Discontinuation of the double-blind, placebo-controlled randomized, phase III GORTEC 2022–01 trial of radiotherapy-cetuximab and xevinapant in patients with locally advanced squamous cell carcinoma of the head and neck, unfit for cisplatin.

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Title: Discontinuation of the double-blind, placebo-controlled randomized, phase III GORTEC 2022–01 trial of radiotherapy-cetuximab and xevinapant in patients with locally advanced squamous cell carcinoma of the head and neck, unfit for cisplatin.
Authors: Pointreau, Y.1 (AUTHOR) y.pointreau@ilcgroupe.fr, Larnaudie, A.2 (AUTHOR), Sun, X.S.3 (AUTHOR), Rolland, F.4 (AUTHOR), Boisselier, P.5 (AUTHOR), Tao, Y.6 (AUTHOR), Hugo, C.7 (AUTHOR), Bourhis, J.8 (AUTHOR)
Source: Radiotherapy & Oncology. Jun2026, Vol. 219, pN.PAG-N.PAG. 1p.
Subjects: Cetuximab, Head & neck cancer, Squamous cell carcinoma, Radiotherapy, Cisplatin, Apoptosis inhibition, Clinical trials, Adverse health care events
Abstract: XXL was a placebo-controlled phase 3 evaluating cetuximab-radiotherapy and xevinapant (IAP inhibitor) in locally advanced squamous cell carcinoma of the head and neck, ineligible for cisplatin (Unfit). Following the unfavorable outcomes of Trilynx [1] , XXL the trial was prematurely discontinued after the enrollment of 19 patients and subsequently unblinded; the safety analysis then revealed an increase in treatment-related deaths with xevinapant. [ABSTRACT FROM AUTHOR]
Copyright of Radiotherapy & Oncology is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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DbLabel: Engineering Source
An: 194047314
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  Data: Discontinuation of the double-blind, placebo-controlled randomized, phase III GORTEC 2022–01 trial of radiotherapy-cetuximab and xevinapant in patients with locally advanced squamous cell carcinoma of the head and neck, unfit for cisplatin.
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  Data: <searchLink fieldCode="AR" term="%22Pointreau%2C+Y%2E%22">Pointreau, Y.</searchLink><relatesTo>1</relatesTo> (AUTHOR)<i> y.pointreau@ilcgroupe.fr</i><br /><searchLink fieldCode="AR" term="%22Larnaudie%2C+A%2E%22">Larnaudie, A.</searchLink><relatesTo>2</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Sun%2C+X%2ES%2E%22">Sun, X.S.</searchLink><relatesTo>3</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Rolland%2C+F%2E%22">Rolland, F.</searchLink><relatesTo>4</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Boisselier%2C+P%2E%22">Boisselier, P.</searchLink><relatesTo>5</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Tao%2C+Y%2E%22">Tao, Y.</searchLink><relatesTo>6</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Hugo%2C+C%2E%22">Hugo, C.</searchLink><relatesTo>7</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Bourhis%2C+J%2E%22">Bourhis, J.</searchLink><relatesTo>8</relatesTo> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22Radiotherapy+%26+Oncology%22">Radiotherapy & Oncology</searchLink>. Jun2026, Vol. 219, pN.PAG-N.PAG. 1p.
– Name: Subject
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  Data: <searchLink fieldCode="DE" term="%22Cetuximab%22">Cetuximab</searchLink><br /><searchLink fieldCode="DE" term="%22Head+%26+neck+cancer%22">Head & neck cancer</searchLink><br /><searchLink fieldCode="DE" term="%22Squamous+cell+carcinoma%22">Squamous cell carcinoma</searchLink><br /><searchLink fieldCode="DE" term="%22Radiotherapy%22">Radiotherapy</searchLink><br /><searchLink fieldCode="DE" term="%22Cisplatin%22">Cisplatin</searchLink><br /><searchLink fieldCode="DE" term="%22Apoptosis+inhibition%22">Apoptosis inhibition</searchLink><br /><searchLink fieldCode="DE" term="%22Clinical+trials%22">Clinical trials</searchLink><br /><searchLink fieldCode="DE" term="%22Adverse+health+care+events%22">Adverse health care events</searchLink>
– Name: Abstract
  Label: Abstract
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  Data: XXL was a placebo-controlled phase 3 evaluating cetuximab-radiotherapy and xevinapant (IAP inhibitor) in locally advanced squamous cell carcinoma of the head and neck, ineligible for cisplatin (Unfit). Following the unfavorable outcomes of Trilynx [1] , XXL the trial was prematurely discontinued after the enrollment of 19 patients and subsequently unblinded; the safety analysis then revealed an increase in treatment-related deaths with xevinapant. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
  Label:
  Group: Ab
  Data: <i>Copyright of Radiotherapy & Oncology is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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RecordInfo BibRecord:
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      – Type: doi
        Value: 10.1016/j.radonc.2026.111479
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      – Code: eng
        Text: English
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        StartPage: N.PAG
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      – SubjectFull: Cetuximab
        Type: general
      – SubjectFull: Head & neck cancer
        Type: general
      – SubjectFull: Squamous cell carcinoma
        Type: general
      – SubjectFull: Radiotherapy
        Type: general
      – SubjectFull: Cisplatin
        Type: general
      – SubjectFull: Apoptosis inhibition
        Type: general
      – SubjectFull: Clinical trials
        Type: general
      – SubjectFull: Adverse health care events
        Type: general
    Titles:
      – TitleFull: Discontinuation of the double-blind, placebo-controlled randomized, phase III GORTEC 2022–01 trial of radiotherapy-cetuximab and xevinapant in patients with locally advanced squamous cell carcinoma of the head and neck, unfit for cisplatin.
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            – D: 01
              M: 06
              Text: Jun2026
              Type: published
              Y: 2026
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