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Protocol No.0920RTOGPrincipal InvestigatorSnider, James
PhasePhase III (Cancer Control)
Age GroupAdult
TitleA PHASE III STUDY OF POSTOPERATIVE RADIATION THERAPY (IMRT) +/- CETUXIMAB FOR LOCALLY-ADVANCED RESECTED HEAD AND NECK CANCER
DescriptionThe purpose of this study is to compare the effects, good and/or bad, of radiation therapy alone vs. radiation therapy and cetuximab on locally-advanced resected head and neck cancer to find out which is better.
TreatmentCetuximab with or without Radiation
Key Eligibility1. Pathologically (histologically) proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma NOS, etc.) of the head/neck (oral cavity, oropharynx or larynx).

2. Clinical stage T1, N1-2 or T2-4a, N0-2, M0 including no distant metastases.

3. Gross total resection of the primary tumor with curative intent must be completed within 7 weeks of registration

4. Zubrod Performance Status of 0-1 within 2 weeks prior to registration

5. Age greater than or equal to 18.

6. CBC/differential obtained within 4 weeks prior to registration on study, with adequate bone marrow function.

7. Adequate hepatic function.

8. Adequate renal function.

9. Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential

10. Lab assessments are required within 2 weeks prior to the start of registration:
-Na, K, Cl, glucose, Ca, Mg, and albumin

11. Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control

12. Patients must provide study specific informed consent prior to study entry, including consent for mandatory tissue submission for EGFR and for oropharyngeal patients, HPV analyses.

*For information about the inclusion/exclusion criteria please, call study site contact(s)*

Applicable Disease SitesEsophagus
Larynx
Lip, Oral Cavity and Pharynx
Therapies InvolvedRadiotherapy
Drugs InvolvedCetuximab
Erbitux (Cetuximab)
StatusOpen
Treatment TypeTreatment
ClinicalTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT00956007
ContactGreenebaum Cancer Center Nancy Kennedy, R.N., BSN Phone:410-328-2513
Pager:410-328-2337 #8235
Email:nkennedy@umm.edu
Caroline Poff Phone:410-369-5264
Pager:
Email:cpoff@umm.edu
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