Locally Advanced Malignant NeoplasmPhase 2NCT01440270
Neo-adjuvant Erbitux-based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer
A Phase 2 study testing Neo-adjuvant Erbitux-based chemotherapy in people with Locally Advanced Malignant Neoplasm and Oral Cancer, run by Shanghai Jiao Tong University School of Medicine at 7 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Malignant Neoplasm, Oral Cancer, Oropharyngeal Carcinoma
- What is being tested?
- Neo-adjuvant Erbitux-based chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 7 sitesChina
- Study dates
- Aug 2011to Feb 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Eye & Ear Hospital of Fudan University
Shanghai, Shanghai Municipality
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality
Shanghai First People's Hospital
Shanghai, Shanghai Municipality
Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Tongji University Dongfang Hospital
Shanghai, Shanghai Municipality
About this study
Official title: Neo-adjuvant Erbitux-based Chemotherapy Followed by Surgery and Radiotherapy for Locally Advanced Oral/Oropharyngeal Cancer
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.
Read the 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.
- Being tested
- Neo-adjuvant Erbitux-based chemotherapy
- Keywords
- Oral cancer, Oropharyngeal cancer, Induction chemotherapy, Targeted chemotherapy, Surgery, Radiotherapy, Effects of Chemotherapy
- Medical subject headings
- Mouth Neoplasms, Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neo-adjuvant Erbitux-based chemotherapyDrug
Also called Followed by surgery and radiotherapy
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
| Study group | Role | What they receive |
|---|---|---|
| Neo-adjuvant Erbitux-based chemotherapy | Experimental | Neo-adjuvant Erbitux-based chemotherapy before surgery: Erbitux, Docetaxel, Cisplatin. Receives: Drug: Neo-adjuvant Erbitux-based chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response
To evaluate pathological Complete Response (pCR) after neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy.
Measured: Up to 6 months
Secondary outcomes (3)
Disease Free Survival
Disease Free Survival (DFS) rates (1, 2, 3, 5 years)
Measured: 5 years
Locoregional Control rates
Locoregional Control rates (LCR) (1, 3, 5 years)
Measured: 5 years
Overall Survival
Overall Survival (OS) rate (3, 5 years)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2014
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University, Tongji University, Second Military Medical University
- Responsible party
- Principal investigator, Lai-ping Zhong, Shanghai Jiao Tong University School of Medicine
- Investigators
- Chen-ping Zhang, MD, PhD, Study chair, Department of Oral and Maxillofacial Surger, Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01440270
- Sponsor's protocol ID
- EMR 622022237
- Status last verified
- May 2020
- First submitted
- 22 Sep 2011
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neo-adjuvant Erbitux-based Chemotherapy Followed by Surgery and Radiotherapy for Locally Advanced Oral/Oropharyngeal Cancer
- ClinicalTrials.gov ID
- NCT01440270
- Acronym / sponsor ID
- EMR 622022237
- Keywords
- Oral cancer, Oropharyngeal cancer, Induction chemotherapy, Targeted chemotherapy, Surgery, Radiotherapy, Effects of Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Fudan University, Tongji University, Second Military Medical University
- Study start
- Aug 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 26 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neo-adjuvant Erbitux-based chemotherapy | Experimental | Drug: Neo-adjuvant Erbitux-based chemotherapyNeo-adjuvant Erbitux-based chemotherapy before surgery: Erbitux, Docetaxel, Cisplatin. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neo-adjuvant Erbitux-based chemotherapyAlso: Followed by surgery and radiotherapyName/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 | Drug | Neo-adjuvant Erbitux-based chemotherapy |
Primary outcome
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.
3 secondary outcomes
Disease Free Survival
Time frame: 5 years
Locoregional Control rates
Time frame: 5 years
Overall Survival
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen-ping Zhang, MD, PhD study chair
Department of Oral and Maxillofacial Surger, Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neo-adjuvant Erbitux-based chemotherapy in people with Locally Advanced Malignant Neoplasm and Oral Cancer, run by Shanghai Jiao Tong University School of Medicine at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2020.