Nasopharyngeal CarcinomaPhase 2NCT04015661
Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in Patients With LA-NPC
A Phase 2 study testing Nab-paclitaxel in people with Nasopharyngeal Carcinoma, run by Fuzhou General Hospital at 1 site in China.
Trial summary
Nasopharyngeal carcinoma (NPC) is a malignant tumor that originates in nasopharyngeal epithelial cells. It is common in southern China and Southeast Asia, but the incidence rate is low in most parts of the world. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Nab-paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 9 Jul 2019to 1 Jun 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age, 18-75 years old.
- Patients with newly histologically confirmed NPC.
- WHO Type Ⅱ and Ⅲ.
- Tumor staged as Ⅲ-ⅣA (according to the 8th AJCC edition).
- No serious organ dysfunction of heart, lung, liver, kidney.
- No distant metastasis.
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- Hematological examinations:WBC≥3.5×109/L, NEUT#≥1.5×109/L, PLT≥90×109/L, HB≥90g/L.
- Normal liver function test：Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤1.5×ULN，creatinine clearance ≥60 ml/min.
- Patients must be given written informed consent.
Who cannot join
- age >75 years or <18years.
- Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
- History of previous radiotherapy and chemotherapy.
- Known or suspected to be allergic to platinum and Nab-paclitaxel.
- Pregnancy or lactation.
- Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial.
- Peripheral sensory neuropathy> grade 1.
- Uncontrolled heart clinical symptoms or diseases.
Trial locations and contacts
1 site in 1 country.
xiaoyan li contact
China1 site, 1 recruiting
- Recruiting
No. 156, North Road, Xierhuan Road
Fuzhou, Fujian
wenmin ying, bachelor, 15080015210
About this study
Official title: Induction Chemotherapy With Nab-paclitaxel and Nedaplatin Followed by Concurrent Chemoradiotherapy in Patients With Locally Advanced Nasopharyngeal Carcinoma
Nasopharyngeal carcinoma (NPC) is a malignant tumor that originates in nasopharyngeal epithelial cells. It is common in southern China and Southeast Asia, but the incidence rate is low in most parts of the world. According to the World Health Organization survey, 80% of nasopharyngeal carcinomas occur in China, with high incidence in southern China, as high as 30-50/100,000, such as Guangdong, Guangxi, Hunan, and Fujian. In 2015, Chinese cancer statistics showed that there were about 60,600 new cases of nasopharyngeal carcinoma in China, and the number of deaths was about 34,100. Radiation therapy is the main treatment for nasopharyngeal carcinoma. Early stage I and IIa achieved a 5-year survival rate (OS) of 90% and 84%, respectively . However, the treatment outcomes of most patients with locally advanced nasopharyngeal carcinoma are not ideal.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Nab-paclitaxel
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nab-paclitaxelDrug
Also called Paclitaxel for Injection (Albumin Bound)
induction chemotherapy with nab-paclitaxel and nedaplatin followed by concurrent chemoradiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Nab-paclitaxel+Nedaplatin | Experimental | induction chemotherapy by nab-paclitaxel and nedaplatin followed by concurrent chemoradiotherapy Receives: Drug: Nab-paclitaxel |
| Paclitaxel+Nedaplatin | Active comparator | induction chemotherapy by paclitaxel and nedaplatin followed by concurrent chemoradiotherapy Receives: Drug: Nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
To be determined by measurement of target lesions according to RECIST criteria
Measured: 3 years
Secondary outcomes (2)
Progression-Free Survival(PFS)
From the date of enrollment to the date of either locally, regionally or distant failure or last follow-up
Measured: 3 years
Overall survival（OS）
From the date of enrollment to the date of death is observed or to last follow-up visit
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 posted11 Jul 2019
- Study start9 Jul 2019 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Jun 2022 (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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fuzhou General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- zhichao fu, M.D, Study chair, Fuzhou General Hospital of Nanjing Military Regio，Department of Radiotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015661
- Sponsor's protocol ID
- 20190515
- Status last verified
- Jul 2019
- First submitted
- 9 Jul 2019
- Last updated
- 11 Jul 2019
- 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 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction Chemotherapy With Nab-paclitaxel and Nedaplatin Followed by Concurrent Chemoradiotherapy in Patients With Locally Advanced Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT04015661
- Acronym / sponsor ID
- 20190515
- Conditions
- Nasopharyngeal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Fuzhou General HospitalUniversity, hospital or other
- Study start
- 9 Jul 2019 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 11 Jul 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.
Nasopharyngeal carcinoma (NPC) is a malignant tumor that originates in nasopharyngeal epithelial cells. It is common in southern China and Southeast Asia, but the incidence rate is low in most parts of the world. According to the World Health Organization survey, 80% of nasopharyngeal carcinomas occur in China, with high incidence in southern China, as high as 30-50/100,000, such as Guangdong, Guangxi, Hunan, and Fujian. In 2015, Chinese cancer statistics showed that there were about 60,600 new cases of nasopharyngeal carcinoma in China, and the number of deaths was about 34,100. Radiation therapy is the main treatment for nasopharyngeal carcinoma. Early stage I and IIa achieved a 5-year survival rate (OS) of 90% and 84%, respectively . However, the treatment outcomes of most patients with locally advanced nasopharyngeal carcinoma are not ideal.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nab-paclitaxel+Nedaplatin | Experimental | Drug: Nab-paclitaxelinduction chemotherapy by nab-paclitaxel and nedaplatin followed by concurrent chemoradiotherapy |
| Paclitaxel+Nedaplatin | Active comparator | Drug: Nab-paclitaxelinduction chemotherapy by paclitaxel and nedaplatin followed by concurrent chemoradiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age, 18-75 years old.
- Patients with newly histologically confirmed NPC.
- WHO Type Ⅱ and Ⅲ.
- Tumor staged as Ⅲ-ⅣA (according to the 8th AJCC edition).
- No serious organ dysfunction of heart, lung, liver, kidney.
Key exclusion criteria (8 listed)
- age >75 years or <18years.
- Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
- History of previous radiotherapy and chemotherapy.
- Known or suspected to be allergic to platinum and Nab-paclitaxel.
- 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 |
|---|---|---|
| Nab-paclitaxelAlso: Paclitaxel for Injection (Albumin Bound)induction chemotherapy with nab-paclitaxel and nedaplatin followed by concurrent chemoradiotherapy | Drug | Nab-paclitaxel+Nedaplatin, Paclitaxel+Nedaplatin |
Primary outcome
Objective response rate (ORR)
Time frame: 3 years
To be determined by measurement of target lesions according to RECIST criteria
2 secondary outcomes
Progression-Free Survival(PFS)
Time frame: 3 years
Overall survival（OS）
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 11 Jul 2019.
- 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.
xiaoyan li contact
zhichao fu, M.D study chair
Fuzhou General Hospital of Nanjing Military Regio，Department of Radiotherapy
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 Nab-paclitaxel in people with Nasopharyngeal Carcinoma, run by Fuzhou General 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 9 inclusion and 8 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 Jul 2019. 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 wenmin ying, bachelor (228 59125, 18352770@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 3 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 11 Jul 2019.