NCT00933387

Brief Summary

Surgical resection followed by concurrent chemoradiotherapy is considered as the standard of care for locally advanced OSCC (LAOSCC). Although the treatment could provide prompt local control, but it is also associated with high incidence of distant failure. Systemic chemotherapy given either before (neoadjuvant) or after (adjuvant) definitive local treatment has been extensively evaluated to improve the clinical outcome in LAOSCC. Regimens of taxane/cisplatin-based combinations have been shown to improve the treatment outcome of patients with locally advanced head and neck squamous cell carcinoma (HNSCC) in neoadjuvant setting. Recently, cetuximab (Erbitux®), a monoclonal antibody against epidermal growth factor receptor (EGFR), has also been proven to be an efficient agent for advanced and/or refractory HNSCC with acceptable toxicity profiles. In current study, we shall evaluate the feasibility, efficacy and safety of a triplet bio-chemotherapy consisting of cetuximab, paclitaxel, and cisplatin followed by cetuximab-based concurrent bio-radiotherapy (CBRT) in patients with LAOSCC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 3, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 7, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

May 4, 2016

Status Verified

October 1, 2009

Enrollment Period

1.8 years

First QC Date

July 3, 2009

Last Update Submit

May 3, 2016

Conditions

Oral Cancer

Keywords

oral squamous cell carcinomaneoadjuvant bio-chemotherapyconcurrent bio-radiotherapybiomarker

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint is the overall response rate after completion of the assigned treatment.

    18 weeks

Secondary Outcomes (1)

  • Secondary endpoints include the response rate after neoadjuvant therapy, progression-free survival, overall survival, biomarker prediction, and toxicity.

    >2 years

Study Arms (1)

open label

EXPERIMENTAL

an open-labelled, single-arm

Drug: Cetuximab,Paclitaxel,Cisplatin

Interventions

Cetuximab,Paclitaxel,CisplatinDRUG

Cetuximab 500 mg/m2 iv infusion (120 min for the 1st infusion, 90 min for the 2nd , and 60 min for the subsequent) Paclitaxel 120 mg/m2 3-hour iv infusion Cisplatin 50 mg/m2 2-hour iv infusion

open label

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • High-risk, locally advanced (TxN2b\~3 or unresectable T4, M0) OSCC
  • Histologically confirmed squamous cell carcinoma
  • Performance status: Eastern Cooperative Oncology Group performance status (ECOG) 0-1
  • age 18 years or older, less than 70 years of age
  • Having signed informed consent
  • Measurable disease by CT or MRI
  • Adequate hematologic, hepatic and renal function

You may not qualify if:

  • Prior radiotherapy for targeted lesions, chemotherapy, EGFR pathway targeting therapy
  • Prior surgery for cancer except for the purpose of diagnostic biopsy
  • Concomitant active 2nd malignancies or disease-free of malignancies \< 3 years before the study except adequately treated in situ cervical cancer, or non-melanoma skin cancer
  • Concomitant anticancer therapies within the past 28 days
  • Severe cardiopulmonary diseases and other systemic disease under poor control
  • Uncontrolled chronic neuropathy
  • Women who are positive of pregnancy, or in breast-feeding
  • Known allergy to any study treatment
  • Legal incapacity
  • Significant disease which, in the investigator's opinion, would exclude the patient from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Health Research of Institutes, Taiwan Cooperative Oncology Group

Tainan, Taiwan

Location

MeSH Terms

Conditions

Mouth NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

CetuximabTP protocol

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

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

Study Officials

  • J Y Chang, M.D.

    National Health Research of Institutes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2009

First Posted

July 7, 2009

Study Start

September 1, 2009

Primary Completion

July 1, 2011

Study Completion

November 1, 2013

Last Updated

May 4, 2016

Record last verified: 2009-10

Locations

TW(1)