Nasopharyngeal CancerPhase 3NCT01074021
Nimotuzumab in Combination With Chemoradiation for Nasopharyngeal Cancer
A Phase 3 study testing Nimotuzumab in people with Nasopharyngeal Cancer, run by Biotech Pharmaceutical Co., Ltd. at 24 sites in China.
Trial summary
Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical trials are ongoing globally to evaluate nimotuzumab in different indications. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Cancer
- What is being tested?
- Nimotuzumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 24 sitesChina
- Study dates
- Oct 2009to Aug 2016
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Joined the study voluntary and signed informed consent form
- Age 18-70，both genders.
- Nasopharyngeal cancer was confirmed by pathology.
- Nasopharyngeal cancer 2008 Stages: Ⅲ/Ⅳa.
- Primary lesions can measurable.
- Karnofsky Performance Scale >70.
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- Life expectancy of more than 6 months.
- Use of an effective contraceptive method for women when there is a risk of pregnancy during the study.
- Haemoglobin≥100g/L ,WBC ≥4×109/L, platelet count≥100×109/L
- Hepatic function:ALAT、ASAT< 1.5 x ULN, TBIL< 1.5 x ULN
- Renal function: Creatinine < 1.5 x ULN
Who cannot join
- Evidence of distant metastasis
- Primary lesions or lymph node have been operated (except of operation for biopsy)
- Previous radiotherapy
- Received other anti EGFR monoclonal antibody treatment
- Previous chemotherapy or immunization therapy
- Other malignant tumor (except of Non-melanoma Skin Cancer or carcinoma in situ of cervix)
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- Participation in other interventional clinical trials within 1 month
- Peripheral neuropathy is more than I stage
- Pregnant or breast-feeding women and women who refused to take contraceptive method
- History of serious allergic or allergy
- History of Serious lung or heart disease
- Refused or can't signed informed consent form
- Drug abuse or alcohol addiction
- Personality or psychiatric disease, and persons without capacity for civil conduct or persons with limited capacity for civil conduct
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
China24 sites
Cancer Institute & Hospital.Chinese Academy of Medical Sciences
Beijing, 100021
Peking Union Medical College Hospital
Beijing, 100032
Beijing Cancer Hospital
Beijing, 100142
The General Hospital of the People's Liberation Army
Beijing, 100853
Sichuan Province Cancer Hospital
Chengdu, Sichuan
West China School of Medicine/West China Hospital of Sichuan University (WCSM/WCH)
Chengdu, Sichuan
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Fujian Provincial Cancer Hospital
Fuzhou, Fujian
The Affiliated Cancer Hospital of Guangzhou Medical Hospital
Guangzhou, Guangdong, 510095
The Affiliated Cancer Hospital of Haerbin Medical University
Haerbin, Heilongjiang, 150081
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Shandong Caner Hospital
Jinan, Shandong, 250117
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
The Affiliated Renji Hosptial of ShanghaiJiao Tong University
Shanghai, 200001
Fudan University Shanghai Cancer Center
Shanghai
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110003
Liaoning Province Cancer Hospital
Shenyang, Liaoning, 110042
The Fourth Hebei Province Hospital
Shijiazhuang, Hebei, 050011
Tianjin Cancer Hospital
Tianjin, 300060
Hubei Province Caner Hospital
Wuhan, Hubei, 430079
Wuhan Union Hospital
Wuhan, Hubei
Xiamen First Hospital
Xiamen, Fujian, 361003
Affiliated Tumor Hospital of Guangxi Medical University
Xining Shequ, Guangxi, 530021
Henan Cancer Hospital
Zhengzhou, Henan, 450008
About this study
Official title: A Prospective,Randomized,Double-Blind,Controlled,Multicenter,Phase III Study of Nimotuzumab in Combination With Chemotherapy and Radiotherapy for Patients With Local Advanced Nasopharyngeal Cancer
Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical trials are ongoing globally to evaluate nimotuzumab in different indications. Nimotuzumab has been granted approval for use in squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal cancer in different countries. The Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the clinical efficacy, and safety of the combination of Nimotuzumab administered concomitantly with chemotherapy and radiotherapy in patients with advanced nasopharyngeal cancer.
Read the detailed description
Patients with advanced nasopharyngeal cancer will be randomized to 2 arms. The patients in experimental arm will be treated with Nimotuzumab which will be used concurrently with radiotherapy and chemotherapy. The chemotherapy regimen were Cisplatin monotherapy. The active comparator arm will be administered chemotherapy and radiotherapy only. The dose and regimen were the same with experiment arm. The patients'hematopoietic , hepatic and renal function tests will be monitored weekly, a physical exam and reassessment of the tumor will be performed at the first and the fourth month, and followup every six months to evaluate the survival index in three years after the study.
- Conditions
- Nasopharyngeal Cancer
- Being tested
- Nimotuzumab, placebo plus chemoradiotherapy
- Keywords
- Nimotuzumab, Nasopharyngeal cancer, chemoradiation
- Medical subject headings
- Nasopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimotuzumabDrug
Nimotuzumab:(200mg/w,weekly, 7-8 weeks, one week before radiotherapy)
Radiotherapy:
IMRT: Nasopharynx: GTV 66-78. 2Gy,CTV1 60-64Gy,CTV2 54-60Gy.30-34 times, 2.20-2.30Gy/time,once a day, 5 days/w, 6-7 weeks. Neck: lymph node positive, GTVn 60-70Gy, once a day, 5 days/w, 6-7weeks; lymph node negative, CTVn50-55Gy, once a day, 5 days/w, 6-7 weeks.
CRT: Nasopharynx, 70-(76-80)Gy, 35-(38-40)times, 2Gy/time, once a day, 5 days/w, 6-8weeks. If disease residual when radiotherapy finished could increase the dose appropriate. Neck: lymph node positive, 64-70 Gy, 32-35 times, 2 Gy/time, once a day, 5 days/w, 6-7 weeks; lymph node negative, 50-56 Gy, 25-28 times,2 Gy/time, once a day, 5 days/w, 5-6weeks cisplatin
Chemotherapy:
Cisplatin (100 mg/m2,1 time/21d, 3 times，on days 2, 23, 44 during the radiotherapy)
placebo plus chemoradiotherapyDrug
Placebo treatment:4 bottles/w,weekly, 7-8 weeks, one week before radiotherapy
Radiotherapy:
IMRT: Nasopharynx: GTV 66-78. 2Gy,CTV1 60-64Gy,CTV2 54-60Gy.30-34 times, 2.20-2.30Gy/time,once a day, 5 days/w, 6-7 weeks. Neck: lymph node positive, GTVn 60-70Gy, once a day, 5 days/w, 6-7weeks; lymph node negative, CTVn50-55Gy, once a day, 5 days/w, 6-7 weeks.
CRT: Nasopharynx, 70-(76-80)Gy, 35-(38-40)times, 2Gy/time, once a day, 5 days/w, 6-8weeks. If disease residual when radiotherapy finished could increase the dose appropriate. Neck: lymph node positive, 64-70 Gy, 32-35 times, 2 Gy/time, once a day, 5 days/w, 6-7 weeks; lymph node negative, 50-56 Gy, 25-28 times,2 Gy/time, once a day, 5 days/w, 5-6weeks cisplatin
Chemotherapy: Cisplatin (100 mg/m2,1 time/21d, 3 times，on days 2, 23, 44 during the radiotherapy)
| Study group | Role | What they receive |
|---|---|---|
| Nimotuzumab plus chemoradiotherapy | Experimental | Not described Receives: Drug: Nimotuzumab |
| placebo plus chemoradiotherapy | Placebo comparator | Not described Receives: Drug: placebo plus chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the local-regional control rates of the disease in the advanced nasopharyngeal cancer patients subject to the treatment with Nimotuzumab in combination with chemoradiation
Measured: 3 months after the Nimotuzumab treatment finished
To determine the safety of the treatment with Nimotuzumab in combination with chemoradiation
Measured: within study period
Secondary outcomes (2)
To determine the Disease-free survival、Tumor control probability、Distant recurrence rate in the patients subject to the treatment at years 1,2,3
Measured: 3 year
To determine the Progression free suivival、Diease free survival、Overall survival in the patients subject to the treatment
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startOct 2009
- Primary completionMay 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CancerStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotech Pharmaceutical Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074021
- Sponsor's protocol ID
- BT-CT-001
- Status last verified
- Aug 2015
- First submitted
- 21 Feb 2010
- Last updated
- 30 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective,Randomized,Double-Blind,Controlled,Multicenter,Phase III Study of Nimotuzumab in Combination With Chemotherapy and Radiotherapy for Patients With Local Advanced Nasopharyngeal Cancer
- ClinicalTrials.gov ID
- NCT01074021
- Acronym / sponsor ID
- BT-CT-001
- Conditions
- Nasopharyngeal Cancer
- Keywords
- Nimotuzumab, Nasopharyngeal cancer, chemoradiation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Biotech Pharmaceutical Co., Ltd.University, hospital or other
- Study start
- Oct 2009
- Primary completion
- May 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 24 Feb 2010 (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.
Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical trials are ongoing globally to evaluate nimotuzumab in different indications. Nimotuzumab has been granted approval for use in squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal cancer in different countries. The Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the clinical efficacy, and safety of the combination of Nimotuzumab administered concomitantly with chemotherapy and radiotherapy in patients with advanced nasopharyngeal cancer.
Detailed description
Patients with advanced nasopharyngeal cancer will be randomized to 2 arms. The patients in experimental arm will be treated with Nimotuzumab which will be used concurrently with radiotherapy and chemotherapy. The chemotherapy regimen were Cisplatin monotherapy. The active comparator arm will be administered chemotherapy and radiotherapy only. The dose and regimen were the same with experiment arm. The patients'hematopoietic , hepatic and renal function tests will be monitored weekly, a physical exam and reassessment of the tumor will be performed at the first and the fourth month, and followup every six months to evaluate the survival index in three years after the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nimotuzumab plus chemoradiotherapy | Experimental | Drug: Nimotuzumab |
| placebo plus chemoradiotherapy | Placebo comparator | Drug: placebo plus chemoradiotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Joined the study voluntary and signed informed consent form
- Age 18-70，both genders.
- Nasopharyngeal cancer was confirmed by pathology.
- Nasopharyngeal cancer 2008 Stages: Ⅲ/Ⅳa.
- Primary lesions can measurable.
Key exclusion criteria (14 listed)
- Evidence of distant metastasis
- Primary lesions or lymph node have been operated (except of operation for biopsy)
- Previous radiotherapy
- Received other anti EGFR monoclonal antibody treatment
- Previous chemotherapy or immunization therapy
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 |
|---|---|---|
| NimotuzumabNimotuzumab:(200mg/w,weekly, 7-8 weeks, one week before radiotherapy) Radiotherapy: IMRT: Nasopharynx: GTV 66-78. 2Gy,CTV1 60-64Gy,CTV2 54-60Gy.30-34 times, 2.20-2.30Gy/time,once a day, 5 days/w, 6-7 weeks. Neck: lymph node positive, GTVn 60-70Gy, once a day, 5 days/w, 6-7weeks; lymph node negative, CTVn50-55Gy, once a day, 5 days/w, 6-7 weeks. CRT: Nasopharynx, 70-(76-80)Gy, 35-(38-40)times, 2Gy/time, once a day, 5 days/w, 6-8weeks. If disease residual when radiotherapy finished could increase the dose appropriate. Neck: lymph node positive, 64-70 Gy, 32-35 times, 2 Gy/time, once a day, 5 days/w, 6-7 weeks; lymph node negative, 50-56 Gy, 25-28 times,2 Gy/time, once a day, 5 days/w, 5-6weeks cisplatin Chemotherapy: Cisplatin (100 mg/m2,1 time/21d, 3 times，on days 2, 23, 44 during the radiotherapy) | Drug | Nimotuzumab plus chemoradiotherapy |
| placebo plus chemoradiotherapyPlacebo treatment:4 bottles/w,weekly, 7-8 weeks, one week before radiotherapy Radiotherapy: IMRT: Nasopharynx: GTV 66-78. 2Gy,CTV1 60-64Gy,CTV2 54-60Gy.30-34 times, 2.20-2.30Gy/time,once a day, 5 days/w, 6-7 weeks. Neck: lymph node positive, GTVn 60-70Gy, once a day, 5 days/w, 6-7weeks; lymph node negative, CTVn50-55Gy, once a day, 5 days/w, 6-7 weeks. CRT: Nasopharynx, 70-(76-80)Gy, 35-(38-40)times, 2Gy/time, once a day, 5 days/w, 6-8weeks. If disease residual when radiotherapy finished could increase the dose appropriate. Neck: lymph node positive, 64-70 Gy, 32-35 times, 2 Gy/time, once a day, 5 days/w, 6-7 weeks; lymph node negative, 50-56 Gy, 25-28 times,2 Gy/time, once a day, 5 days/w, 5-6weeks cisplatin Chemotherapy: Cisplatin (100 mg/m2,1 time/21d, 3 times，on days 2, 23, 44 during the radiotherapy) | Drug | placebo plus chemoradiotherapy |
Primary outcome
To determine the local-regional control rates of the disease in the advanced nasopharyngeal cancer patients subject to the treatment with Nimotuzumab in combination with chemoradiation
Time frame: 3 months after the Nimotuzumab treatment finished
To determine the safety of the treatment with Nimotuzumab in combination with chemoradiation
Time frame: within study period
2 secondary outcomes
To determine the Disease-free survival、Tumor control probability、Distant recurrence rate in the patients subject to the treatment at years 1,2,3
Time frame: 3 year
To determine the Progression free suivival、Diease free survival、Overall survival in the patients subject to the treatment
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nimotuzumab in people with Nasopharyngeal Cancer, run by Biotech Pharmaceutical Co., Ltd. at 24 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 11 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 30 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
To determine the local-regional control rates of the disease in the advanced nasopharyngeal cancer patients subject to the treatment with Nimotuzumab in combination with chemoradiation (time frame: 3 months after the Nimotuzumab treatment finished). The study lists 2 primary outcomes in all. 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 30 Oct 2015.