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出境医 / 临床实验 / Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in Patients With LA-NPC

Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in Patients With LA-NPC

Study Description
Brief 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. 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.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: Nab-paclitaxel Phase 2

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Induction Chemotherapy With Nab-paclitaxel and Nedaplatin Followed by Concurrent Chemoradiotherapy in Patients With Locally Advanced Nasopharyngeal Carcinoma
Estimated Study Start Date : July 9, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : June 1, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Nab-paclitaxel+Nedaplatin
induction chemotherapy by nab-paclitaxel and nedaplatin followed by concurrent chemoradiotherapy
 Drug: Nab-paclitaxel
induction chemotherapy with nab-paclitaxel and nedaplatin followed by concurrent chemoradiotherapy
Other Name: Paclitaxel for Injection (Albumin Bound)
Active Comparator: Paclitaxel+Nedaplatin
induction chemotherapy by paclitaxel and nedaplatin followed by concurrent chemoradiotherapy
 Drug: Nab-paclitaxel
induction chemotherapy with nab-paclitaxel and nedaplatin followed by concurrent chemoradiotherapy
Other Name: Paclitaxel for Injection (Albumin Bound)
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. Progression-Free Survival(PFS) [ Time Frame: 3 years ]
    From the date of enrollment 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 enrollment to the date of death is observed or to last follow-up visit


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age, 18-75 years old.
  2. Patients with newly histologically confirmed NPC.
  3. WHO Type Ⅱ and Ⅲ.
  4. Tumor staged as Ⅲ-ⅣA (according to the 8th AJCC edition).
  5. No serious organ dysfunction of heart, lung, liver, kidney.
  6. No distant metastasis.
  7. Hematological examinations:WBC≥3.5×109/L, NEUT#≥1.5×109/L, PLT≥90×109/L, HB≥90g/L.
  8. 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.
  9. Patients must be given written informed consent.

Exclusion Criteria:

  1. age >75 years or <18years.
  2. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
  3. History of previous radiotherapy and chemotherapy.
  4. Known or suspected to be allergic to platinum and Nab-paclitaxel.
  5. Pregnancy or lactation.
  6. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial.
  7. Peripheral sensory neuropathy> grade 1.
  8. Uncontrolled heart clinical symptoms or diseases.
Contacts and Locations

Contacts
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Contact: wenmin ying, bachelor 228 59125 18352770@qq.com
Contact: xiaoyan li 228 59125

Locations
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China, Fujian
No. 156, North Road, Xierhuan Road Recruiting
Fuzhou, Fujian, China
Contact: wenmin ying, bachelor    15080015210      
Sponsors and Collaborators
Fuzhou General Hospital
Investigators
Layout table for investigator information
Study Chair: zhichao fu, M.D Fuzhou General Hospital of Nanjing Military Regio，Department of Radiotherapy
Tracking Information
First Submitted Date  ICMJE July 9, 2019
First Posted Date  ICMJE July 11, 2019
Last Update Posted Date July 11, 2019
Estimated Study Start Date  ICMJE July 9, 2019
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 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 No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
  • Progression-Free Survival(PFS) [ Time Frame: 3 years ]
    From the date of enrollment 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 enrollment to the date of death is observed or to last follow-up visit
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in Patients With LA-NPC
Official Title  ICMJE Induction Chemotherapy With Nab-paclitaxel and Nedaplatin Followed by Concurrent Chemoradiotherapy in Patients With Locally Advanced Nasopharyngeal Carcinoma
Brief 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. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Nasopharyngeal Carcinoma
Intervention  ICMJE Drug: Nab-paclitaxel
induction chemotherapy with nab-paclitaxel and nedaplatin followed by concurrent chemoradiotherapy
Other Name: Paclitaxel for Injection (Albumin Bound)
Study Arms  ICMJE
  • Experimental: Nab-paclitaxel+Nedaplatin
    induction chemotherapy by nab-paclitaxel and nedaplatin followed by concurrent chemoradiotherapy
    Intervention: Drug: Nab-paclitaxel
  • Active Comparator: Paclitaxel+Nedaplatin
    induction chemotherapy by paclitaxel and nedaplatin followed by concurrent chemoradiotherapy
    Intervention: Drug: Nab-paclitaxel
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 9, 2019) 		92
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2022
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age, 18-75 years old.
  2. Patients with newly histologically confirmed NPC.
  3. WHO Type Ⅱ and Ⅲ.
  4. Tumor staged as Ⅲ-ⅣA (according to the 8th AJCC edition).
  5. No serious organ dysfunction of heart, lung, liver, kidney.
  6. No distant metastasis.
  7. Hematological examinations:WBC≥3.5×109/L, NEUT#≥1.5×109/L, PLT≥90×109/L, HB≥90g/L.
  8. 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.
  9. Patients must be given written informed consent.

Exclusion Criteria:

  1. age >75 years or <18years.
  2. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
  3. History of previous radiotherapy and chemotherapy.
  4. Known or suspected to be allergic to platinum and Nab-paclitaxel.
  5. Pregnancy or lactation.
  6. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial.
  7. Peripheral sensory neuropathy> grade 1.
  8. Uncontrolled heart clinical symptoms or diseases.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: wenmin ying, bachelor 228 59125 18352770@qq.com
Contact: xiaoyan li 228 59125
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04015661
Other Study ID Numbers  ICMJE 20190515
Has Data Monitoring Committee No
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
Plan to Share IPD: No
Responsible Party Fuzhou General Hospital
Study Sponsor  ICMJE Fuzhou General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: zhichao fu, M.D Fuzhou General Hospital of Nanjing Military Regio，Department of Radiotherapy
PRS Account Fuzhou General Hospital
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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