Clinical trial · Interventional
A Study of Erlotinib (Tarceva) in Participants With Resected Head and Neck Squamous Cell Cancer
Phase III Randomized, Controlled Trial of Erlotinib (Tarceva) as Maintenance Therapy in Patients With Squamous Cell Carcinoma of the Head and Neck Treated With Resection and Radiotherapy With or Without Concomitant Chemotherapy With Curative Aim
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated because recruitment was too slow.
Summary
Brief summary (as posted)
This two-arm study will compare the efficacy and safety of erlotinib (Tarceva) versus placebo in participants with resected head and neck squamous cell cancer who are receiving concurrent chemoradiotherapy or radiotherapy alone. Participants will be randomized to receive either erlotinib 150 milligrams (mg) orally (PO) once daily or placebo for 1 year until disease progression or unacceptable toxicity.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erlotinib | Drug | Erlotinib | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| Standard of care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Erlotinib
- description
- Participants treated with surgical resection and chemoradiotherapy or radiotherapy alone will receive erlotinib tablets as 150 mg PO daily for 1 year until disease progression or intolerable toxicity.
- interventionNames
- Drug: Erlotinib
- Other: Standard of care
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Participants treated with surgical resection and chemoradiotherapy or radiotherapy alone will receive placebo treatment for 1 year until disease progression or intolerable toxicity.
- interventionNames
- Drug: Placebo
- Other: Standard of care
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults greater than or equal to (≥) 18 years of age * Curatively treated head and neck squamous cell cancer with T3-T4 and/or N2-N3 pathology, with or without other findings of poor prognosis such as extranodal extension, positive resection margins, and perineural or vascular involvement * Eastern Cooperative Oncology Group (ECOG) status of 0 to 2 Exclusion Criteria: * Macroscopic residual disease after surgery * Previous treatment with anti-epidermal growth factor receptor (anti-EGFR) targeted therapies
References
Publications (0)
Data not yet available