Neo-adjuvant Erbitux-based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer
This study is currently recruiting participants.
Verified April 2012 by Shanghai Jiao Tong University School of Medicine
Sponsor:
Shanghai Jiao Tong University School of Medicine
Collaborators:
Fudan University
Tongji University
Second Military Medical University
Information provided by (Responsible Party):
Lai-ping Zhong, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01440270
First received: September 22, 2011
Last updated: April 5, 2012
Last verified: April 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Locally Advanced Malignant Neoplasm Oral Cancer Oropharyngeal Carcinoma |
Drug: Neo-adjuvant Erbitux-based chemotherapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Neo-adjuvant Erbitux-based Chemotherapy Followed by Surgery and Radiotherapy for Locally Advanced Oral/Oropharyngeal Cancer |
Resource links provided by NLM:
Drug Information available for:
Phenylephrine
Phenylephrine hydrochloride
Oxymetazoline
Oxymetazoline hydrochloride
Cetuximab
U.S. FDA Resources
Further study details as provided by Shanghai Jiao Tong University School of Medicine:
Primary Outcome Measures:
- Pathological Complete Response [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]To evaluate pathological Complete Response (pCR) after neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy.
Secondary Outcome Measures:
- Disease Free Survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]Disease Free Survival (DFS) rates (1, 2, 3, 5 years)
- Locoregional Control rates [ Time Frame: 5 years ] [ Designated as safety issue: No ]Locoregional Control rates (LCR) (1, 3, 5 years)
- Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]Overall Survival (OS) rate (3, 5 years)
- Toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]All Adverse Events（AEs），including Serious Adverse Events（SAEs），Exposure of All study drugs & radiation
| Estimated Enrollment: | 121 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | February 2017 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01440270
Contacts
| Contact: Chen-ping Zhang, MD | +86-21-23271699 ext 5161 | zhang.chenping@hotmail.com |
Locations
| China, Shanghai | |
| Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University | Recruiting |
| Shanghai, Shanghai, China | |
| Contact: Lai-ping Zhong, MD, PhD +86-21-23271699 ext 5160 zhonglaiping@163.com | |
| Principal Investigator: Lai-ping Zhong, MD, PhD | |
| Fudan University Shanghai Cancer Center | Recruiting |
| Shanghai, Shanghai, China | |
| Contact: Qing-hai Ji | |
| Principal Investigator: Qing-hai Ji | |
| Eye & Ear Hospital of Fudan University | Recruiting |
| Shanghai, Shanghai, China | |
| Contact: Liang Zhou | |
| Principal Investigator: Liang Zhou | |
| Shanghai First People's Hospital | Recruiting |
| Shanghai, Shanghai, China | |
| Contact: Pin Dong | |
| Principal Investigator: Pin Dong | |
| Shanghai Changzheng Hospital | Recruiting |
| Shanghai, Shanghai, China | |
| Contact: Yun-fu Zhao | |
| Principal Investigator: Yun-fu Zhao | |
| Tongji University Dongfang Hospital | Active, not recruiting |
| Shanghai, Shanghai, China | |
| Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Recruiting |
| Shanghai, Shanghai, China | |
| Contact: Ji-fang Ren | |
| Principal Investigator: Ji-fang Ren | |
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Fudan University
Tongji University
Second Military Medical University
Investigators
| 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
No publications provided
| Responsible Party: | Lai-ping Zhong, Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01440270 History of Changes |
| Other Study ID Numbers: | EMR 622022237 |
| Study First Received: | September 22, 2011 |
| Last Updated: | April 5, 2012 |
| Health Authority: | China: Ethics Committee China: Science and Technology Commission of Shanghai Municipality |
Keywords provided by Shanghai Jiao Tong University School of Medicine:
|
Oral cancer Oropharyngeal cancer Induction chemotherapy Targeted chemotherapy |
Surgery Radiotherapy Effects of Chemotherapy |
Additional relevant MeSH terms:
|
Neoplasms Carcinoma Mouth Neoplasms Lip Neoplasms Oropharyngeal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Head and Neck Neoplasms Neoplasms by Site Mouth Diseases Stomatognathic Diseases Lip Diseases |
Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Pharyngeal Diseases Otorhinolaryngologic Diseases Adjuvants, Immunologic Cetuximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013