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

Primary Purpose

Locally Advanced Malignant Neoplasm, Oral Cancer, Oropharyngeal Carcinoma

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Neo-adjuvant Erbitux-based chemotherapy
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Malignant Neoplasm focused on measuring Oral cancer, Oropharyngeal cancer, Induction chemotherapy, Targeted chemotherapy, Surgery, Radiotherapy, Effects of Chemotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eye & Ear Hospital of Fudan University
  • Fudan University Shanghai Cancer Center
  • Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University
  • Shanghai Changzheng Hospital
  • Shanghai First People's Hospital
  • Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • Tongji University Dongfang Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neo-adjuvant Erbitux-based chemotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Disease Free Survival
Disease Free Survival (DFS) rates (1, 2, 3, 5 years)
Locoregional Control rates
Locoregional Control rates (LCR) (1, 3, 5 years)
Overall Survival
Overall Survival (OS) rate (3, 5 years)

Full Information

First Posted
September 22, 2011
Last Updated
May 2, 2020
Sponsor
Shanghai Jiao Tong University School of Medicine
Collaborators
Fudan University, Tongji University, Second Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01440270
Brief Title
Neo-adjuvant Erbitux-based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer
Official Title
Neo-adjuvant Erbitux-based Chemotherapy Followed by Surgery and Radiotherapy for Locally Advanced Oral/Oropharyngeal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
Collaborators
Fudan University, Tongji University, Second Military Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Malignant Neoplasm, Oral Cancer, Oropharyngeal Carcinoma
Keywords
Oral cancer, Oropharyngeal cancer, Induction chemotherapy, Targeted chemotherapy, Surgery, Radiotherapy, Effects of Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neo-adjuvant Erbitux-based chemotherapy
Arm Type
Experimental
Arm Description
Neo-adjuvant Erbitux-based chemotherapy before surgery: Erbitux, Docetaxel, Cisplatin.
Intervention Type
Drug
Intervention Name(s)
Neo-adjuvant Erbitux-based chemotherapy
Other Intervention Name(s)
Followed by surgery and radiotherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Pathological Complete Response
Description
To evaluate pathological Complete Response (pCR) after neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy.
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Disease Free Survival
Description
Disease Free Survival (DFS) rates (1, 2, 3, 5 years)
Time Frame
5 years
Title
Locoregional Control rates
Description
Locoregional Control rates (LCR) (1, 3, 5 years)
Time Frame
5 years
Title
Overall Survival
Description
Overall Survival (OS) rate (3, 5 years)
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen-ping Zhang, MD, PhD
Organizational Affiliation
Department of Oral and Maxillofacial Surger, Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University
Official's Role
Study Chair
Facility Information:
Facility Name
Eye & Ear Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanghai First People's Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Tongji University Dongfang Hospital
City
Shanghai
State/Province
Shanghai
Country
China

12. IPD Sharing Statement

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

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