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



Status:Withdrawn
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/14/2019
Start Date:July 2009
End Date:July 2011

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Image Guided Intensity Modulated Reirradiation With Concurrent Cetuximab in the Treatment of Locoregionally Confined Relapsed Squamous Cell Carcinoma of the Head and Neck

The standard treatment for head and neck cancer relapses in previously irradiated patients is
controversial. Reirradiation has had some success, but many patients still die from their
disease. Cetuximab is helpful in relapsed head and neck cancer, and it improves the
effectiveness of radiation in some head and neck cancer patients. But, it has not been
studied with reirradiation. The purpose of this study is to see the effects, both good and
bad, of reirradiation with cetuximab.


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.
We found this trial at
1
site
Hershey, Pennsylvania 17033
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Hershey, PA
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