Who is sponsoring NCT01884623?

NCT01884623 is sponsored by Gustave Roussy, Cancer Campus, Grand Paris.

What drugs are being tested in NCT01884623?

Interventions in NCT01884623: Cetuximab, Methotrexate.

What condition does NCT01884623 study?

NCT01884623 studies Head Neck Cancer Squamous Cell Recurrent.

Is NCT01884623 still recruiting?

NCT01884623 is currently completed. Last updated 9 February 2024.

Last reviewed 2024-02-09 · How we verify

NCT01884623: ELAN-UNFIT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase III Trial Comparing Methotrexate and Cetuximab in First-line Treatment of Recurrent and/or Metastatic Squamous Cell Head and Neck Cancer

Completed Phase 3 Last updated 9 February 2024

What this trial tests

Phase 3 trial testing Cetuximab in Head Neck Cancer Squamous Cell Recurrent in 82 participants. Completed in 12 October 2021.

Timeline

6 November 2013

Primary endpoint
12 October 2021

12 October 2021

Quick facts

Lead sponsor	Gustave Roussy, Cancer Campus, Grand Paris
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	82
Start date	6 November 2013
Primary completion	12 October 2021
Estimated completion	12 October 2021
Sites	1 location across France

Drugs / interventions tested

Cetuximab (cetuximab) — full drug profile →
Methotrexate — full drug profile →

Conditions studied

Head Neck Cancer Squamous Cell Recurrent — all drugs for Head Neck Cancer Squamous Cell Recurrent →

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris — full company profile →

Who can join

70 and older, any sex, with Head Neck Cancer Squamous Cell Recurrent. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To test whether cetuximab improves efficacy/tolerance as compared to methotrexate in first line treatment of unfit patients ³ 70 years old with recurrent and /or metastatic HNSCC. Efficacy assessed by failure free survival

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Evidence-Based Treatment Options in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck.
Argiris A, Harrington KJ, Tahara M, Schulten J, et al · · 2017 · cited 107× · PMID 28536670 · DOI 10.3389/fonc.2017.00072
Treatment of Elderly Patients with Squamous Cell Carcinoma of the Head and Neck.
Szturz P, Vermorken JB. · · 2016 · cited 72× · PMID 27630826 · DOI 10.3389/fonc.2016.00199
The Older Adult With Locoregionally Advanced Head and Neck Squamous Cell Carcinoma: Knowledge Gaps and Future Direction in Assessment and Treatment.
Maggiore R, Zumsteg ZS, BrintzenhofeSzoc K, Trevino KM, et al · · 2017 · cited 43× · PMID 28602414 · DOI 10.1016/j.ijrobp.2017.02.022
Considerations for clinical trial design in older adults with cancer.
Soto-Perez-De-Celis E, Lichtman SM. · · 2017 · cited 23× · PMID 28814118 · DOI 10.1080/13543784.2017.1369043
Cancer Stem Cells: Metabolic Characterization for Targeted Cancer Therapy.
Kaur J, Bhattacharyya S. · · 2021 · cited 21× · PMID 34804950 · DOI 10.3389/fonc.2021.756888
Management of Older Adults with Locally Advanced Head and Neck Cancer.
Dickstein DR, Lehrer EJ, Hsieh K, Hotca A, et al · · 2022 · cited 18× · PMID 35681789 · DOI 10.3390/cancers14112809
Cetuximab versus methotrexate in first-line treatment of older, frail patients with inoperable recurrent or metastatic head and neck cancer (ELAN UNFIT): a randomised, open-label, phase 3 trial.
Guigay J, Ortholan C, Vansteene D, Cupissol D, et al · · 2024 · cited 4× · PMID 38432247 · DOI 10.1016/s2666-7568(23)00284-2
Perspectives on cancer care in older patients in France.
Hauchecorne M, Pierro M, Brain E, Bringuier M, et al · · 2020 · cited 4× · PMID 33082853 · DOI 10.3332/ecancer.2020.1103

Verify or expand the search:

Other trials of Cetuximab

Trials testing the same drug.

NCT07441681 — Comparing Radiation Plus Cetuximab to Radiation Plus Chemotherapy in People With Head and Neck Cancer Who Cannot Receive · Phase 3 · not yet recruiting
NCT06418724 — Neoadjuvant PD-1 Inhibitor and EGFR Inhibitor in Locally Advanced Cutaneous Squamous Cell Carcinoma · Phase 2 · not yet recruiting
NCT07411599 — Dual Administration Of Intraperitoneal And Intravenous TROP2-Directed CAR-NK With TGF-Beta Receptor 2 (TGFBR2) Knock Out · Phase 1, PHASE2 · not yet recruiting
NCT07318389 — ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer · EARLY_PHASE1 · not yet recruiting
NCT07490119 — Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer · Phase 2 · not yet recruiting

Other Gustave Roussy, Cancer Campus, Grand Paris trials

Trials by the same sponsor.

NCT07303387 — Efficacy and Safety of the Valemetostat in Patients With Selected Solid Tumors. · Phase 2 · not yet recruiting
NCT07159451 — A Short-term Preoperative, Evaluating Activity and Safety of Elacestrant Monotherapy as Compared to Elacestrant + Ovaria · Phase 2 · recruiting
NCT06781996 — A Study to Determine the Efficacy of a Digital Self-management Support Tool to Improve the Quality of Life During Adjuva · Phase 3 · recruiting
NCT07016230 — Study Investigating Tarlatamab (AMG 757) in Patients With Metastatic/Locally Advanced Small-Cell Lung Cancer (SCLC) and · Phase 2 · recruiting
NCT06902883 — Study on the Effectiveness and Comfort of Innovative Solutions for the Internal Transport of Patients in Wheelchairs in · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01884623 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gustave Roussy, Cancer Campus, Grand Paris
Last refreshed: 9 February 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01884623.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing