CETUXIMAB Given for 3 Weeks as Neoadjuvant Treatment in Locally Advanced Tongue Cancer ; A NEW PARADIGM OF TREATMENT
NCT01760811 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2013-01-04
Summary
To compare the Disease free survival (DFS) rate of a preoperative cetuximab treatment followed by operation and postoperative radiation-cisplatin-cetuximab treatment paradigm for advanced oral cavity cancer, , with the DFS rate of historical controls (from the RTOG 9501 and EORTC 22931 studies in which treatment was with surgery followed by radiotherapy and cisplatin) with a similar stage of the disease.
Conditions
Interventions
- DRUG
-
Erbitux,merck serono
cetuximab loading dosage 400mg/m2 followed by weekly 250mg/m2 2 weeks
Sponsors & Collaborators
-
Kaplan Medical Center
collaborator OTHER -
Meir Medical Center
collaborator OTHER -
Rabin Medical Center
lead OTHER
Principal Investigators
-
Aron Popovtzer, MD · Tel Aviv University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-01-31
- Primary Completion
- 2015-12-31
- Completion
- 2017-12-31
Countries
- Israel
Study Locations
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