Radiotherapy With Cisplatin vs. Docetaxel-cetuximab in HNSCC: ERCC1 Biomarker Enrichment and Interaction Design ((UPCI)13-056)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02128906|
Recruitment Status : Recruiting
First Posted : May 1, 2014
Last Update Posted : April 9, 2020
The goal of this clinical research study is to learn which chemotherapy combination may be more effective in treating locally advanced head and neck squamous cell carcinoma (HNSCC). The side effects of these combinations will also be studied.
This study treatment consists of intensity-modulated radiation therapy (IMRT) and concurrent chemotherapy. For study chemotherapy, patients will be randomized between cisplatin or the combination of docetaxel and cetuximab. Subjects will be stratified depending on HPV status and the presence of ERCC-1 [4F9] in the tumor prior to randomization. The study will evaluate cisplatin vs. docetaxel-cetuximab in the overall population, and test which radiation and chemotherapy combination works best in relationship to how much ERCC-1 [4F9] is expressed in a tumor.
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Carcinoma||Drug: Cisplatin Radiation: IMRT Drug: Docetaxel Drug: Cetuximab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Phase II Study of Definitive Radiotherapy With Concurrent Cisplatin vs. Docetaxel-cetuximab in Locally Advanced Head and Neck Squamous Cell Carcinoma: an ERCC1 Biomarker Enrichment and Interaction Design|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
Active Comparator: Cisplatin-IMRT
Cisplatin 40 mg/m2 weekly x 7; IMRT: once daily, M-F, 7 weeks (70 Gy)
Cisplatin 40 mg/m2 weekly x 7
Other Name: Platinol
IMRT: once daily, M-F, 7 weeks (70 Gy)
Active Comparator: Docetaxel-Cetuximab-IMRT
Docetaxel 15 mg/m2 weekly x 7; Cetuximab 400 mg/m2 load, one week prior to IMRT; Cetuximab 250 mg/m2 weekly x 7; IMRT: once daily, M-F, 7 weeks (70 Gy)
IMRT: once daily, M-F, 7 weeks (70 Gy)
Docetaxel 15 mg/m2 weekly x 7
Other Name: Taxotere
Cetuximab 400 mg/m2 load, one week prior to IMRT Cetuximab 250 mg/m2 weekly x 7
Other Name: Erbitux
- Evaluate the efficacy of radiotherapy with concurrent docetaxel-cetuximab vs. cisplatin in patients with locally advanced HNSCC and increased tumoral ERCC1 expression, as measured by time to progression (TTP) [ Time Frame: 5 years ]
- Evaluate the efficacy of radiotherapy with concurrent docetaxel-cetuximab vs. cisplatin in patients with PULA HNSCC and decreased/normal tumoral ERCC1 expression, as measured by TTP [ Time Frame: 5 years ]
- Evaluate the efficacy of radiotherapy with concurrent docetaxel-cetuximab vs. cisplatin in all patients irrespective of ERCC1 status, as measured by TTP [ Time Frame: 5 years ]
- Prospectively validate the candidate cutpoint for decreased/normal vs. increased ERCC1 [4F9] expression in patients treated with cisplatin-IMRT [ Time Frame: 5 years ]
- Prospectively investigate two sets of radiologic interpretive criteria, including RECIST 1.1 and integrated PET/CT, for the designation of complete response (CR), and to compare the ability of the two CR classifications to accurately predict 2-year TTP. [ Time Frame: 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128906
|Contact: Karen Holeva||(412) firstname.lastname@example.org|
|United States, Pennsylvania|
|University of Pittsburgh||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15232|
|Contact: Karen Holeva, RN 412-623-1275 email@example.com|
|Principal Investigator:||Heath Skinner, MD||University of Pittsburgh|