Clinical trial · Interventional
Radiation Therapy and Cetuximab in Treating Patients With Recurrent Head and Neck Cancer
A Feasibility Study of Re-irradiation Using Stereotactic Body Radiation Therapy (SBRT) and Cetuximab for Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual
Summary
Brief summary (as posted)
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving stereotactic body radiation therapy together with cetuximab may kill more tumor cells. PURPOSE: This clinical trial is studying the side effects of radiation therapy given together with cetuximab and to see how well it works in treating patients with recurrent head and neck cancer.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cetuximab | Biological | Cetuximab | ALIAS |
| stereotactic body radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cetuximab
- description
- Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-5
- interventionNames
- Biological: cetuximab
- Radiation: stereotactic body radiation therapy
Primary outcomes (1)
- measure
- Grade 4-5 Toxicity as Assessed by NCI CTCAE v.30
- timeFrame
- Daily while on Treatment
Secondary outcomes (3)
- measure
- Feasibility as Assessed According to Ability to Deliver the Entire Treatment Regimen to 80% of Patients
- timeFrame
- 2 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the oral cavity, paranasal sinuses, nasopharynx, larynx, hypopharynx, or oropharynx * Medically or surgically inoperable disease or patient refuses surgery * Recurrent disease * Previously irradiated disease meeting the following criteria: * Prior radiotherapy completed \> 6 months from re-irradiation * Prior radiotherapy in the region of the study cancer that would result in overlap of radiation therapy fields * Majority of the recurrent tumor volume (\> 50%) received prior radiotherapy dose of 30-75 Gy * No distant metastatic disease PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 3 months * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 60 days after completion of study treatment * No prior allergic reaction to study drugs PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior surgical resection of the recurrent primary tumor and/or regional lymphatics
References
Publications (0)
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