Cetuximab Given for 3 Weeks as Neoadjuvant Treatment Followed by 6 Weeks of Cetuximab+RT Post Surgery in Locally Advanced Squamous Cell Carcinoma of the Tongue ; A New Paradigm of Treatment
Study Identifier:
22931
CT.gov Identifier:
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
Terminated/Withdrawn
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Study Summary
To study cetuximab given for 3 weeks as neoadjuvant treatment followed by 6 weeks of cetuximab+radiation therapy post surgery in locally advanced squamous cell carcinoma of the tongue.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Squamous Cell Carcinoma
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
I/II
Sex
Female & Male
Age
18 - 80 Years
Study Drug
Drug: Cetuximab ,neoadjuvant administration
Study Status
Indicates the current recruitment status or the expanded access status
Terminated/Withdrawn
Requirements information
Inclusion criteria
- Ages Eligible for Study: 18 Years to 80 Years
- Genders Eligible for Study: Both
- Pathologically confirmed, previously untreated, resectable squamous cell carcinoma of the tongue at disease stage III or IV
- Age > or = 18 to < or = 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. -
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START San Antonio
San Antonio, TX, United States, 78229
Investigator
Kyriakos Papadopoulos
Status
Recruiting
Condition(s) Treated at Site
Squamous Cell Carcinoma
Location
START Madrid, Spain (FJD)
Madrid, Spain, 28040
Investigator
Victor Moreno Garcia
Status
Recruiting
Condition(s) Treated at Site
Squamous Cell Carcinoma
Location
START Midwest
Grand Rapids, MI, United States, 49546
Investigator
Manish Sharma
Status
Recruiting
Condition(s) Treated at Site
Squamous Cell Carcinoma
Location
START Barcelona
Barcelona, Spain, 08023
Investigator
Tatiana Hernandez Guerrero
Status
Recruiting
Condition(s) Treated at Site
Squamous Cell Carcinoma