Recurrent Nasopharyngeal CarcinomaPhase 2NCT03666221
Nimotuzumab for Recurrent Nasopharyngeal Carcinoma
A Phase 2 study testing Nimotuzumab in people with Recurrent Nasopharyngeal Carcinoma, run by Fujian Cancer Hospital at 1 site in China.
Trial summary
The study assessed the clinical efficacy, and safety of the combination of Nimotuzumab administered concomitantly with intensity modulated radiation therapy(IMRT) in patients with recurrent nasopharyngeal cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Recurrent Nasopharyngeal Carcinoma
- What is being tested?
- Nimotuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2014to 1 Nov 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with recurrent tumor in nasopharynx with or without relapse cervical lymph nodes more than 6 months after initial radical treatment.
- Recurrent nasopharyngeal cancer was confirmed by pathology, marginal recurrence can be diagnosed by imaging examinations.
- Age 18-70.
- At least one of the tumor lesions measurable.
- Functional Status: PS (ECOG) > 0-1.
- Normal Bone Marrow Function: White blood cell count > 4×109/L, hemoglobin >90g/L, and platelet count >100×109/L.
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- Normal Hepatic and Renal Function: Alanine Tminotransferase (ALT)/Aspartate Aminotransferase (AST) < 2.5 times the upper limit of normal (ULN), while total bilirubin (T-Bil) < 1.5 x ULN and serum creatinine < 1.5 x ULN.
- Life expectancy of more than 6 months.
- All the patients signed the informed consent.
- Follow up regularly and comply with test requirements.
Who cannot join
- Patients with recurrent cervical lymph nodes alone.
- Evidence of distant metastasis
- The relapse tumor has been treated with chemotherapy, radiotherapy, surgery, immunotherapy and other anti-tumor therapy.
- Creatinine clearance < 30ml/min
- Has received epidermal growth factor targeting therapy.
- Second malignancy within 5 years(except of Non-melanoma Skin Cancer or carcinoma in situ of cervix).
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- Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc.
- Active systemic infection.
- History of Serious lung or heart disease.
- Drug or alcohol addiction.
- Persons without capacity for civil conduct or persons with limited capacity for civil conduct.
- The patient has physical or mental disorders and is believed to be unable to fully or fully understand the possible complications of the study.
- To receive chronic systemic immunotherapy or hormone therapy other than this study.
- Women who are pregnant or breast feeding
- Participation in other drugs clinical trials within 1 month.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of radiation oncology, Fujian cancer hospital
Fuzhou, Fujian, 350014
SHAOJUN LIN, master, 0086-0591-62752225, linshaojun@yeah.net
About this study
Official title: An Open,Multicenter,Phase II Trial of Intensity Modulated Radiation Therapy Combined With Concurrent Nimotuzumab in Patient With Recurrent Nasopharyngeal Carcinoma
The study assessed the clinical efficacy, and safety of the combination of Nimotuzumab administered concomitantly with intensity modulated radiation therapy(IMRT) in patients with recurrent nasopharyngeal cancer.
Read the detailed description
The clinical efficacy of Nimotuzumab combined with radiotherapy has been shown in advanced nasopharyngeal cancer, which was significantly higher than radiotherapy alone. The efficacy of radiotherapy combined with Nimotuzumab has not been confirmed in recurrent nasopharyngeal cancer.In this study, Phase II clinical trials were performed. The patients were treated with Nimotuzumab which were used concurrently with IMRT. The efficacy and toxicity will be assessed.
- Conditions
- Recurrent Nasopharyngeal Carcinoma
- Being tested
- Nimotuzumab
- Keywords
- Nimotuzumab, IMRT, Radiation, Recurrent, Nasopharyngeal Carcinoma
- Medical subject headings
- Nasopharyngeal Carcinoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimotuzumabDrug
Also called Radiation
Drug: Nimotuzumab Radiation: Intensity Modulated Radiation Therapy
| Study group | Role | What they receive |
|---|---|---|
| Nimotuzumab plus IMRT | Experimental | Patients with recurrent nasopharyngeal carcinoma were given an initial dose of nimotuzumab (200 mg) 7days before receiving concurrent intensity modulated radiation therapy(IMRT) , folowing weekly nimotuzumab (200 mg/week) for totally 8 weeks concurrent with IMRT. Receives: Drug: Nimotuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response rate after Nimotuzumab concurrent with radiotherapy for recurrent NPC patients
The response status (Complete Response + Partial Response) was evaluated according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Complete response was defined as disappearance of all target lesions, and Partial response was defined as at least a 30% reduction in the sum of the longest diameter of target lesions, taking as reference the baseline study.
Measured: Three month after patients subject to the treatment
Toxicity of this combined treatment for recurrent NPC patients
Adverse events of this combined modality treatment were graded according to CTCAE (Common Terminology Criteria for Adverse Events) v3.0 criteria.Toxicity Criteria for Adverse Events version 3.0
Measured: Three month after patients subject to the treatment
Secondary outcomes (3)
Local Progression free survival
Measured: Three years
Disease-free survival
Defined as the time in month from all treatment were finished to the date of disease progress is observed.
Measured: Three years
Overall survival
Defined as the time in month from diagnosis of recurrent NPC to the date of death is observed or to last follow-up visit.
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start1 Nov 2014
- Primary completion1 Apr 2020 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe 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
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Collaborators
- Sun Yat-sen University, Jiangxi Provincial Cancer Hospital, Zhejiang Cancer Hospital, Fujian Medical University Union Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666221
- Sponsor's protocol ID
- NPC001.2
- Status last verified
- Sep 2018
- First submitted
- 10 Sep 2018
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open,Multicenter,Phase II Trial of Intensity Modulated Radiation Therapy Combined With Concurrent Nimotuzumab in Patient With Recurrent Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT03666221
- Acronym / sponsor ID
- NPC001.2
- Conditions
- Recurrent Nasopharyngeal Carcinoma
- Keywords
- Nimotuzumab, IMRT, Radiation, Recurrent, Nasopharyngeal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Collaborators
- Sun Yat-sen University, Jiangxi Provincial Cancer Hospital, Zhejiang Cancer Hospital, Fujian Medical University Union Hospital
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 11 Sep 2018 (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.
The study assessed the clinical efficacy, and safety of the combination of Nimotuzumab administered concomitantly with intensity modulated radiation therapy(IMRT) in patients with recurrent nasopharyngeal cancer.
Detailed description
The clinical efficacy of Nimotuzumab combined with radiotherapy has been shown in advanced nasopharyngeal cancer, which was significantly higher than radiotherapy alone. The efficacy of radiotherapy combined with Nimotuzumab has not been confirmed in recurrent nasopharyngeal cancer.In this study, Phase II clinical trials were performed. The patients were treated with Nimotuzumab which were used concurrently with IMRT. The efficacy and toxicity will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nimotuzumab plus IMRT | Experimental | Drug: NimotuzumabPatients with recurrent nasopharyngeal carcinoma were given an initial dose of nimotuzumab (200 mg) 7days before receiving concurrent intensity modulated radiation therapy(IMRT) , folowing weekly nimotuzumab (200 mg/week) for totally 8 weeks 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 (10 listed)
- Patients with recurrent tumor in nasopharynx with or without relapse cervical lymph nodes more than 6 months after initial radical treatment.
- Recurrent nasopharyngeal cancer was confirmed by pathology, marginal recurrence can be diagnosed by imaging examinations.
- Age 18-70.
- At least one of the tumor lesions measurable.
- Functional Status: PS (ECOG) > 0-1.
Key exclusion criteria (15 listed)
- Patients with recurrent cervical lymph nodes alone.
- Evidence of distant metastasis
- The relapse tumor has been treated with chemotherapy, radiotherapy, surgery, immunotherapy and other anti-tumor therapy.
- Creatinine clearance < 30ml/min
- Has received epidermal growth factor targeting 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 |
|---|---|---|
| NimotuzumabAlso: RadiationDrug: Nimotuzumab Radiation: Intensity Modulated Radiation Therapy | Drug | Nimotuzumab plus IMRT |
Primary outcome
Tumor response rate after Nimotuzumab concurrent with radiotherapy for recurrent NPC patients
Time frame: Three month after patients subject to the treatment
The response status (Complete Response + Partial Response) was evaluated according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Complete response was defined as disappearance of all target lesions, and Partial response was defined as at least a 30% reduction in the sum of the longest diameter of target lesions, taking as reference the baseline study.
Toxicity of this combined treatment for recurrent NPC patients
Time frame: Three month after patients subject to the treatment
Adverse events of this combined modality treatment were graded according to CTCAE (Common Terminology Criteria for Adverse Events) v3.0 criteria.Toxicity Criteria for Adverse Events version 3.0
3 secondary outcomes
Local Progression free survival
Time frame: Three years
Disease-free survival
Time frame: Three years
Overall survival
Time frame: Three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nimotuzumab in people with Recurrent Nasopharyngeal Carcinoma, run by Fujian Cancer Hospital 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 10 inclusion and 15 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 11 Sep 2018. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SHAOJUN LIN, Dr. (0591-62752225, linshaojun@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response rate after Nimotuzumab concurrent with radiotherapy for recurrent NPC patients (time frame: Three month after patients subject to the treatment). 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 11 Sep 2018.