Multimodality Risk Adapted Tx Including Induction Chemo for SCCHN Amenable to Transoral Surgery (NCT01612351) | Clinical Trial Compass
CompletedPhase 2
Multimodality Risk Adapted Tx Including Induction Chemo for SCCHN Amenable to Transoral Surgery
United States40 participantsStarted 2012-06
Plain-language summary
The purpose of this study is to see if a three method risk adapted design using induction chemotherapy, transoral surgery and radiation chemotherapy will lessen toxic effects and make treatment of squamous cell carcinoma of the head and neck (SCCHN) better.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Previously untreated, histologically proven primary squamous cell carcinoma arising in the oral cavity, oropharynx, or supraglottic larynx, and amenable to transoral approach
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (see Appendix C)
* Measurable disease as per Response Evaluation Criteria In Solid Tumors (RECIST1.1)
* Age ≥18 years
* Adequate bone marrow function as demonstrated by: Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3; Hgb \> 10 g/dL (use of transfusion to reach this threshold prior to study initiation is acceptable); Platelet count ≥ 100,000/mm3
* Adequate hepatic and renal function as demonstrated by: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN); Total serum bilirubin ≤1.5 mg/dL; Creatinine clearance (CrCL) ≥ 40ml/min as measured via Cockcroft-Gault
* Left ventricular ejection fraction (LVEF) must be \> the lower limit of normal (LLN) per institutional standards by either echocardiography or radionuclide-based multiple gated acquisition (MUGA)
* Negative serum human chorionic gonadotropin (β-hCG) pregnancy test within 72 hours of day 1 of induction chemotherapy in women of child-bearing potential
* All males and females of childbearing potential must agree to use adequate contraception during the study. Adequate contraception is defined as any medically recommended method (or combination of methods) as per standard of care. Females of non-childbearing…