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Neoadjuvant Erbitux Based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer

Phase 2/Phase 3
18 Years
75 Years
Open (Enrolling)
Locally Advanced Malignant Neoplasm, Oral Cancer, Oropharyngeal Carcinoma, Effects of Chemotherapy

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Trial Information

Neoadjuvant Erbitux Based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer

The primary endpoint of this study is the pathological complete response after neo-adjuvant
Erbitux-based chemotherapy followed by surgery and radiotherapy. The second endpoint of this
study is the disease free survival rates (1, 2, 3, 5 years), locoregional control rates (1,
3, 5 years), overall survival rate (3, 5 years), and the safety.

Inclusion Criteria:

- Written informed consent prior to any study activities

- Age 18-75

- Histological/cytological and iconography confirmed squamous-celled oral/oropharyngeal

- 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

Exclusion Criteria:

- 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 non-melanoma skin cancer or
pre-invasive carcinoma of the cervix

- Any investigational agent prior to the 1st study medication

- Participation in another clinical study within the 30 days prior to Inclusion in this

- Peripheral neuropathy >grade 1

- Known grade 3 or 4 allergic reaction to any of the study treatment

- History of severe pulmonary or cardiac disease

- 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

- Pregnancy (confirmed by serum or urine β-HCG) or lactation period

- Severe cardiac disease such as heart failure, clinical relevant cardiac dysrhythmias,
coronary artery disease or myocardial infarction within the last 12 months

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathological Complete Response

Outcome Description:

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

Outcome Time Frame:

Up to 6 months

Safety Issue:


Principal Investigator

Chen-ping Zhang, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Department of Oral and Maxillofacial Surger, Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University


China: Ethics Committee

Study ID:




Start Date:

August 2011

Completion Date:

February 2017

Related Keywords:

  • Locally Advanced Malignant Neoplasm
  • Oral Cancer
  • Oropharyngeal Carcinoma
  • Effects of Chemotherapy
  • Oral cancer
  • Oropharyngeal cancer
  • Induction chemotherapy
  • Targeted chemotherapy
  • Surgery
  • Radiotherapy
  • Neoplasms
  • Carcinoma
  • Mouth Neoplasms
  • Lip Neoplasms
  • Oropharyngeal Neoplasms