The COMPLETE trial: HolistiC early respOnse assessMent for oroPharyngeaL cancEr paTiEnts; Protocol for an observational study
Introduction The locoregional failure (LRF) rate in human papilloma virus (HPV)-negative oropharyngeal squamous cell carcinoma (OPSCC) remains disappointingly high and toxicity is substantial. Response prediction prior to or early during treatment would provide opportunities for personalised treatme...
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BMJ Publishing Group
2022-05-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/5/e059345.full |
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| author | Aad van der Lugt Dik C van Gent Gerda M Verduijn Marta E Capala Nienke D Sijtsema Iris Lauwers Juan A Hernandez Tamames Wilma D Heemsbergen Aniel Sewnaik Jose A Hardillo Hetty Mast Yvette van Norden Maurice P H M Jansen Mischa S Hoogeman Bianca Mostert Steven F Petit |
| author_facet | Aad van der Lugt Dik C van Gent Gerda M Verduijn Marta E Capala Nienke D Sijtsema Iris Lauwers Juan A Hernandez Tamames Wilma D Heemsbergen Aniel Sewnaik Jose A Hardillo Hetty Mast Yvette van Norden Maurice P H M Jansen Mischa S Hoogeman Bianca Mostert Steven F Petit |
| author_sort | Aad van der Lugt |
| collection | DOAJ |
| description | Introduction The locoregional failure (LRF) rate in human papilloma virus (HPV)-negative oropharyngeal squamous cell carcinoma (OPSCC) remains disappointingly high and toxicity is substantial. Response prediction prior to or early during treatment would provide opportunities for personalised treatment. Currently, there are no accurate predictive models available for correct OPSCC patient selection. Apparently, the pivotal driving forces that determine how a OPSCC responds to treatment, have yet to be elucidated. Therefore, the holistiC early respOnse assessMent for oroPharyngeaL cancer paTiEnts study focuses on a holistic approach to gain insight in novel potential prognostic biomarkers, acquired before and early during treatment, to predict response to treatment in HPV-negative patients with OPSCC.Methods and analysis This single-centre prospective observational study investigates 60 HPV-negative patients with OPSCC scheduled for primary radiotherapy (RT) with cisplatin or cetuximab, according to current clinical practice. A holistic approach will be used that aims to map the macroscopic (with Intra Voxel Incoherent Motion Diffusion Kurtosis Imaging (IVIM-DKI); before, during, and 3 months after RT), microscopic (with biopsies of the primary tumour acquired before treatment and irradiated ex vivo to assess radiosensitivity), and molecular landscape (with circulating tumour DNA (ctDNA) analysed before, during and 3 months after treatment). The main end point is locoregional control (LRC) 2 years after treatment. The primary objective is to determine whether a relative change in the mean of the diffusion coefficient D (an IVIM-DKI parameter) in the primary tumour early during treatment, improves the performance of a predictive model consisting of tumour volume only, for 2 years LRC after treatment. The secondary objectives investigate the potential of other IVIM-DKI parameters, ex vivo sensitivity characteristics, ctDNA, and combinations thereof as potential novel prognostic markers.Ethics and dissemination The study was approved by the Medical Ethical Committee of Erasmus Medical Center. The main results of the trial will be presented in international meetings and medical journals.Trial registration number NL8458. |
| format | Article |
| id | doaj-art-19f15ce4516e4b28ada070fa85e6367a |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-05-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-19f15ce4516e4b28ada070fa85e6367a2025-08-20T02:16:56ZengBMJ Publishing GroupBMJ Open2044-60552022-05-0112510.1136/bmjopen-2021-059345The COMPLETE trial: HolistiC early respOnse assessMent for oroPharyngeaL cancEr paTiEnts; Protocol for an observational studyAad van der Lugt0Dik C van Gent1Gerda M Verduijn2Marta E Capala3Nienke D Sijtsema4Iris Lauwers5Juan A Hernandez Tamames6Wilma D Heemsbergen7Aniel Sewnaik8Jose A Hardillo9Hetty Mast10Yvette van Norden11Maurice P H M Jansen12Mischa S Hoogeman13Bianca Mostert14Steven F Petit15Radiology, Erasmus MC University Medical Center, Rotterdam, The Netherlands6 Molecular Genetics, Erasmus Medical Center, Rotterdam, The Netherlands1 Radiotherapy, Erasmus Medical Center, Rotterdam, The Netherlands1 Radiotherapy, Erasmus Medical Center, Rotterdam, The Netherlands1 Radiotherapy, Erasmus Medical Center, Rotterdam, The Netherlands1 Radiotherapy, Erasmus Medical Center, Rotterdam, The Netherlands2 Radiology and Nuclear Medicine, Erasmus Medical Center, Rotterdam, The Netherlands1 Radiotherapy, Erasmus Medical Center, Rotterdam, The Netherlands3 Otorhinolaryngology and Head and Neck surgery, Erasmus Medical Center, Rotterdam, The Netherlands3 Otorhinolaryngology and Head and Neck surgery, Erasmus Medical Center, Rotterdam, The Netherlands4 Oral and Maxillofacial surgery, Erasmus Medical Center, Rotterdam, The Netherlands1 Radiotherapy, Erasmus Medical Center, Rotterdam, The Netherlands5 Medical Oncology, Erasmus Medical Center, Rotterdam, The Netherlands1 Radiotherapy, Erasmus Medical Center, Rotterdam, The Netherlands5 Medical Oncology, Erasmus Medical Center, Rotterdam, The Netherlands1 Radiotherapy, Erasmus Medical Center, Rotterdam, The NetherlandsIntroduction The locoregional failure (LRF) rate in human papilloma virus (HPV)-negative oropharyngeal squamous cell carcinoma (OPSCC) remains disappointingly high and toxicity is substantial. Response prediction prior to or early during treatment would provide opportunities for personalised treatment. Currently, there are no accurate predictive models available for correct OPSCC patient selection. Apparently, the pivotal driving forces that determine how a OPSCC responds to treatment, have yet to be elucidated. Therefore, the holistiC early respOnse assessMent for oroPharyngeaL cancer paTiEnts study focuses on a holistic approach to gain insight in novel potential prognostic biomarkers, acquired before and early during treatment, to predict response to treatment in HPV-negative patients with OPSCC.Methods and analysis This single-centre prospective observational study investigates 60 HPV-negative patients with OPSCC scheduled for primary radiotherapy (RT) with cisplatin or cetuximab, according to current clinical practice. A holistic approach will be used that aims to map the macroscopic (with Intra Voxel Incoherent Motion Diffusion Kurtosis Imaging (IVIM-DKI); before, during, and 3 months after RT), microscopic (with biopsies of the primary tumour acquired before treatment and irradiated ex vivo to assess radiosensitivity), and molecular landscape (with circulating tumour DNA (ctDNA) analysed before, during and 3 months after treatment). The main end point is locoregional control (LRC) 2 years after treatment. The primary objective is to determine whether a relative change in the mean of the diffusion coefficient D (an IVIM-DKI parameter) in the primary tumour early during treatment, improves the performance of a predictive model consisting of tumour volume only, for 2 years LRC after treatment. The secondary objectives investigate the potential of other IVIM-DKI parameters, ex vivo sensitivity characteristics, ctDNA, and combinations thereof as potential novel prognostic markers.Ethics and dissemination The study was approved by the Medical Ethical Committee of Erasmus Medical Center. The main results of the trial will be presented in international meetings and medical journals.Trial registration number NL8458.https://bmjopen.bmj.com/content/12/5/e059345.full |
| spellingShingle | Aad van der Lugt Dik C van Gent Gerda M Verduijn Marta E Capala Nienke D Sijtsema Iris Lauwers Juan A Hernandez Tamames Wilma D Heemsbergen Aniel Sewnaik Jose A Hardillo Hetty Mast Yvette van Norden Maurice P H M Jansen Mischa S Hoogeman Bianca Mostert Steven F Petit The COMPLETE trial: HolistiC early respOnse assessMent for oroPharyngeaL cancEr paTiEnts; Protocol for an observational study BMJ Open |
| title | The COMPLETE trial: HolistiC early respOnse assessMent for oroPharyngeaL cancEr paTiEnts; Protocol for an observational study |
| title_full | The COMPLETE trial: HolistiC early respOnse assessMent for oroPharyngeaL cancEr paTiEnts; Protocol for an observational study |
| title_fullStr | The COMPLETE trial: HolistiC early respOnse assessMent for oroPharyngeaL cancEr paTiEnts; Protocol for an observational study |
| title_full_unstemmed | The COMPLETE trial: HolistiC early respOnse assessMent for oroPharyngeaL cancEr paTiEnts; Protocol for an observational study |
| title_short | The COMPLETE trial: HolistiC early respOnse assessMent for oroPharyngeaL cancEr paTiEnts; Protocol for an observational study |
| title_sort | complete trial holistic early response assessment for oropharyngeal cancer patients protocol for an observational study |
| url | https://bmjopen.bmj.com/content/12/5/e059345.full |
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