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Induction Chemotherapy With Nab-paclitaxel, Cisplatin and Fluorouracil for Locoregionally Advanced Nasopharyngeal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04004871
Recruitment Status : Not yet recruiting
First Posted : July 2, 2019
Last Update Posted : July 5, 2019
Sponsor:
Collaborators:
Second affiliated hospital of Guangxi Medical University
Guilin Medical University, China
Liuzhou Worker's Hospital
Wuzhou Red Cross Hospital
Information provided by (Responsible Party):
Kai Hu, Guangxi Medical University

Brief Summary:
Nasopharyngeal carcinoma (NPC) is commonly observed in southern China, particularly in the Pearl River delta area and the Xijiang River basin in the Guangdong and Guangxi provinces, with an incidence rate as high as 25‑50 per 100,000. The National Comprehensive Cancer Network guidelines (version 1, 2018), have recommended use of induction chemotherapy followed by CCRT as category 2A for NPC, especially the TPF regimen as category 1 for EBV-associated disease. The nanoparticle albumin-bound paclitaxel (Nab-paclitaxel) is a promising new agent with more efficient entry to the tumor microenvironment and preferential uptake by cancer cells. Superior activity of Nab-paclitaxel regimens without the necessity for antianaphylactic pretreatments has been shown in various solid tumors compared with the traditional solvent-based paclitaxel-based ones. However, the safety and efficacy of combination of Nab-paclitaxel, cisplatin and Fluorouracil (APF) has not been determined in patients with locoregionally advanced NPC. In this prospective, Multi-centeric, Open, Non-controlled phase II clinical trial, investigators perform an exploratory study to the efficacy and Safety of APF.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Nasopharyngeal Cancer Nasopharynx Cancer Drug: Nab-paclitaxel, Cisplatin and Fluorouracil Radiation: concurrent chemoradiotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Induction Chemotherapy With Nab-paclitaxel, Cisplatin and Fluorouracil, Concurrent Chemotherapy of Cisplatin and IMRT in Locoregionally Advanced Nasopharyngeal Carcinoma: A Prospective, Multi-centeric, Open, Non-controlled, Phase II Clinical Trial
Estimated Study Start Date : July 5, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Induction chemotherapy and concurrent chemoradiotherapy
Patients receive induction chemotherapy with Nab-paclitaxel, cisplatin and fluorouracil every three weeks for three cycles before radiotherapy, and then receive concurrent chemoradiotherapy.
Drug: Nab-paclitaxel, Cisplatin and Fluorouracil
Patients receive Nab-paclitaxel (200mg/m2 on day 1), cisplatin (60mg/m2 on day 1) and fluorouracil (600mg/m2 on Days 1 to 5) every three weeks for three cycles before concurrent chemoradiotherapy.
Other Name: APF induction chemotherapy

Radiation: concurrent chemoradiotherapy
Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.
Other Name: Radical radiotherapy and concurrent cisplatin




Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: 3 years ]
    To be determined by measurement of target lesions according to RECIST criteria


Secondary Outcome Measures :
  1. Failure-free survival (FFS) [ Time Frame: 3 years ]
    From the date of registration to the date of either locally, regionally or distant failure or last follow-up

  2. Overall survival(OS) [ Time Frame: 3 years ]
    From the date of registration to the date of death is observed or to last follow-up visit

  3. Adverse Events [ Time Frame: 3 years ]
    Incidence of Treatment-Emergent Adverse Events Evaluated according to NCI-CTC AE V4.03



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).
  2. Tumor staged as T3-4/N1-3 (according to the 8th UICC edition).
  3. No evidence of distant metastasis (M0).
  4. EBV positive.
  5. Satisfactory performance status: ECOG≤2.
  6. Adequate marrow: leucocyte count ≥4000/uL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
  7. 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 ≤ULN.
  8. Adequate renal function: creatinine clearance ≥60 ml/min.
  9. Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

  1. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
  2. Age>60 years or <18 years.
  3. Treatment with palliative intent.
  4. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
  5. Pregnancy or lactation.
  6. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
  7. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
  8. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04004871


Contacts
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Contact: Kai Hu +8613907710887 gxhukai@hotmail.com

Sponsors and Collaborators
Guangxi Medical University
Second affiliated hospital of Guangxi Medical University
Guilin Medical University, China
Liuzhou Worker's Hospital
Wuzhou Red Cross Hospital
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Responsible Party: Kai Hu, Clinical Professor, Guangxi Medical University
ClinicalTrials.gov Identifier: NCT04004871    
Other Study ID Numbers: GuangxiMUHK1
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Paclitaxel
Cisplatin
Fluorouracil
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs