Nasopharyngeal CarcinomaNCT04764149
Platinum Plus Low-dose Long-term Continuous Intravenous Infused 5-Fluorouracil in Recurrent Nasopharyngeal Carcinoma
An observational study of Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
Local control rates of nasopharyngeal carcinoma are increasing, but 15% of patients still have local recurrence within 5 years after initial treatment. Systematic treatment based on chemotherapy has become the mainstream approach for recurrent nasopharyngeal carcinoma which is intolerant to local therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- Type of treatment
- Injection or infusion
- How many people
- 801 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2019to 30 Jun 2022
- Phase
- Observational
- 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
Study population: patients involved in our study were patients who had histologically or cytologically confirmed NPC with diagnosed recurrent NPC during 2006-2018 and receiving treatment in our hospital.
Who may be able to join
- patients involved in our study were patients who had histologically or cytologically confirmed NPC with diagnosed recurrent NPC during 2006-2018 and receiving treatment in our hospital.
Who cannot join
- Age <18 or >70 years old
- Pathologic type unknown or except type I-III of World Health Organization classification
- Never underwent platinum-based chemotherapy
- Lack of information about T classification and N classification when metastasis
- Lost follow-up within one month from the start of treatment for metastasis
- With other malignances
Trial locations and contacts
1 site in 1 country.
Ying-hong Wei, MD contact
China1 site, 1 recruiting
- Recruiting
Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060
Yun-fei Xia, MD, +8613602805461, xiayf@sysucc.org.cn
Ying-hong Wei, MD, +8619868588050, weiyh@sysucc.org.cn
About this study
Official title: Efficacy and Safety of Platinum Plus Continuous Intravenous Infused 5-Fluorouracil With Low Dose and Long Term Versus Other Platinum-Based Chemotherapy in Recurrent Nasopharyngeal Carcinoma: A Case-Cohort Study
Local control rates of nasopharyngeal carcinoma are increasing, but 15% of patients still have local recurrence within 5 years after initial treatment. Systematic treatment based on chemotherapy has become the mainstream approach for recurrent nasopharyngeal carcinoma which is intolerant to local therapy. we sought to find an efficient chemotherapy regimen with high tolerance according to the characteristics of chemotherapy drugs, that is, to explore the efficacy and safety of platinum plus 5-fluorouracil with continuous intravenous infusion at a low dose for a long term.
Read the detailed description
Nasopharyngeal carcinoma (NPC) is a malignant tumor of the nasopharyngeal epithelium with high sensitivity to ionizing radiation, but failure in local control was observed in approximately 15% of patients.
Chemotherapy is the cornerstone of the treatment of recurrent NPC. Many studies were aimed at the systemic treatment of recurrent NPC, but most of them were retrospective studies or phase II trials with small samples. Platinum-containing doublet chemotherapy is generally regarded as the standard treatment for recurrent NPC. After a multicenter phase III randomized clinical trial was published in 2016, gemcitabine plus cisplatin is recommended, however, less than 60% of patients could complete the treatment in the trail. Finding a proper regimen with promising efficacy results as well as high tolerance is still a big challenge.
Cisplatin plus 5-fluorouracil (PF) is a classical regimen widely used in recurrent NPC. The continuous infusion of 5-fluorouracil with low dose was investigated in esophagus carcinoma, rectal carcinoma and prostate carcinoma with encouraging outcome and acceptable toxicity. Whereas, data of platinum containing chemotherapy with low-dose continuous infused 5-fluorouracil in recurrent NPC was absent. In this study, we aimed to investigate the antitumor activity of platinum plus low-dose long-term continuous intravenous infused 5-fluorouracil (PFLL).
- Conditions
- Nasopharyngeal Carcinoma
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PFll Group | Patients were treated with PFLL regimen: 5-fluorouracil intravenous infusion at 200mg/m2/d for 30 continuous days and intravenous infusion of platinum (cisplatin 70 mg/m2 or nedaplatin 80/m2 or lobaplatin 30 mg/ m2) on day 1 and day 28, every 60 days. Local treatment, molecular-targeted or immune checkpoint therapy, and supportive treatment were allowed. | |
| Non-PFLL Group | Patients were treated with other platinum-based chemotherapy every 21 days including: PF regimen: 5-fluorouracil at a dose of 1,000 mg/m2 daily by continuous intravenous infusion on days 1-4 and intravenous infusion of cisplatin at a dose of 80 mg/m2 on day 1. GP regimen: gemcitabine at a dose of 1,000 mg/m2 by intravenous infusion on days 1, 8, and intravenous infusion of cisplatin at a dose of 80 mg/m2 on day 1. TP regimen: paclitaxel intravenous infusion at a dose of 175 mg/m2 or docetaxel at a dose of 75 mg/m2 on day 1 and intravenous infusion of cisplatin at a dose of 75 mg/m2 on day 1. TPF regimen: paclitaxel intravenous infusion at a dose of 175 mg/m2 or docetaxel at a dose of 75 mg/m2 on day 1; cisplatin intravenous infusion at a dose of 75 mg/m2 on day 1 and continuous intravenous infusion of 5-FU at a dose of 750 mg/m2 daily on days 1-5. Local treatment, molecular-targeted or immune checkpoint therapy, and supportive treatment were allowed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year overall survival
The period until death is detected.
Measured: 5 years after diagnosis of recurrent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Nov 2019
- Primary completion30 Jan 2022 (estimated)
- Study completion30 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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 801 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yun-fei Xia, Sun Yat-sen University
- Investigators
- Yun-fei Xia, MD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764149
- Sponsor's protocol ID
- 2020-FXY-429
- Status last verified
- Feb 2021
- First submitted
- 18 Feb 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Platinum Plus Continuous Intravenous Infused 5-Fluorouracil With Low Dose and Long Term Versus Other Platinum-Based Chemotherapy in Recurrent Nasopharyngeal Carcinoma: A Case-Cohort Study
- ClinicalTrials.gov ID
- NCT04764149
- Acronym / sponsor ID
- 2020-FXY-429
- Conditions
- Nasopharyngeal Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 801 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Jan 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 21 Feb 2021 (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.
Local control rates of nasopharyngeal carcinoma are increasing, but 15% of patients still have local recurrence within 5 years after initial treatment. Systematic treatment based on chemotherapy has become the mainstream approach for recurrent nasopharyngeal carcinoma which is intolerant to local therapy. we sought to find an efficient chemotherapy regimen with high tolerance according to the characteristics of chemotherapy drugs, that is, to explore the efficacy and safety of platinum plus 5-fluorouracil with continuous intravenous infusion at a low dose for a long term.
Detailed description
Nasopharyngeal carcinoma (NPC) is a malignant tumor of the nasopharyngeal epithelium with high sensitivity to ionizing radiation, but failure in local control was observed in approximately 15% of patients.
Chemotherapy is the cornerstone of the treatment of recurrent NPC. Many studies were aimed at the systemic treatment of recurrent NPC, but most of them were retrospective studies or phase II trials with small samples. Platinum-containing doublet chemotherapy is generally regarded as the standard treatment for recurrent NPC. After a multicenter phase III randomized clinical trial was published in 2016, gemcitabine plus cisplatin is recommended, however, less than 60% of patients could complete the treatment in the trail. Finding a proper regimen with promising efficacy results as well as high tolerance is still a big challenge.
Cisplatin plus 5-fluorouracil (PF) is a classical regimen widely used in recurrent NPC. The continuous infusion of 5-fluorouracil with low dose was investigated in esophagus carcinoma, rectal carcinoma and prostate carcinoma with encouraging outcome and acceptable toxicity. Whereas, data of platinum containing chemotherapy with low-dose continuous infused 5-fluorouracil in recurrent NPC was absent. In this study, we aimed to investigate the antitumor activity of platinum plus low-dose long-term continuous intravenous infused 5-fluorouracil (PFLL).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PFll Group | – | –Patients were treated with PFLL regimen: 5-fluorouracil intravenous infusion at 200mg/m2/d for 30 continuous days and intravenous infusion of platinum (cisplatin 70 mg/m2 or nedaplatin 80/m2 or lobaplatin 30 mg/ m2) on day 1 and day 28, every 60 days. Local treatment, molecular-targeted or immune checkpoint therapy, and supportive treatment were allowed. |
| Non-PFLL Group | – | –Patients were treated with other platinum-based chemotherapy every 21 days including: PF regimen: 5-fluorouracil at a dose of 1,000 mg/m2 daily by continuous intravenous infusion on days 1-4 and intravenous infusion of cisplatin at a dose of 80 mg/m2 on day 1. GP regimen: gemcitabine at a dose of 1,000 mg/m2 by intravenous infusion on days 1, 8, and intravenous infusion of cisplatin at a dose of 80 mg/m2 on day 1. TP regimen: paclitaxel intravenous infusion at a dose of 175 mg/m2 or docetaxel at a dose of 75 mg/m2 on day 1 and intravenous infusion of cisplatin at a dose of 75 mg/m2 on day 1. TPF regimen: paclitaxel intravenous infusion at a dose of 175 mg/m2 or docetaxel at a dose of 75 mg/m2 on day 1; cisplatin intravenous infusion at a dose of 75 mg/m2 on day 1 and continuous intravenous infusion of 5-FU at a dose of 750 mg/m2 daily on days 1-5. Local treatment, molecular-targeted or immune checkpoint therapy, and supportive treatment were allowed. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients involved in our study were patients who had histologically or cytologically confirmed NPC with diagnosed recurrent NPC during 2006-2018 and receiving treatment in our hospital.
Key inclusion criteria (1 listed)
- patients involved in our study were patients who had histologically or cytologically confirmed NPC with diagnosed recurrent NPC during 2006-2018 and receiving treatment in our hospital.
Key exclusion criteria (6 listed)
- Age <18 or >70 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
5-year overall survival
Time frame: 5 years after diagnosis of recurrent
The period until death is detected.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
Ying-hong Wei, MD contact
Yun-fei Xia, MD 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?
An observational study of Nasopharyngeal Carcinoma, 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 1 inclusion and 6 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 21 Feb 2021. 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.
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 Yun-fei Xia, MD (+8613602805461, xiayf@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year overall survival (time frame: 5 years after diagnosis of recurrent). 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 21 Feb 2021.