Radiotherapy With Cisplatin vs. Docetaxel-cetuximab in HNSCC: ERCC1 Biomarker Enrichment and Interaction Design

Summary

Participation Requirements

Description

If randomized to the cisplatin arm, you will receive cisplatin, 40 mg/m2, administered intravenously (IV) once a week (+/- 2 days) for 7 weeks. Per investigator discretion, if radiation continues beyond 7 weeks due to technical factors (not toxicity delays), an 8th dose of concurrent cisplatin may b...

If randomized to the cisplatin arm, you will receive cisplatin, 40 mg/m2, administered intravenously (IV) once a week (+/- 2 days) for 7 weeks. Per investigator discretion, if radiation continues beyond 7 weeks due to technical factors (not toxicity delays), an 8th dose of concurrent cisplatin may be added. It is strongly preferred that cisplatin be administered on Monday, Tuesday, or Wednesday of each treatment week to maximize overlap with radiation; administration on Thursday or Friday for logistical purposes will be noted however will not constitute a protocol violation. Cisplatin can be given either before or after the radiation therapy fraction that is given on the same day. If a dose of cisplatin is omitted when radiotherapy is ongoing, it will not be made up or added to the end of treatment. The omitted dose and the reason for the omission should be recorded in the site's source documentation. If radiotherapy is held, cisplatin should be held during the treatment break and resumed when radiation restarts. In this case, the cisplatin dose is not considered skipped or omitted, but delayed. If you are randomized to arm you will receive cetuximab, 250 mg/m2, IV over 60 minutes on a weekly schedule (+/- 2 days). . Cetuximab may be administered either before or after the radiation fraction that is given on the same day. Docetaxel will be administered at least 30 minutes following cetuximab. It is not permitted to make up missed doses of cetuximab or docetaxel. If a radiation therapy treatment break occurs, cetuximab should be held. When radiation restarts, cetuximab should resume. It is strongly preferred that cetuximab be administered on Monday, Tuesday, or Wednesday of each treatment week to maximize overlap with radiation; administration on Thursday or Friday for logistical purposes will be noted however will not constitute a protocol violation. Cetuximab will be given once a week (+/- 2 days) for a total of 7 doses concurrent with radiation therapy and docetaxel.

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