DAHANCA 26. Randomized study of chemotherapy with or without cetuximab for advanced head and neck cancer

DAHANCA 26. A phase II unblinded, randomized study of paclitaxel and capecitabine with or without cetuximab as first line treatment of recurrent or metastatic squamous cell head and neck cancer (HNSCC) - DAHANCA 26

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001023-80-DK

Enrollment

Registered

2015-01-05

Start date

2015-02-09

Completion date

Unknown

Last updated

2021-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent or metastatic squamous cellular head and neck cancer MedDRA version: 20.0 Level: PT Classification code 10060121 Term: Squamous cell carcinoma of head and neck System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Erbitux Product Name: Cetuximab Pharmaceutical Form: Infusion INN or Proposed INN: CETUXIMAB CAS Number: 205923-56-4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: e

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Recurrent or metastatic squamaous cellular head and neck cancer Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 88 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: Poor performance or organ function

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare response to standard chemotherapy with paclitaxel and capecitabine with the same treatment plus cetuximab;Secondary Objective: Progression free survival Overall survival Toxicity Quality of life;Primary end point(s): Response (RECIST 1.1);Timepoint(s) of evaluation of this end point: Best response (confirmed). Evaluation every third series (9 weekly)	—

Secondary

Measure	Time frame
Secondary end point(s): Progresion free survival Overall survivial Toxicity Quality of life;Timepoint(s) of evaluation of this end point: Toxicity: Every doctor visit Quality of life: baseline, 9 weeks, 3 months after end of treatment	—

Countries

Denmark

Contacts

Public ContactDAHANCA secretary

Danish Head and Neck Cancer Group (DAHANCA)

jens@oncology.dk4578462629

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026