- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04472403
Platinum Plus Low-dose Long-term Continuous Intravenous Infused 5-Fluorouracil in Metastatic Nasopharyngeal Carcinoma
Efficacy and Safety of Platinum Plus Continuous Intravenous Infused 5-Fluorouracil With Low Dose and Long Term Versus Other Platinum-Based Chemotherapy in Metastatic Nasopharyngeal Carcinoma: A Case-Cohort Study
Study Overview
Status
Conditions
Detailed Description
Nasopharyngeal carcinoma (NPC) is a malignant tumor of the nasopharyngeal epithelium with high sensitivity to ionizing radiation. With the use of intensive chemoradiotherapy, excellent treatment outcomes can be achieved for local control, but disease failure was observed in approximately 20% of patients. Moreover, approximately 10% of newly diagnosed patients diagnosed with metastasis, resulting in about 30% of NPC patients will present with either synchronous or metachronous metastasis in total.
Chemotherapy is the cornerstone of the treatment of metastatic NPC. Many studies were aimed at the systemic treatment of metastatic NPC, but most of them were retrospective studies or phase II trials with small samples. The outcome of metastatic NPC is poor with a median OS of about 20 months. Platinum-containing doublet chemotherapy is generally regarded as the standard treatment for metastatic 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 metastatic 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 metastatic 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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Shuo-han Zheng, MD
- Phone Number: +8613826478924
- Email: zhengsh1@sysucc.org.cn
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Recruiting
- Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
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Principal Investigator:
- Yun-fei Xia, MD
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Contact:
- Shuo-han Zheng, MD
- Phone Number: +8613826478924
- Email: zhengsh1@sysucc.org.cn
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Sub-Investigator:
- Shuo-han Zheng, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Nasopharyngeal carcinoma diagnosed by pathology or cytology
- Distant metastasis confirmed by Radiographic assessments or pathology.
- Patients ever received systemic chemotherapy.
Exclusion Criteria:
- 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
- Without other malignances
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
5-year overall survival
Time Frame: 5 years after diagnosis of metastasis
|
The period until death is detected.
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5 years after diagnosis of metastasis
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5-year subsequent-line treatment-free survival
Time Frame: 5 years after the start of the first-line treatment
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The period until earliest of the start date of subsequent-line treatment or death is detected.
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5 years after the start of the first-line treatment
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5-year survival without symptoms and toxicity
Time Frame: 5 years after diagnosis of metastasis
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The period until any events (death or disease progression or ≥grade 3 chemotherapy-related haematological toxicity) is detected.
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5 years after diagnosis of metastasis
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Haematological toxicity
Time Frame: From the start of the first-line treatment, evaluation was performed every cycle during the treatment and then every 3-6 months after the completion of the treatment, up to the start of subsequent-line treatment or death or 5 years.
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The incidence of myelosuppression
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From the start of the first-line treatment, evaluation was performed every cycle during the treatment and then every 3-6 months after the completion of the treatment, up to the start of subsequent-line treatment or death or 5 years.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
Other Study ID Numbers
- B2019-201-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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