Nasopharyngeal CarcinomaPhase 3NCT03837808
Radiotherapy Plus Concurrent Nimotuzumab or Cisplatin in Stage II-III Nasopharyngeal Carcinoma
A Phase 3 study testing Nimotuzumab and Cisplatin in people with Nasopharyngeal Carcinoma and Nasopharyngeal Neoplasms, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a Phase III trial to study the effectiveness of nimotuzumab versus cisplatin combined with intensity-modulated radiation therapy (IMRT) in treating patients with stage II-III nasopharyngeal carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma, Nasopharyngeal Neoplasms, Nasopharyngeal Diseases
- What is being tested?
- Nimotuzumab and Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 1 siteChina
- Study dates
- 11 Apr 2019to 11 Feb 2024
- 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
- Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
- histologically confirmed positive EGFR expression
- Stage II and III NPC patients（according to the 8th AJCC edition）
- Male and no pregnant female
- Age between 18-65
- Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL
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- Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <2.0×upper limit of normal (ULN)
- Adequate renal function: creatinine clearance ≥60 ml/min
- Satisfactory performance status: Karnofsky scale (KPS) > 70
- Without radiotherapy or chemotherapy
- Patients must give signed informed consent
Who cannot join
- Evidence of relapse or distant metastasis
- History of prior malignancy or previous treatment for NPC
- Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Rui-Hua Xu, MD,PhD
About this study
Official title: A Randomized Phase III Non-inferiority Study of Radiotherapy Plus Concurrent Nimotuzumab Versus Cisplatin in Stage II-III Nasopharyngeal Carcinoma
This is a Phase III trial to study the effectiveness of nimotuzumab versus cisplatin combined with intensity-modulated radiation therapy (IMRT) in treating patients with stage II-III nasopharyngeal carcinoma.
Read the detailed description
Scheme:
Eligible stage II and III NPC patients will first be stratified by institution, then randomized to 2 arms at 1:1 ratio.
- Arm Cisplatin: cisplatin 40mg/m2/week in concurrent with IMRT
- Arm nimotuzumab: nimotuzumab 200mg/week in concurrent with IMRT
- Conditions
- Nasopharyngeal Carcinoma, Nasopharyngeal Neoplasms, Nasopharyngeal Diseases, Head and Neck Neoplasm
- Being tested
- Nimotuzumab, Cisplatin
- Keywords
- nimotuzumab
- Medical subject headings
- Nasopharyngeal Carcinoma, Nasopharyngeal Neoplasms, Nasopharyngeal Diseases, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimotuzumabDrug
nimotuzumab 200mg/week in concurrent with IMRT, d1,d8,d15,d22,d29,d36 of RT
CisplatinDrug
cisplatin 40mg/m2/week in concurrent with IMRT, d1,d8,d15,d22,d29,d36 of RT
| Study group | Role | What they receive |
|---|---|---|
| Nimotuzumab | Experimental | nimotuzumab 200mg/week in concurrent with IMRT Receives: Drug: Nimotuzumab |
| Cisplatin | Active comparator | cisplatin 40mg/m2/week in concurrent with IMRT Receives: Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress-free survival (PFS)
Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.
Measured: 2 years
Secondary outcomes (4)
Overall Survival (OS)
The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.
Measured: 2 years
Locoregional Relapse-Free Survival (LRRFS)
The LRRFS is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit.
Measured: 2 years
Distant Metastasis-Free Survival (DMFS)
The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.
Measured: 2 years
Number of participants with adverse events
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start11 Apr 2019
- Primary completion11 Feb 2024 (estimated)
- Study completion11 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Guangdong Provincial People's Hospital, First Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Principal investigator, Ming-Yuan Chen, Sun Yat-sen University
- Investigators
- Ming-Yuan Chen, MD,PhD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837808
- Sponsor's protocol ID
- 2018-FXY-206
- Status last verified
- Nov 2022
- First submitted
- 26 Jan 2019
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Non-inferiority Study of Radiotherapy Plus Concurrent Nimotuzumab Versus Cisplatin in Stage II-III Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT03837808
- Acronym / sponsor ID
- 2018-FXY-206
- Conditions
- Nasopharyngeal Carcinoma, Nasopharyngeal Neoplasms, Nasopharyngeal Diseases, Head and Neck Neoplasm
- Keywords
- nimotuzumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Guangdong Provincial People's Hospital, First Affiliated Hospital, Sun Yat-Sen University
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 11 Feb 2024 (estimated)
- Study completion
- 11 Feb 2024 (estimated)
- First posted
- 12 Feb 2019 (actual)
- 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.
This is a Phase III trial to study the effectiveness of nimotuzumab versus cisplatin combined with intensity-modulated radiation therapy (IMRT) in treating patients with stage II-III nasopharyngeal carcinoma.
Detailed description
Scheme:
Eligible stage II and III NPC patients will first be stratified by institution, then randomized to 2 arms at 1:1 ratio.
- Arm Cisplatin: cisplatin 40mg/m2/week in concurrent with IMRT
- Arm nimotuzumab: nimotuzumab 200mg/week in concurrent with IMRT
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nimotuzumab | Experimental | Drug: Nimotuzumabnimotuzumab 200mg/week in concurrent with IMRT |
| Cisplatin | Active comparator | Drug: Cisplatincisplatin 40mg/m2/week in concurrent with IMRT |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
- histologically confirmed positive EGFR expression
- Stage II and III NPC patients（according to the 8th AJCC edition）
- Male and no pregnant female
- Age between 18-65
Key exclusion criteria (4 listed)
- Evidence of relapse or distant metastasis
- History of prior malignancy or previous treatment for NPC
- Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.
- Pregnancy or lactation
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/week in concurrent with IMRT, d1,d8,d15,d22,d29,d36 of RT | Drug | Nimotuzumab |
| Cisplatincisplatin 40mg/m2/week in concurrent with IMRT, d1,d8,d15,d22,d29,d36 of RT | Drug | Cisplatin |
Primary outcome
Progress-free survival (PFS)
Time frame: 2 years
Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.
4 secondary outcomes
Overall Survival (OS)
Time frame: 2 years
Locoregional Relapse-Free Survival (LRRFS)
Time frame: 2 years
Distant Metastasis-Free Survival (DMFS)
Time frame: 2 years
Number of participants with adverse events
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
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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.
Ming-Yuan Chen, MD,PhD principal investigator
Sun Yat-sen University
1 site 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 and Cisplatin in people with Nasopharyngeal Carcinoma and Nasopharyngeal Neoplasms, run by Sun Yat-sen University at 1 site 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 4 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 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
Contact Ming-Yuan Chen, MD,PhD (+86-20-87343361, chenmy@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress-free survival (PFS) (time frame: 2 years). 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 7 Nov 2022.