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Re-irradiation With Fractionated Stereotactic Radiosurgery Plus Cetuximab in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck

Phase 2
18 Years
Open (Enrolling)
Squamous Cell Carcinoma of the Head and Neck

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Trial Information

Re-irradiation With Fractionated Stereotactic Radiosurgery Plus Cetuximab in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the 1-year progression-free survival (PFS) of previously irradiated patients with SCCHN treated with radiosurgery and cetuximab;

Outcome Description:

Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy); - Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Dwight Heron, FACP, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh


United States: Institutional Review Board

Study ID:

UPCI 06-093



Start Date:

July 2007

Completion Date:

December 2014

Related Keywords:

  • Squamous Cell Carcinoma of the Head and Neck
  • Re-irradiation with Fractionated Stereotactic Radiosurgery for Head and Neck
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms



University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213