Clinical trial · Interventional
Re-irradiation With Fractionated Stereotactic Radiosurgery Plus Cetuximab in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck
NCT01104922CI-TRIAL-00056516completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial examines survival and toxicity in previously irradiated patients with squamous cell carcinoma of the head and neck (SCCHN) treated with radiosurgery and cetuximab and to evaluate the acute and late toxicities associated with the above therapy.
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 |
|---|---|---|---|
| Squamous Cell Carcinoma of the Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| Stereotactic radiosurgery | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cetuximab and stereotactic radiosurgery
- interventionNames
- Drug: Cetuximab
- Device: Stereotactic radiosurgery
Primary outcomes (3)
- measure
- 1-year Local Progression-free Survival (PFS)
- timeFrame
- At 1-year
- description
- Progression (response as assessed by subjective interpretation of the first PET-CT) per Response Evaluation Criteria in Solid Tumors (RECIST v1.0) was defined as greater than 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum and longest diameter recorded since the baseline measurements or the appearance of 1 or more new lesion(s). If the measurable disease was restricted to a solitary lesion, the protocol specified that neoplastic nature should be confirmed by cytology and histology.
- measure
- 1-year Locoregional Progression-free Survival (PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven recurrent squamous cell carcinoma of the head and neck (SCCHN), who has received prior radiotherapy with or without chemotherapy. New primary is allowed if location is in a previously irradiated field. Biopsy is recommended for each recurrence; but is not mandated per study. This will be at the discretion of the principal investigator. * Prior radiation dose of at least 60 Gy. * Disease confined to locoregional site and can be encompassed in a stereotactic radiosurgery "portal" * Tumor must be deemed to be inoperable or unresectable either by clinical or radiographic criteria. These criteria include encasement of great vessels, vertebral invasion or undue peri-operative risk. * Prior surgery for recurrent or new SCCHN is allowed in previously irradiated patients. A minimum of 4 weeks should elapse between any surgery and treatment on study. However, high risk pathologic features should be present, such as positive margins, positive lymphadenopathy, perineural or angiolymphatic invasion. Measurable disease must be present for assessment of response. * Karnofsky performance status \> 60 (ECOG 0-2) * Prior treatment with an EGFR Inhibitor is allowed if it was a part of prior curative therapy and was completed at least 30 days prior to commencement of study therapy * Any number of prior chemotherapy regimens are allowed * Measurable disease on imaging studies (MRI, CT, PET-CT or physical exam) * Age \> 18 * Estimated life expectancy \> 12 weeks * No prior radiation therapy or chemotherapy within 1 month of study enrollment * No prior chemotherapy or targeted therapy within the previous 4 weeks * ANC \> 1000, PLT\>75,000, Serum creatinine\<2.5 mg/dL, Bilirubin \<1.5 x upper limits of normal (ULN) * Diabetes must be controlled prior to PET-CT scanning (blood glucose \<200 mg/dL) * Ability to provide written informed consent Exclusion Criteria: * Evidence of distant metastasis on upright chest x-ray (CXR), computed tomography (CT) or other staging studies * History of any cancer other than SCCHN (except non-melanoma skin cancer or carcinoma in situ of the cervix) within the last 5 years. * Patients in their reproductive age group should use an effective method of birth control. Patients who are breast-feeding, or have a positive pregnancy test will be excluded from the study * Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the investigator * Concurrent serious infection * History of known hypersensitivity to cetuximab or similar agents
References
Publications (1)
- DERIVEDVargo JA, Ferris RL, Ohr J, Clump DA, Davis KS, Duvvuri U, Kim S, Johnson JT, Bauman JE, Gibson MK, Branstetter BF, Heron DE. A prospective phase 2 trial of reirradiation with stereotactic body radiation therapy plus cetuximab in patients with previously irradiated recurrent squamous cell carcinoma of the head and neck. Int J Radiat Oncol Biol Phys. 2015 Mar 1;91(3):480-8. doi: 10.1016/j.ijrobp.2014.11.023. Epub 2015 Jan 30. PMID 25680594