Personalized neck irradiation guided by sentinel lymph node biopsy in patients with squamous cell carcinoma of the oropharynx, larynx or hypopharynx with a clinically negative neck: (Chemo)radiotherapy to the PRIMary tumor only. Protocol of the PRIMO study
Background: Elective neck irradiation (ENI) is performed in head and neck cancer patients treated with definitive (chemo)radiotherapy. The aim is to eradicate nodal metastases that are not detectable by pretreatment imaging techniques. It is conceivable that personalized neck irradiation can be perf...
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| Format: | Article |
| Language: | English |
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Elsevier
2024-01-01
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| Series: | Clinical and Translational Radiation Oncology |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2405630823001210 |
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| author | S. van den Bosch R.P. Takes M. de Ridder R. de Bree A. Al-Mamgani W.H. Schreuder F.J.P. Hoebers S. van Weert J.B.W. Elbers J.A. Hardillo T.W.H. Meijer B.E.C. Plaat M.A. de Jong J.C. Jansen D.J. Wellenstein G.B. van den Broek W.V. Vogel A.I.J. Arens J.H.A.M. Kaanders |
| author_facet | S. van den Bosch R.P. Takes M. de Ridder R. de Bree A. Al-Mamgani W.H. Schreuder F.J.P. Hoebers S. van Weert J.B.W. Elbers J.A. Hardillo T.W.H. Meijer B.E.C. Plaat M.A. de Jong J.C. Jansen D.J. Wellenstein G.B. van den Broek W.V. Vogel A.I.J. Arens J.H.A.M. Kaanders |
| author_sort | S. van den Bosch |
| collection | DOAJ |
| description | Background: Elective neck irradiation (ENI) is performed in head and neck cancer patients treated with definitive (chemo)radiotherapy. The aim is to eradicate nodal metastases that are not detectable by pretreatment imaging techniques. It is conceivable that personalized neck irradiation can be performed guided by the results of sentinel lymph node biopsy (SLNB). It is expected that ENI can be omitted to one or both sides of the neck in 9 out of 10 patients, resulting in less radiation side effects with better quality of life. Methods/design: This is a multicenter randomized controlled trial aiming to compare safety and efficacy of treatment with SLNB guided neck irradiation versus standard bilateral ENI in 242 patients with cN0 squamous cell carcinoma of the oropharynx, larynx or hypopharynx for whom bilateral ENI is indicated. Patients randomized to the experimental-arm will undergo SLNB. Based on the histopathologic status of the SLNs, patients will receive no ENI (if all SLNs are negative), unilateral neck irradiation only (if a SLN is positive at one side of the neck) or bilateral neck irradiation (if SLNs are positive at both sides of the neck). Patients randomized to the control arm will not undergo SLNB but will receive standard bilateral ENI. The primary safety endpoint is the number of patients with recurrence in regional lymph nodes within 2 years after treatment. The primary efficacy endpoint is patient reported xerostomia-related quality of life at 6 months after treatment. Discussion: If this trial demonstrates that the experimental treatment is non-inferior to the standard treatment in terms of regional recurrence and is superior in terms of xerostomia-related quality of life, this will become the new standard of care. |
| first_indexed | 2024-03-09T01:27:03Z |
| format | Article |
| id | doaj.art-1720da018ca243339b02a1dc80908b2a |
| institution | Directory Open Access Journal |
| issn | 2405-6308 |
| language | English |
| last_indexed | 2024-03-09T01:27:03Z |
| publishDate | 2024-01-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Clinical and Translational Radiation Oncology |
| spelling | doaj.art-1720da018ca243339b02a1dc80908b2a2023-12-10T06:16:36ZengElsevierClinical and Translational Radiation Oncology2405-63082024-01-0144100696Personalized neck irradiation guided by sentinel lymph node biopsy in patients with squamous cell carcinoma of the oropharynx, larynx or hypopharynx with a clinically negative neck: (Chemo)radiotherapy to the PRIMary tumor only. Protocol of the PRIMO studyS. van den Bosch0R.P. Takes1M. de Ridder2R. de Bree3A. Al-Mamgani4W.H. Schreuder5F.J.P. Hoebers6S. van Weert7J.B.W. Elbers8J.A. Hardillo9T.W.H. Meijer10B.E.C. Plaat11M.A. de Jong12J.C. Jansen13D.J. Wellenstein14G.B. van den Broek15W.V. Vogel16A.I.J. Arens17J.H.A.M. Kaanders18Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, The Netherlands; Corresponding author at: Radboud University Medical Center, Department of Radiation Oncology, huispost 874, P.O. Box 9101, Nijmegen 6500 HB, The Netherlands.Department of Otorhinolaryngology and Head and Neck Surgery, Radboud University Medical Center, Nijmegen, The NetherlandsDepartment of Radiation Oncology, University Medical Center Utrecht, Utrecht, The NetherlandsDepartment of Head and Neck Surgical Oncology, University Medical Center Utrecht, Utrecht, The NetherlandsDepartment of Radiation Oncology, Netherlands Cancer Institute/Antoni van Leeuwenhoek, Amsterdam, The NetherlandsDepartment of Head and Neck Surgical Oncology, Netherlands Cancer Institute/Antoni van Leeuwenhoek, Amsterdam, The NetherlandsDepartment of Radiation Oncology (Maastro), Maastricht University Medical Center+, GROW-School for Oncology and Reproduction, Maastricht, The NetherlandsDepartment of Otorhinolaryngology and Head and Neck Surgery, Maastricht University Medical Center+, Maastricht, The NetherlandsDepartment of Radiation Oncology, Erasmus MC Cancer Centre, Rotterdam, The NetherlandsDepartment of Otorhinolaryngology and Head and Neck Surgery, Erasmus MC Cancer Centre, Rotterdam, The NetherlandsDepartment of Radiation Oncology, University Medical Center Groningen, Groningen, The NetherlandsDepartment of Otorhinolaryngology and Head and Neck Surgery, University Medical Center Groningen, Groningen, The NetherlandsDepartment of Radiation Oncology, Leiden University Medical Center, Leiden, The NetherlandsDepartment of Otorhinolaryngology and Head and Neck Surgery, Leiden University Medical Center, Leiden, The NetherlandsDepartment of Otorhinolaryngology and Head and Neck Surgery, Radboud University Medical Center, Nijmegen, The NetherlandsDepartment of Otorhinolaryngology and Head and Neck Surgery, Radboud University Medical Center, Nijmegen, The NetherlandsDepartment of Medical Imaging/Department of Nuclear Medicine, Netherlands Cancer Institute/Antoni van Leeuwenhoek, Amsterdam, The NetherlandsDepartment of Medical Imaging/Department of Nuclear Medicine, Radboud University Medical Center, Nijmegen, The NetherlandsDepartment of Radiation Oncology, Radboud University Medical Center, Nijmegen, The NetherlandsBackground: Elective neck irradiation (ENI) is performed in head and neck cancer patients treated with definitive (chemo)radiotherapy. The aim is to eradicate nodal metastases that are not detectable by pretreatment imaging techniques. It is conceivable that personalized neck irradiation can be performed guided by the results of sentinel lymph node biopsy (SLNB). It is expected that ENI can be omitted to one or both sides of the neck in 9 out of 10 patients, resulting in less radiation side effects with better quality of life. Methods/design: This is a multicenter randomized controlled trial aiming to compare safety and efficacy of treatment with SLNB guided neck irradiation versus standard bilateral ENI in 242 patients with cN0 squamous cell carcinoma of the oropharynx, larynx or hypopharynx for whom bilateral ENI is indicated. Patients randomized to the experimental-arm will undergo SLNB. Based on the histopathologic status of the SLNs, patients will receive no ENI (if all SLNs are negative), unilateral neck irradiation only (if a SLN is positive at one side of the neck) or bilateral neck irradiation (if SLNs are positive at both sides of the neck). Patients randomized to the control arm will not undergo SLNB but will receive standard bilateral ENI. The primary safety endpoint is the number of patients with recurrence in regional lymph nodes within 2 years after treatment. The primary efficacy endpoint is patient reported xerostomia-related quality of life at 6 months after treatment. Discussion: If this trial demonstrates that the experimental treatment is non-inferior to the standard treatment in terms of regional recurrence and is superior in terms of xerostomia-related quality of life, this will become the new standard of care.http://www.sciencedirect.com/science/article/pii/S2405630823001210Head and neck cancerSentinel lymph node biopsyElective neck irradiationRadiotherapy |
| spellingShingle | S. van den Bosch R.P. Takes M. de Ridder R. de Bree A. Al-Mamgani W.H. Schreuder F.J.P. Hoebers S. van Weert J.B.W. Elbers J.A. Hardillo T.W.H. Meijer B.E.C. Plaat M.A. de Jong J.C. Jansen D.J. Wellenstein G.B. van den Broek W.V. Vogel A.I.J. Arens J.H.A.M. Kaanders Personalized neck irradiation guided by sentinel lymph node biopsy in patients with squamous cell carcinoma of the oropharynx, larynx or hypopharynx with a clinically negative neck: (Chemo)radiotherapy to the PRIMary tumor only. Protocol of the PRIMO study Clinical and Translational Radiation Oncology Head and neck cancer Sentinel lymph node biopsy Elective neck irradiation Radiotherapy |
| title | Personalized neck irradiation guided by sentinel lymph node biopsy in patients with squamous cell carcinoma of the oropharynx, larynx or hypopharynx with a clinically negative neck: (Chemo)radiotherapy to the PRIMary tumor only. Protocol of the PRIMO study |
| title_full | Personalized neck irradiation guided by sentinel lymph node biopsy in patients with squamous cell carcinoma of the oropharynx, larynx or hypopharynx with a clinically negative neck: (Chemo)radiotherapy to the PRIMary tumor only. Protocol of the PRIMO study |
| title_fullStr | Personalized neck irradiation guided by sentinel lymph node biopsy in patients with squamous cell carcinoma of the oropharynx, larynx or hypopharynx with a clinically negative neck: (Chemo)radiotherapy to the PRIMary tumor only. Protocol of the PRIMO study |
| title_full_unstemmed | Personalized neck irradiation guided by sentinel lymph node biopsy in patients with squamous cell carcinoma of the oropharynx, larynx or hypopharynx with a clinically negative neck: (Chemo)radiotherapy to the PRIMary tumor only. Protocol of the PRIMO study |
| title_short | Personalized neck irradiation guided by sentinel lymph node biopsy in patients with squamous cell carcinoma of the oropharynx, larynx or hypopharynx with a clinically negative neck: (Chemo)radiotherapy to the PRIMary tumor only. Protocol of the PRIMO study |
| title_sort | personalized neck irradiation guided by sentinel lymph node biopsy in patients with squamous cell carcinoma of the oropharynx larynx or hypopharynx with a clinically negative neck chemo radiotherapy to the primary tumor only protocol of the primo study |
| topic | Head and neck cancer Sentinel lymph node biopsy Elective neck irradiation Radiotherapy |
| url | http://www.sciencedirect.com/science/article/pii/S2405630823001210 |
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