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出境医 / 临床实验 / New Strategy of Improving Treatment Outcome and Larynx-preservation Rate in Locally Advanced Hypopharyngeal Carcinoma

New Strategy of Improving Treatment Outcome and Larynx-preservation Rate in Locally Advanced Hypopharyngeal Carcinoma

Study Description
Brief Summary:
To develope stratification treatment for the patients who have locally advanced hypopharyngeal carcinoma. Experimental group patients were treated individually according to the response status after induction chemotherapy, receiving chemoradiotherapy or surgery. Thus to achieve a better survival rate and a higher larynx-preservation rate as well as a lower treatment related toxicity rate compared with standard treatment.

Condition or disease Intervention/treatment Phase
Hypopharyngeal Cancer Drug: Induction CT+ CRT group Radiation: Concurrent CRT group Phase 2

Detailed Description:
Eligiblity patient were assign to induction chemotherapy plus concurrent chemotherapy group (IC +CCRT group, Arm A)and concurrent chemoradiotherapy group(CCRT group, Arm B). For patients in Arm A, treatment response were evaluated after 2cycles, if the response reached partial response/complete response, patients received concurrent chemoradiotherapy, otherwise, patients will received surgery and radiotherpay/concurrent chemoradiotherapy after surgery. For patients received concurrent chemoradiotherapy (both in Arm A and Arm B) , treatment response were evaluated at 50 Gy. if response reached complete response or major partial response(>80% tumor regression), patients will received radical chemoradiotherapy, otherwise, patients will received surgery.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: New Strategy of Improving Treatment Outcome and Larynx-preservation Rate in Locally Advanced Hypopharyngeal Carcinoma
Study Start Date : September 2014
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : March 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Induction chemotherapy and concurret chemoradiotherapy group
Patients receive 2 cycles of paclitaxel, cisplatin and 5-Fluorouracil chemotherapy followed by Surgery or Chemo-radiotherapy according to the response status after induction chemo.
 Drug: Induction CT+ CRT group
Induction CT: Paclitaxel 175mg/m2 IV on d1 and d22, cisplatin 75mg/m2 IV on d1 and d22, 5-Fluorouracil 750mg/m2 IV continuously on d1-4 and d22-25, CRT: cisplatin 80mg/m2 IV on d1 of each 21 days cycle and 70 Gy radiotherapy
Active Comparator: Concurrent chemoradiotherapy group
Patients receive single-agent cisplatin chemotherapy concurrent with Radiotherapy
 Radiation: Concurrent CRT group
cisplatin 100mg/m2 IV on d1 of each 21 days cycle and 70 Gy radiotherapy
Outcome Measures
Primary Outcome Measures :
  1. overall survival [ Time Frame: 5 year ]

Secondary Outcome Measures :
  1. disease free survival [ Time Frame: 5 year ]
  2. distant-metastasis free survival [ Time Frame: 5 year ]
  3. larynx-preservation rate [ Time Frame: 5 year ]
  4. treatment related toxicities [ Time Frame: 2 year ]
    hematology and surgery related complications


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven squamous cell carcinoma of hypopharynx
  • Stage III/IV M0, with T3/4 N0-3 or T1-4 N2-3
  • Karnofsky Performance Status>=70
  • Have measurable lesions on CT/MRI
  • Treatment for the first time
  • Expected lifetime > 6 months
  • Normal blood test, hepatic and renal functions
  • Normal hearing
  • Can understand and sign the consent
  • Have follow up condition

Exclusion Criteria:

  • Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ)
  • Previously treatment for cancer
  • Pregnant or breeding woman, female without contraception
  • Enrolling in other drug trials
  • Severe comorbidities including myocardial infarction, arrhythmia, cerebral vascular disease, ulceration disease, mental disease and uncontrolled diabetes
  • Without follow up
  • Receive target therapy
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Junlin Yi, Professor 0086013661217998 yijunlin1969@163.com

Locations
Layout table for location information
China
Cancer hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, China, 100021
Contact: Junlin YI, MD    861087788504    junlinyi@sohu.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
Layout table for investigator information
Principal Investigator: Junlin Yi, Professor CAMS
Tracking Information
First Submitted Date  ICMJE June 5, 2018
First Posted Date  ICMJE June 15, 2018
Last Update Posted Date January 29, 2021
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2018) 		overall survival [ Time Frame: 5 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2018)
  • disease free survival [ Time Frame: 5 year ]
  • distant-metastasis free survival [ Time Frame: 5 year ]
  • larynx-preservation rate [ Time Frame: 5 year ]
  • treatment related toxicities [ Time Frame: 2 year ]
    hematology and surgery related complications
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 New Strategy of Improving Treatment Outcome and Larynx-preservation Rate in Locally Advanced Hypopharyngeal Carcinoma
Official Title  ICMJE New Strategy of Improving Treatment Outcome and Larynx-preservation Rate in Locally Advanced Hypopharyngeal Carcinoma
Brief Summary To develope stratification treatment for the patients who have locally advanced hypopharyngeal carcinoma. Experimental group patients were treated individually according to the response status after induction chemotherapy, receiving chemoradiotherapy or surgery. Thus to achieve a better survival rate and a higher larynx-preservation rate as well as a lower treatment related toxicity rate compared with standard treatment.
Detailed Description Eligiblity patient were assign to induction chemotherapy plus concurrent chemotherapy group (IC +CCRT group, Arm A)and concurrent chemoradiotherapy group(CCRT group, Arm B). For patients in Arm A, treatment response were evaluated after 2cycles, if the response reached partial response/complete response, patients received concurrent chemoradiotherapy, otherwise, patients will received surgery and radiotherpay/concurrent chemoradiotherapy after surgery. For patients received concurrent chemoradiotherapy (both in Arm A and Arm B) , treatment response were evaluated at 50 Gy. if response reached complete response or major partial response(>80% tumor regression), patients will received radical chemoradiotherapy, otherwise, patients will received surgery.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypopharyngeal Cancer
Intervention  ICMJE
  • Drug: Induction CT+ CRT group
    Induction CT: Paclitaxel 175mg/m2 IV on d1 and d22, cisplatin 75mg/m2 IV on d1 and d22, 5-Fluorouracil 750mg/m2 IV continuously on d1-4 and d22-25, CRT: cisplatin 80mg/m2 IV on d1 of each 21 days cycle and 70 Gy radiotherapy
  • Radiation: Concurrent CRT group
    cisplatin 100mg/m2 IV on d1 of each 21 days cycle and 70 Gy radiotherapy
Study Arms  ICMJE
  • Experimental: Induction chemotherapy and concurret chemoradiotherapy group
    Patients receive 2 cycles of paclitaxel, cisplatin and 5-Fluorouracil chemotherapy followed by Surgery or Chemo-radiotherapy according to the response status after induction chemo.
    Intervention: Drug: Induction CT+ CRT group
  • Active Comparator: Concurrent chemoradiotherapy group
    Patients receive single-agent cisplatin chemotherapy concurrent with Radiotherapy
    Intervention: Radiation: Concurrent CRT group
Publications *
  • Blanchard P, Baujat B, Holostenco V, Bourredjem A, Baey C, Bourhis J, Pignon JP; MACH-CH Collaborative group. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): a comprehensive analysis by tumour site. Radiother Oncol. 2011 Jul;100(1):33-40. doi: 10.1016/j.radonc.2011.05.036. Epub 2011 Jun 16.
  • Blanchard P, Bourhis J, Lacas B, Posner MR, Vermorken JB, Cruz Hernandez JJ, Bourredjem A, Calais G, Paccagnella A, Hitt R, Pignon JP; Meta-Analysis of Chemotherapy in Head and Neck Cancer, Induction Project, Collaborative Group. Taxane-cisplatin-fluorouracil as induction chemotherapy in locally advanced head and neck cancers: an individual patient data meta-analysis of the meta-analysis of chemotherapy in head and neck cancer group. J Clin Oncol. 2013 Aug 10;31(23):2854-60. doi: 10.1200/JCO.2012.47.7802. Epub 2013 Jul 8.
  • Pointreau Y, Garaud P, Chapet S, Sire C, Tuchais C, Tortochaux J, Faivre S, Guerrif S, Alfonsi M, Calais G. Randomized trial of induction chemotherapy with cisplatin and 5-fluorouracil with or without docetaxel for larynx preservation. J Natl Cancer Inst. 2009 Apr 1;101(7):498-506. doi: 10.1093/jnci/djp007. Epub 2009 Mar 24.

*   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: June 5, 2018) 		96
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically proven squamous cell carcinoma of hypopharynx
  • Stage III/IV M0, with T3/4 N0-3 or T1-4 N2-3
  • Karnofsky Performance Status>=70
  • Have measurable lesions on CT/MRI
  • Treatment for the first time
  • Expected lifetime > 6 months
  • Normal blood test, hepatic and renal functions
  • Normal hearing
  • Can understand and sign the consent
  • Have follow up condition

Exclusion Criteria:

  • Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ)
  • Previously treatment for cancer
  • Pregnant or breeding woman, female without contraception
  • Enrolling in other drug trials
  • Severe comorbidities including myocardial infarction, arrhythmia, cerebral vascular disease, ulceration disease, mental disease and uncontrolled diabetes
  • Without follow up
  • Receive target therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Junlin Yi, Professor 0086013661217998 yijunlin1969@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03558035
Other Study ID Numbers  ICMJE LC2014L12
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 Not Provided
Responsible Party Jun-Lin Yi, MD, Chinese Academy of Medical Sciences
Study Sponsor  ICMJE Chinese Academy of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Junlin Yi, Professor CAMS
PRS Account Chinese Academy of Medical Sciences
Verification Date January 2021

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

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