Overview

CETUXIMAB Given for 3 Weeks as Neoadjuvant Treatment in Locally Advanced Tongue Cancer ; A NEW PARADIGM OF TREATMENT

Status:
Unknown status

Trial end date:
2017-12-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 1/Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Rabin Medical Center

Collaborators:

Kaplan Medical Center
Meir Medical Center

Treatments:

Cetuximab

Criteria

Inclusion Criteria:

Pathologically confirmed, previously untreated, resectable squamous cell carcinoma of the
tongue at disease stage III or IV; Age ≥18 to ≤80; Eastern Cooperative Oncology Group
(ECOG) Performance status 0-1;willingto give written informed consent for participation in
this study -

Exclusion Criteria:

Any prior head and neck malignancy or other malignancy in the last 5 years but BCC; Prior
head and neck radiation; Documented evidence of distant metastases; Pregnancy or lactation;
Clinically significant cardiovascular disease; Known hypersensitivity to any of the
components of the treatment; Legal incapacity; Clinically relevant neuropathy; Any medical
or psychiatric illness which would compromise the patient's ability to tolerate this
treatment, or interfere with the study objectives. -