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出境医 / 临床实验 / De-escalation Protocols in HPV-related Oropharyngeal Carcinoma in Chinese Populations

De-escalation Protocols in HPV-related Oropharyngeal Carcinoma in Chinese Populations

Study Description
Brief Summary:
Human papillomavirus (HPV)-related oropharyngeal carcinoma are exquisitely radiosensitive. Several studies attempted to reduce the toxicities of treatments through reduced-dose radiation and showed promising results, but all data were collected from non-Chinese areas. Like nasopharyngeal carcinoma, oropharyngeal carcinoma may have different biological behavior and relationship with HPV infection. So the investigators studied whether toxicities reducing treatment with reduced radiation dose and omitted concurrent chemotherapy after good response to induction chemotherapy would maintain survival outcomes while improving tolerability for patients with HPV-positive oropharyngeal carcinoma.

Condition or disease Intervention/treatment Phase
Oropharyngeal Carcinoma De-escalation Other: Toxicities reduced treatment Other: conventional treatment Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 83 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: De-escalation of Chemoradiotherapy Density in HPV-related Oropharyngeal Carcinoma in Chinese Populations
Actual Study Start Date : July 1, 2019
Actual Primary Completion Date : July 1, 2019
Estimated Study Completion Date : December 31, 2020
Arms and Interventions
Arm Intervention/treatment
Active Comparator: conventional treatment arm
Two cycles docetaxel+cisplatin (TP) induction chemotherapy followed by concurrent cisplatin chemoradiotherapy with standard radiation dose (70Gy/35Fx) when responses to induction chemotherapy are less than 50% Partial Response(PR)
 Other: conventional treatment
Two cycles docetaxel+cisplatin (TP) induction chemotherapy followed by concurrent cisplatin chemoradiotherapy with standard radiation dose (70Gy/35Fx) when responses to induction chemotherapy are less than 50% Partial Response(PR)
Experimental: Toxicities reduced treatment arm
Two cycles docetaxel+cisplatin (TP) induction chemotherapy followed by reducing radiation dose(60Gy/30Fx) and omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR)
 Other: Toxicities reduced treatment
Two cycles docetaxel+cisplatin (TP) induction chemotherapy followed by reducing radiation dose(60Gy/30Fx) and omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR)
Outcome Measures
Primary Outcome Measures :
  1. PFS [ Time Frame: 2 year ]
    Progression Free Survival


Secondary Outcome Measures :
  1. OS [ Time Frame: 2 year ]
    Overall Survival


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

Inclusion Criteria:

  • Histological diagnosis of squamous cell carcinoma of oropharynx with IHC p16 positive or PCR HPV16 positive
  • T1-2/N1-3M0（except T1N1M0 and single LN<3cm）or T3-4N0-3M0 according to UICC/AJCC 8th staging system
  • Age ≥18
  • No prior anti-tumor treatment
  • Karnofsky Performance Score (KPS)≥70
  • Adequate blood supply
  • Informed consent obtained

Exclusion Criteria:

  • cannot take contrast-MRI imaging
  • Pregnant
  • Combined with other malignant tumor (except basal cell carcinoma of skin)
Contacts and Locations

Contacts
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Contact: Tingting xu, MD +8618017312903 dr_tingtingxu@163.com
Contact: xueguan Lu, MD +8618121299382 luxueguan@163.com

Locations
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China, Shanghai
Fudan Universtiy Shanghai Cancer Centre Recruiting
Shanghai, Shanghai, China, 200032
Contact: Tingting Xu, MD    +8618017312903    dr_tingtingxu@163.com   
Contact: Xueguan Lu, MD    +8618121299382    luxueguan@163.com   
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Chaosu Hu, MD Fudan University Shanghai cancer centre
Tracking Information
First Submitted Date  ICMJE July 4, 2019
First Posted Date  ICMJE July 9, 2019
Last Update Posted Date July 9, 2019
Actual Study Start Date  ICMJE July 1, 2019
Actual Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2019) 		PFS [ Time Frame: 2 year ]
Progression Free Survival
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019) 		OS [ Time Frame: 2 year ]
Overall Survival
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 De-escalation Protocols in HPV-related Oropharyngeal Carcinoma in Chinese Populations
Official Title  ICMJE De-escalation of Chemoradiotherapy Density in HPV-related Oropharyngeal Carcinoma in Chinese Populations
Brief Summary Human papillomavirus (HPV)-related oropharyngeal carcinoma are exquisitely radiosensitive. Several studies attempted to reduce the toxicities of treatments through reduced-dose radiation and showed promising results, but all data were collected from non-Chinese areas. Like nasopharyngeal carcinoma, oropharyngeal carcinoma may have different biological behavior and relationship with HPV infection. So the investigators studied whether toxicities reducing treatment with reduced radiation dose and omitted concurrent chemotherapy after good response to induction chemotherapy would maintain survival outcomes while improving tolerability for patients with HPV-positive oropharyngeal carcinoma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Oropharyngeal Carcinoma
  • De-escalation
Intervention  ICMJE
  • Other: Toxicities reduced treatment
    Two cycles docetaxel+cisplatin (TP) induction chemotherapy followed by reducing radiation dose(60Gy/30Fx) and omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR)
  • Other: conventional treatment
    Two cycles docetaxel+cisplatin (TP) induction chemotherapy followed by concurrent cisplatin chemoradiotherapy with standard radiation dose (70Gy/35Fx) when responses to induction chemotherapy are less than 50% Partial Response(PR)
Study Arms  ICMJE
  • Active Comparator: conventional treatment arm
    Two cycles docetaxel+cisplatin (TP) induction chemotherapy followed by concurrent cisplatin chemoradiotherapy with standard radiation dose (70Gy/35Fx) when responses to induction chemotherapy are less than 50% Partial Response(PR)
    Intervention: Other: conventional treatment
  • Experimental: Toxicities reduced treatment arm
    Two cycles docetaxel+cisplatin (TP) induction chemotherapy followed by reducing radiation dose(60Gy/30Fx) and omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR)
    Intervention: Other: Toxicities reduced treatment
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 8, 2019) 		83
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Actual Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histological diagnosis of squamous cell carcinoma of oropharynx with IHC p16 positive or PCR HPV16 positive
  • T1-2/N1-3M0（except T1N1M0 and single LN<3cm）or T3-4N0-3M0 according to UICC/AJCC 8th staging system
  • Age ≥18
  • No prior anti-tumor treatment
  • Karnofsky Performance Score (KPS)≥70
  • Adequate blood supply
  • Informed consent obtained

Exclusion Criteria:

  • cannot take contrast-MRI imaging
  • Pregnant
  • Combined with other malignant tumor (except basal cell carcinoma of skin)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tingting xu, MD +8618017312903 dr_tingtingxu@163.com
Contact: xueguan Lu, MD +8618121299382 luxueguan@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04012502
Other Study ID Numbers  ICMJE 2019-OR001
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 Chaosu Hu, Fudan University
Study Sponsor  ICMJE Fudan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chaosu Hu, MD Fudan University Shanghai cancer centre
PRS Account Fudan 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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