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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01760811 on ClinicalTrials.gov