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出境医 / 临床实验 / Induction Chemotherapy With Nab-paclitaxel, Cisplatin and Fluorouracil for Locoregionally Advanced Nasopharyngeal Carcinoma

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

Study Description
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

Study Design
Layout table for study information
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
Arms and Interventions
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
Outcome Measures
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


Eligibility Criteria
Layout table for eligibility information
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.
Contacts and Locations

Contacts
Layout table for location contacts
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 Workers Hospital
Wuzhou Red Cross Hospital
Tracking Information
First Submitted Date  ICMJE June 26, 2019
First Posted Date  ICMJE July 2, 2019
Last Update Posted Date July 5, 2019
Estimated Study Start Date  ICMJE July 5, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2019) 		Objective response rate (ORR) [ Time Frame: 3 years ]
To be determined by measurement of target lesions according to RECIST criteria
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
  • 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
  • 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
  • Adverse Events [ Time Frame: 3 years ]
    Incidence of Treatment-Emergent Adverse Events Evaluated according to NCI-CTC AE V4.03
Original Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2019)
  • 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
  • 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
  • Toxic effects [ Time Frame: 3 years ]
    Evaluated according to NCI-CTC AE V4.03.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Induction Chemotherapy With Nab-paclitaxel, Cisplatin and Fluorouracil for Locoregionally Advanced Nasopharyngeal Carcinoma
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Nasopharyngeal Carcinoma
  • Nasopharyngeal Cancer
  • Nasopharynx Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Drug: Nab-paclitaxel, Cisplatin and Fluorouracil
  • Radiation: concurrent chemoradiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 29, 2019) 		60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kai Hu +8613907710887 gxhukai@hotmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04004871
Other Study ID Numbers  ICMJE GuangxiMUHK1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kai Hu, Guangxi Medical University
Study Sponsor  ICMJE Guangxi Medical University
Collaborators  ICMJE
  • Second affiliated hospital of Guangxi Medical University
  • Guilin Medical University, China
  • Liuzhou Workers Hospital
  • Wuzhou Red Cross Hospital
Investigators  ICMJE Not Provided
PRS Account Guangxi Medical University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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