NCT01760811

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 4, 2013

Status Verified

January 1, 2013

Enrollment Period

2.9 years

First QC Date

January 2, 2013

Last Update Submit

January 2, 2013

Conditions

Squamous Cell Carcinoma

Keywords

tongueSquamous cell carcinomalocally advancedcetuximab

Outcome Measures

Primary Outcomes (1)

  • PROGRESSION FREE SURVIVAL

    : 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

    2 YEARS

Secondary Outcomes (2)

  • Adverse event rate

    2 years

  • Biomarker prediction

    2 years

Other Outcomes (1)

  • Micro -RNA

    2 YEARS

Study Arms (1)

Cetuximab ,neoadjuvant administration

OTHER

Drug administration ,Cetuximab(merck Serono )given neoadjuvant ,3 courses prior surgery followed by post operatve radiation and Cetuximab

Drug: Erbitux,merck serono

Interventions

Erbitux,merck seronoDRUG

cetuximab loading dosage 400mg/m2 followed by weekly 250mg/m2 2 weeks

Cetuximab ,neoadjuvant administration

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 -

You may not qualify if:

  • 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. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Aron Popovtzer, MD

    Tel Aviv University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aron Popovtzer, MD

CONTACT

9729739378004aronp@clalit.org.il

Dror Limon, MD

CONTACT

9729378004drorl@clalt.org.il

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of head and neck cancer unit

Study Record Dates

First Submitted

January 2, 2013

First Posted

January 4, 2013

Study Start

January 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2017

Last Updated

January 4, 2013

Record last verified: 2013-01

Locations

IL(1)