Adenoid cystic carcinoma; Carbon ions; Local control; Recurrence.

Conflict of interest statement

The current study has received major extramural funding within a competitive and peer-reviewed research grant financed by German Cancer Aid, Buschstraße 32, 52113 Bonn. German Cancer Aid is not involved in the design of the study, nor the collection, storage or analysis of the data gathered in this study. All authors declare that there is no conflict of interest in connection with the implementation and evaluation of this study.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Study workflow and treatment arms

References

    1. INTERNATIONAL HEAD AND NECK SCIENTIFIC GROUP Cervical lymph node metastasis in adenoid cystic carcinoma of the major salivary glands. J Laryngol Otol. 2017;131(2):96–105. doi: 10.1017/S0022215116009749.
    1. International Head And Neck Scientific Group Cervical lymph node metastasis in adenoid cystic carcinoma of the sinonasal tract, nasopharynx, lacrimal glands and external auditory canal: a collective international review. J Laryngol Otol. 2016;130(12):1093–1097. doi: 10.1017/S0022215116009373.
    1. Bradley PJ. Adenoid cystic carcinoma of the head and neck: a review. Curr Opin Otolaryngol Head Neck Surg. 2004;12(2):127–132. doi: 10.1097/00020840-200404000-00013.
    1. Jensen AD, Nikoghosyan AV, Lossner K, Haberer T, Jakel O, Munter MW, Debus J. COSMIC: a regimen of intensity modulated radiation therapy plus dose-escalated, raster-scanned carbon ion boost for malignant salivary gland tumors: results of the prospective phase 2 trial. Int J Radiat Oncol Biol Phys. 2015;93(1):37–46. doi: 10.1016/j.ijrobp.2015.05.013.
    1. Stannard C, Vernimmen F, Carrara H, Jones D, Fredericks S, Hille J, de Kock E. Malignant salivary gland tumours: can fast neutron therapy results point the way to carbon ion therapy? Radiother Oncol. 2013;109(2):262–268. doi: 10.1016/j.radonc.2013.08.013.
    1. Schulz-Ertner D, Nikoghosyan A, Didinger B, Munter M, Jakel O, Karger CP, Debus J. Therapy strategies for locally advanced adenoid cystic carcinomas using modern radiation therapy techniques. Cancer. 2005;104(2):338–344. doi: 10.1002/cncr.21158.
    1. Jensen AD, Nikoghosyan AV, Poulakis M, Hoss A, Haberer T, Jakel O, Munter MW, Schulz-Ertner D, Huber PE, Debus J. Combined intensity-modulated radiotherapy plus raster-scanned carbon ion boost for advanced adenoid cystic carcinoma of the head and neck results in superior locoregional control and overall survival. Cancer. 2015;121(17):3001–3009. doi: 10.1002/cncr.29443.
    1. Jensen AD, Poulakis M, Nikoghosyan AV, Chaudhri N, Uhl M, Munter MW, Herfarth KK, Debus J. Re-irradiation of adenoid cystic carcinoma: analysis and evaluation of outcome in 52 consecutive patients treated with raster-scanned carbon ion therapy. Radiother Oncol. 2015;114(2):182–188. doi: 10.1016/j.radonc.2015.01.002.
    1. Steinstrater O, Grun R, Scholz U, Friedrich T, Durante M, Scholz M. Mapping of RBE-weighted doses between HIMAC- and LEM-based treatment planning systems for carbon ion therapy. Int J Radiat Oncol Biol Phys. 2012;84(3):854–860. doi: 10.1016/j.ijrobp.2012.01.038.
    1. Mizoe JE, Tsujii H, Kamada T, Matsuoka Y, Tsuji H, Osaka Y, Hasegawa A, Yamamoto N, Ebihara S, Konno A. Dose escalation study of carbon ion radiotherapy for locally advanced head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2004;60(2):358–364. doi: 10.1016/j.ijrobp.2004.02.067.
    1. Ikawa H, Koto M, Takagi R, Ebner DK, Hasegawa A, Naganawa K, Takenouchi T, Nagao T, Nomura T, Shibahara T, Tsuji H, Kamada T. Prognostic factors of adenoid cystic carcinoma of the head and neck in carbon-ion radiotherapy: The impact of histological subtypes. Radiotherapy Oncol. 123(3):387–93. 10.1016/j.radonc.2017.04.026.
    1. Bentzen SM, Constine LS, Deasy JO, Eisbruch A, Jackson A, Marks LB, ten Haken RK, Yorke ED Quantitative analyses of normal tissue effects in the clinic (QUANTEC): An introduction to the Scientific Issues. Int J Radiat Oncol 2010; 76:S3–S9. 10.1016/j.ijrobp.2009.09.040, 3.
    1. Marks LB, Yorke ED, Jackson A, Ten Haken RK, Constine LS, Eisbruch A, et al. Use of Normal tissue complication probability models in the clinic. Int J Radiat Oncol. 2010;76: S10–S19. 10.1016/j.ijrobp.2009.07.1754, 3.
    1. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. JASA. 1958;53(282):457–481. doi: 10.1080/01621459.1958.10501452.
    1. Abt K. Descriptive data analysis: a concept between confirmatory and exploratory data analysis. Methods Inf Med. 1987;26(2):77–88. doi: 10.1055/s-0038-1635488.
    1. Schulz-Ertner D, Nikoghosyan A, Jäkel O, Haberer T, Kraft G, Scholz M, Wannenmacher M, Debus J. Feasibility and toxicity of combined photon and carbon ion radiotherapy for locally advanced adenoid cystic carcinomas. Int J Radiat Oncol Biol Phys. 2003;56(2):391–398. doi: 10.1016/S0360-3016(02)04511-X.
    1. Chen AM, Bucci MK, Weinberg V, Garcia J, Quivey JM, Schechter NR, Phillips TL, Fu KK, Eisele DW. Adenoid cystic carcinoma of the head and neck treated by surgery with or without postoperative radiation therapy: prognostic features of recurrence. Int J Radiat Oncol Biol Phys. 2006;66(1):152–159. doi: 10.1016/j.ijrobp.2006.04.014.
    1. Münter MW, Schulz-Ertner D, Hof H, Nikoghosyan A, Jensen A, Nill S, Huber P, Debus J. Inverse planned stereotactic intensity modulated radiotherapy (IMRT) in the treatment of incompletely and completely resected adenoid cystic carcinomas of the head and neck: initial clinical results and toxicity of treatment [serial online] Radiat Oncol. 2006;1(1):17. doi: 10.1186/1748-717X-1-17.
    1. Schulz-Ertner D, Nikoghosyan A, Thilmann C, Haberer T, Jäkel O, Karger C, Kraft G, Wannenmacher M, Debus J. Results of carbon ion therapy in 152 patients. Int J Radiat Oncol Biol Phys. 2004;58(2):631–640. doi: 10.1016/j.ijrobp.2003.09.041.

Source: PubMed

스폰서 및 공동 작업자

건강 상태

약물 개입

3
구독하다