Image Guided Intensity Modulated Reirradiation (IG-IMRT) With Cetuximab for Locoregionally Confined Recurrent Head and Neck Squamous Cell Carcinoma

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00934518
• Date of registration: 07/07/2009
• Primary sponsor: Penn State University
• Public title: Image Guided Intensity Modulated Reirradiation (IG-IMRT) With Cetuximab for Locoregionally Confined Recurrent Head and Neck Squamous Cell Carcinoma
• Scientific title: Image Guided Intensity Modulated Reirradiation With Concurrent Cetuximab in the Treatment of Locoregionally Confined Relapsed Squamous Cell Carcinoma of the Head and Neck
• Date of first enrolment: July 2009
• Target sample size: 30
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00934518
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Heath B Mackley, MD
• Affiliation: Penn State Hershey Cancer Institute

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients must have a pathologically confirmed recurrence (reappearance of previously
cleared) squamous cell cancer in the upper aerodigestive tract or a second squamous
cell primary. Patients may have experienced more than one recurrence as long as the
first recurrence occurred =6 months following the end of the prior RT.

- The recurrence or second primary must be confined to the head and neck above the
clavicles (loco-regional recurrence).

- The majority (=75%) of the tumor volume must have been in areas previously irradiated
to =45 Gy. The previous irradiation must not exceed a maximum of 75 Gy.

- Patients must be at least 6 months from prior radiation therapy.

- If a resection is performed after the diagnosis of recurrence and before enrollment,
either microscopic or macroscopic disease must be present (i.e. positive margins or
gross residual).

- Karnofsky Performance Status 60-100.

- Granulocytes = 1500/mm3, platelets = 100,000/mm3, bilirubin = 1.5 mg/dl, creatinine =
1.5 mg/dl, within 6 weeks prior to registration.

- Must be able to submit previous radiation records (simulation and portal film if
available) in order to assure that cord tolerance is not exceeded.

- Patients must sign a study-specific informed consent form prior to study entry.

- The patient must be between the ages of 18 and 75.

Exclusion Criteria:

- Distant metastases.

- Completely resected recurrence with negative margins.

- Other concurrent invasive malignancies.

- Prior invasive malignancy unless disease free for at least two years (prior in situ
malignancies are permissible).

- Intercurrent medical illnesses which would impair patient tolerance to therapy or
limit survival.

- Pregnant and nursing women are excluded because of the potential teratogenic effects
and potential unknown effects on nursing newborns.

- Previous treatment with cetuximab.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Squamous Cell Cancer of the Head and Neck

Intervention(s)

Drug: Cetuximab

Radiation: Radiation

Primary Outcome(s)

To estimate the incidence rate of acute and late toxicities associated with combined cetuximab and image guided intensity modulated reirradiation in patients with recurrent squamous cell cancer of the head and neck. [Time Frame: 5 years]

Secondary Outcome(s)

To determine the pattern of disease progression in treated patients. [Time Frame: 5 years]

To estimate the median and one-year, disease-free, and overall survival rates of the treated patients. [Time Frame: 5 years]

To identify the impact of cetuximab and image guided intensity modulated reirradiation on patients' quality of life. [Time Frame: 5 years]

Secondary ID(s)

PSHCI 08-066

Source(s) of Monetary Support

Please refer to primary and secondary sponsors