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Accepted for/Published in: JMIR Research Protocols

Date Submitted: May 9, 2018
Open Peer Review Period: May 12, 2018 - May 31, 2018
Date Accepted: Jun 19, 2018
(closed for review but you can still tweet)

The final, peer-reviewed published version of this preprint can be found here:

Postoperative Bio-Chemoradiotherapy Using Cetuximab and Docetaxel in Patients With Cis-Platinum–Intolerant Core High-Risk Head and Neck Cancer: Protocol of a Phase 2 Nonrandomized Clinical Trial

Nishimura G, Hatakeyama H, Shiono O, Taguri M, Komatsu M, Sano D, Sakuma N, Yabuki K, Arai Y, Shibata K, Chiba Y, Tanabe T, Oridate N

Postoperative Bio-Chemoradiotherapy Using Cetuximab and Docetaxel in Patients With Cis-Platinum–Intolerant Core High-Risk Head and Neck Cancer: Protocol of a Phase 2 Nonrandomized Clinical Trial

JMIR Res Protoc 2018;7(8):e11003

DOI: 10.2196/11003

PMID: 30139721

PMCID: 6127497

Postoperative Bio-Chemoradiotherapy Using Cetuximab and Docetaxel in Patients With Cis-Platinum–Intolerant Core High-Risk Head and Neck Cancer: Protocol of a Phase 2 Nonrandomized Clinical Trial

  • Goshi Nishimura; 
  • Hiromitsu Hatakeyama; 
  • Osamu Shiono; 
  • Masataka Taguri; 
  • Masanori Komatsu; 
  • Daisuke Sano; 
  • Naoko Sakuma; 
  • Kenichiro Yabuki; 
  • Yasuhiro Arai; 
  • Kunihiko Shibata; 
  • Yoshihiro Chiba; 
  • Teruhiko Tanabe; 
  • Nobuhiko Oridate

ABSTRACT

Background:

We confirmed the safety of postoperative bio-chemoradiotherapy using cetuximab and docetaxel in a small number of patients with cis-platinum–intolerant core high-risk head and neck cancer.

Objective:

To assess treatment efficacy, we planned a phase 2 study of postoperative bio-chemoradiotherapy for patients with cis-platinum–intolerant core high-risk head and neck cancer and will compare the results to those of previously collected radiotherapy data.

Methods:

Patients who underwent definitive surgery for oral cavity, laryngeal, oropharyngeal, or hypopharyngeal advanced cancer, whose postoperative pathological results indicated core high risk for recurrence (eg, positive margin in the primary site or extranodal extension) and who were cis-platinum–intolerant, will undergo postoperative bio-chemoradiotherapy. The primary end point is 2-year disease-free survival.

Results:

The expected 2-year disease-free survival is set at 55%, and the calculated sample size is 35 patients, according to a statistical analysis based on previous reports.

Conclusions:

This treatment method is expected to improve the survival rate of patients with severe head and neck cancer. Trial Registration: UMIN Clinical Trials Registry UMIN000031835; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ ctr_view.cgi?recptno=R000036355 (Archived by WebCite at http://www.webcitation.org/71fejVjMr)


 Citation

Please cite as:

Nishimura G, Hatakeyama H, Shiono O, Taguri M, Komatsu M, Sano D, Sakuma N, Yabuki K, Arai Y, Shibata K, Chiba Y, Tanabe T, Oridate N

Postoperative Bio-Chemoradiotherapy Using Cetuximab and Docetaxel in Patients With Cis-Platinum–Intolerant Core High-Risk Head and Neck Cancer: Protocol of a Phase 2 Nonrandomized Clinical Trial

JMIR Res Protoc 2018;7(8):e11003

DOI: 10.2196/11003

PMID: 30139721

PMCID: 6127497

Per the author's request the PDF is not available.

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