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

This study is not yet open for participant recruitment.
Verified January 2013 by popovtzer aron, Rabin Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01760811
First Posted: January 4, 2013
Last Update Posted: January 4, 2013
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.
Collaborators:
Kaplan Medical Center
Meir Medical Center
Information provided by (Responsible Party):
popovtzer aron, Rabin Medical Center
  Purpose
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.

Condition Intervention Phase
Squamous Cell Carcinoma Drug: Erbitux,merck serono Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by popovtzer aron, Rabin Medical Center:

Primary Outcome Measures:
  • PROGRESSION FREE SURVIVAL [ Time Frame: 2 YEARS ]
    : 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


Secondary Outcome Measures:
  • Adverse event rate [ Time Frame: 2 years ]
    To evaluate the frequency and severity of adverse events (AEs) for this treatment paradigm.

  • Biomarker prediction [ Time Frame: 2 years ]
    To evaluate the correlation between changes in expression levels of several biomarkers related to cell apoptosis and tumor progression: the endothelial growth factor receptor pathway, p53, human papilloma virus, BCL-2, BCL-X(L), and acid ceramidase - before and after treatment - with survival rates, PFS and response rates


Other Outcome Measures:
  • Micro -RNA [ Time Frame: 2 YEARS ]
    To evaluate the role of downregulation of microRNAs according to the outcome of treatment


Estimated Enrollment: 25
Study Start Date: January 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cetuximab ,neoadjuvant administration
Drug administration ,Cetuximab(merck Serono )given neoadjuvant ,3 courses prior surgery followed by post operatve radiation and Cetuximab
Drug: Erbitux,merck serono
cetuximab loading dosage 400mg/m2 followed by weekly 250mg/m2 2 weeks

Detailed Description:
This non-randomized, open-label, single center phase II study, will determine if patients with advanced oral tongue cancer that are treated with induction doses of cetuximab followed by treatment with radiation therapy concurrently with cetuximab and cisplatin (when indicated by positive margins or extra-capsular extension), will have improved PFS and improved survival and feasible toxicity, compared with patients treated in previous clinical trials (RTOG 9501 and EORTC 22931) with standard therapy: radiotherapy of 60 Gy with or without a 6-Gy boost (RTOG 9501) or 66 Gy (EORTC 22931) delivered through a conventional fractionation regimen of five once-daily sessions per week, and cisplatin in a dose of 100 mg/m2 on days 1, 22, and 43.. Twenty five patients will be recruited. Cetuximab treatment will be started (day 0) with 400 mg/m2 followed by two doses of 250 mg/m2 (once weekly on day 7 and 14). Surgery will be performed on day 31 followed by treatment with radiation therapy concurrently with cetuximab (250 mg/m2, once weekly) and cisplatin 35 mg/m2 (days 70-112; when indicated by positive margins or lymph nodes with extra-capsular extension). PET-CT and biopsies will be performed before starting with cetuximab, just before surgery and after chemo-cetuximab-RT to determine efficacy of treatment, and to compare the diagnostic properties of the PET-CT with that of the biopsies. The changes, before and after treatment with cetuximab, of protein levels in saliva, and tumor tissue and of microRNA levels in tumor tissue will be studied and correlated with PFS. The quality of life will be assessed. Data from clinical trials RTOG 9501 and EORTC 22931 will be used as historical controls.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. -

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760811


Contacts
Contact: Aron Popovtzer, MD 9729739378004 aronp@clalit.org.il
Contact: Dror Limon, MD 9729378004 drorl@clalt.org.il

Locations
Israel
Rabin Medical Center Not yet recruiting
Petah Tiqva, Israel, 49100
Contact: Aron Popovtzer, MD    9729378044    aronp@clalit.org.il   
Sub-Investigator: Dror Limon, MD         
Sub-Investigator: Salomon Stemmer, MD         
Sub-Investigator: Rafael Feinmesser, MD         
Sub-Investigator: Thomas Spitzer, MD         
Sub-Investigator: Gideon Bachar, MD         
Principal Investigator: Aron Popovtzer, MD         
Sponsors and Collaborators
Rabin Medical Center
Kaplan Medical Center
Meir Medical Center
Investigators
Principal Investigator: Aron Popovtzer, MD Tel Aviv University
  More Information

Responsible Party: popovtzer aron, Head of head and neck cancer unit, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01760811     History of Changes
Other Study ID Numbers: RMC0766
First Submitted: January 2, 2013
First Posted: January 4, 2013
Last Update Posted: January 4, 2013
Last Verified: January 2013

Keywords provided by popovtzer aron, Rabin Medical Center:
tongue
Squamous cell carcinoma
locally advanced
cetuximab

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Cetuximab
Antineoplastic Agents