New oral drug takes on standard chemo for head and neck cancer

NCT ID NCT01856478

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tested whether the oral drug afatinib works better than the standard injected drug methotrexate for people with advanced head and neck cancer that has worsened after platinum chemotherapy. The study enrolled 340 patients and measured how long they lived without the cancer growing (progression-free survival) and whether tumors shrank. The goal was to see if afatinib could offer a more convenient and effective treatment option.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

Afatinib (oral drug) and methotrexate (injected drug)

What this could lead to

If afatinib works better than methotrexate, it could offer a new, more convenient oral treatment option for advanced head and neck cancer that has stopped responding to platinum chemotherapy.

What could go wrong

This is a completed Phase 3 trial, so results are known. Afatinib may not be significantly better than methotrexate, and both drugs have side effects. The study only included certain types of head and neck cancer, so findings may not apply to all patients.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for HEAD AND NECK NEOPLASMS are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

head and neck neoplasm Head and Neck Neoplasms head and neck squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Acharya Tulsi Regional Cancer Treatment & Research Institute

    Bikaner, 334001, India

  • Alexandria Clinical Research Center

    Alexandria, 21131, Egypt

  • Asan Medical Center

    Seoul, 138-736, South Korea

  • B. P .Poddar Hospital & Medical Research Ltd.

    Kolkata, West Bengal, 700053, India

  • Beijing Chao-Yang Hospital

    Beijing, 100020, China

  • Cancer Hospital of Chinese Academy of Medical Science

    Beijing, 100021, China

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032, China

  • Geetanjali Medical College and Hospital

    Jaipur, 313002, India

  • Government Medical College & Hospital

    Nagpur, 440009, India

  • Harbin Medical University Cancer Hospital

    Harbin, 150081, China

  • J K Cancer Institute

    Kanpur, 208005, India

  • Keelung Chang Gung Memorial Lover's Lake Branch

    Keelung, 204, Taiwan

  • King George Medical University

    Lucknow, 226003, India

  • M N J Institute of Oncology and Regional Cancer Centre

    Hyderabad, 500004, India

  • Maharaj Nakom Chiangmai Hospital

    Chiang Mai, 50200, Thailand

  • Mansoura University Faculty of Medicine

    Dakahlia, 35516, Egypt

  • Naresuan University Hospital

    Phitsanulok, 65000, Thailand

  • National Cancer Center

    Goyang, 10408, South Korea

  • National Cancer Institute, Cairo University

    Cairo, 11796, Egypt

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • Navy General Hospital

    Beijing, 100037, China

  • Noble Hospital Pvt Ltd

    Pune, 411013, India

  • Pamela Youde Nethersole Eastern Hospital

    Hong Kong, 999077, Hong Kong

  • Peking Union Medical College Hospital

    Beijing, 100730, China

  • Perpetual Succour Hospital (Cebu)

    Cebu City, 6000, Philippines

  • Prince of Wales Hospital

    Shatin, 999077, Hong Kong

  • Pristine Hospital

    Bengaluru, 560086, India

  • Queen Mary Hospital

    Hong Kong, 999077, Hong Kong

  • Rajiv Gandhi Government General Hospital

    Chennai, 600003, India

  • Renji Hospital Shanghai Jiaotong Univesrity School of Medicine

    Shanghai, 200001, China

  • Ruby Hall Clinic

    Pune, 411001, India

  • Samsung Medical Center

    Seoul, 135-710, South Korea

  • Severance Hospital

    Seoul, 120-752, South Korea

  • Shanghai Changzheng Hospital

    Shanghai, 200003, China

  • Shanghai Ninth People's Hospital

    Shanghai, 200011, China

  • Shanghai Ninth People's Hospital

    Shanghai, 200125, China

  • Shatabdi Hospital, Nashik

    Nashik, 422002, India

  • Sichuan Cancer Hospital

    Chengdu, 610041, China

  • Songklanagarind Hospital

    Songkhla, 90110, Thailand

  • Srinagarind Hospital

    Muang, 40002, Thailand

  • St. Luke's Medical Center

    Quezon City, 1102, Philippines

  • Sujan Surgical Cancer Hospital

    Amravati, 444606, India

  • Sun Yat-Sen University Cancer Center

    Guangzhou, 510060, China

  • Taichung Veterans General Hospital

    Taichung, 407, Taiwan

  • The Catholic University of Korea, Seoul St.Mary's Hospital

    Seoul, 137-701, South Korea

  • The First Affiliated Hospital Of Bengbu Medical College

    Bengbu, 233004, China

  • The First Hospital of Jilin University

    Changchun, 130021, China

  • Tongji Hospital, Tongji University

    Wuhan, 430030, China

  • Tri-Service General Hospital

    Taipei, 11490, Taiwan

  • West China Hospital

    Chengdu, 610042, China

  • Wuhan Union Hospital

    Wuhan, 430022, China

  • Zhejiang Cancer Hospital

    Hangzhou, 310022, China

  • the 81th Hospital of PLA

    Nanjing, 210002, China