Brief Summary

Epidermal growth factor receptor（EGFR） is a potential target for new anticancer therapy in head and neck squamous cell carcinoma, because blocking the EGFR by a monoclonal antibody results in inhibition of the stimulation of the receptor, therefore, in inhibition of cell proliferation, enhanced apoptosis, and reduced angiogenesis, invasiveness and metastases. The study hypothesis is that neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy for locally advanced oral/oropharyngeal cancer could benefit the patients on prognosis. The endpoints of this study are the pathological complete response after neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy, the survival rate, and the safety.

Trial Health

On Track

Trial Health Score

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

Enrollment

145

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Aug 2011

Longer than P75 for phase_2

Geographic Reach

1 country

7 active sites

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

5.5 years study duration

Study Start

First participant enrolled

August 1, 2011

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2011

Completed

4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2011

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed

2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed

Last Updated

May 5, 2020

Status Verified

May 1, 2020

Enrollment Period

3.2 years

First QC Date

September 22, 2011

Last Update Submit

May 2, 2020

Conditions

Locally Advanced Malignant Neoplasm Oral Cancer Oropharyngeal Carcinoma

Keywords

Oral cancerOropharyngeal cancerInduction chemotherapyTargeted chemotherapySurgeryRadiotherapyEffects of Chemotherapy

Outcome Measures

Primary Outcomes (1)

Pathological Complete Response
To evaluate pathological Complete Response (pCR) after neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy.
Up to 6 months

Secondary Outcomes (3)

Disease Free Survival
5 years
Locoregional Control rates
5 years
Overall Survival
5 years

Study Arms (1)

Neo-adjuvant Erbitux-based chemotherapy

EXPERIMENTAL

Neo-adjuvant Erbitux-based chemotherapy before surgery: Erbitux, Docetaxel, Cisplatin.

Drug: Neo-adjuvant Erbitux-based chemotherapy

Interventions

Neo-adjuvant Erbitux-based chemotherapyDRUG

Name/Substance: Erbitux Formulation: 2 mg/ml or 5 mg/ml Dose: 400 mg/m\^2 initial, and then 250 mg/m\^2 weekly Route: Intravenous infusion Frequency \& treatment mode: Weekly Duration: 6 weeks Name/Substance: Docetaxel Formulation: Liquid (20 mg/2 ml) Dose: 75 mg/m\^2 Route: Intravenous infusion Frequency \& treatment mode: Day 1, every 3 weeks Duration: 2 cycles (6 weeks) Name/Substance: Cisplatin Formulation: Powder (30 mg) Dose: 75 mg/m\^2 Route: Intravenous infusion Frequency \& treatment mode: Day 1, every 3 weeks Duration: 2 cycles (6 weeks) Arms: Neo-adjuvant Erbitux-based chemotherapy

Also known as: Followed by surgery and radiotherapy

Neo-adjuvant Erbitux-based chemotherapy

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Written informed consent prior to any study activities
Age 18-75
Histological/cytological and iconography confirmed squamous-celled oral/oropharyngeal cancer
Stage Ⅲ/Ⅳa (T1-2, N1-2, M0 or T3-4, N0-2, M0, AJCC 2010), operable disease
Karnofsky performance status (KPS) ≥ 70
Adequate hematologic function: Neutrophils ≥ 1,500/mm\^3, WBC \> 4,000/mm\^3, Hb \> 10 g/dL, platelet count \> 100,000/mm\^3
Hepatic function: ALAT/ASAT \< 2.5 times the upper limit of normal (ULN), bilirubin \< 1.5 x ULN
Renal function: serum creatinine \< 1.5 x ULN
Life expectancy ≥ 6 months

You may not qualify if:

Evidence of distant metastatic disease and other oropharyngeal cancers
Surgical procedure of the primary tumor or lymph nodes (except diagnostic biopsy) before study treatment
Previous radiotherapy for the primary tumor or lymph nodes
Previous exposure to epidermal growth factor - targeted therapy
Prior chemotherapy or immunotherapy for the primary tumor
Other previous malignancy within 5 years, except adequately treated non-melanoma skin cancer or pre-invasive carcinoma of the cervix
Any investigational agent prior to the 1st study medication
Peripheral neuropathy \> grade 1
Known grade 3 or 4 allergic reaction to any of the study treatment
Creatinine Clearance \< 30 ml/min
Know drug abuse / alcohol abuse
Legal incapacity or limited legal capacity
Active systemic infection
Medical or psychiatric illness, which in the investigators' opinions, would not permit the subject to complete or fully and completely understand the risks and potential complications of the study
Concurrent chronic systemic immune therapy or hormone therapy not indicated in the study protocol
+2 more criteria

Contact the study team to confirm eligibility.