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Neo-adjuvant Erbitux-based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01440270
Recruitment Status : Completed
First Posted : September 26, 2011
Last Update Posted : May 5, 2020
Sponsor:
Collaborators:
Fudan University
Tongji University
Second Military Medical University
Information provided by (Responsible Party):
Lai-ping Zhong, Shanghai Jiao Tong University School of Medicine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Locally Advanced Malignant Neoplasm Oral Cancer Oropharyngeal Carcinoma Drug: Neo-adjuvant Erbitux-based chemotherapy Phase 2

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neo-adjuvant Erbitux-based Chemotherapy Followed by Surgery and Radiotherapy for Locally Advanced Oral/Oropharyngeal Cancer
Study Start Date : August 2011
Actual Primary Completion Date : October 2014
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Neo-adjuvant Erbitux-based chemotherapy
Neo-adjuvant Erbitux-based chemotherapy before surgery: Erbitux, Docetaxel, Cisplatin.
 Drug: Neo-adjuvant Erbitux-based chemotherapy

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

Other Name: Followed by surgery and radiotherapy


Outcome Measures
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Primary Outcome Measures :
  1. Pathological Complete Response [ Time Frame: Up to 6 months ]
    To evaluate pathological Complete Response (pCR) after neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy.


Secondary Outcome Measures :
  1. Disease Free Survival [ Time Frame: 5 years ]
    Disease Free Survival (DFS) rates (1, 2, 3, 5 years)

  2. Locoregional Control rates [ Time Frame: 5 years ]
    Locoregional Control rates (LCR) (1, 3, 5 years)

  3. Overall Survival [ Time Frame: 5 years ]
    Overall Survival (OS) rate (3, 5 years)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

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 adequately treated 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 study.
  • 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
  • Pregnancy (confirmed by serum or urine β-HCG) or lactation period
  • Severe cardiac disease such as heart failure, clinically relevant cardiac dysrhythmias, coronary artery disease or myocardial infarction within the last 12 months
Contacts and Locations
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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): NCT01440270


Locations
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China, Shanghai
Eye & Ear Hospital of Fudan University
Shanghai, Shanghai, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai, China
Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai, China
Shanghai Changzheng Hospital
Shanghai, Shanghai, China
Shanghai First People's Hospital
Shanghai, Shanghai, China
Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai, China
Tongji University Dongfang Hospital
Shanghai, Shanghai, China
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Fudan University
Tongji University
Second Military Medical University
Investigators
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Study Chair: Chen-ping Zhang, MD, PhD Department of Oral and Maxillofacial Surger, Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University
More Information
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Responsible Party: Lai-ping Zhong, Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01440270    
Other Study ID Numbers: EMR 622022237
First Posted: September 26, 2011    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Keywords provided by Lai-ping Zhong, Shanghai Jiao Tong University School of Medicine:
Oral cancer
Oropharyngeal cancer
Induction chemotherapy
Targeted chemotherapy
 Surgery
Radiotherapy
Effects of Chemotherapy
Additional relevant MeSH terms:
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Neoplasms
Oropharyngeal Neoplasms
Mouth Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
 Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Mouth Diseases
Cetuximab
Antineoplastic Agents, Immunological
Antineoplastic Agents