Back to resultsDe-escalation Protocols in HPV-related Oropharyngeal Carcinoma in Chinese Populations
Primary Purpose
Oropharyngeal Carcinoma, De-escalation
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Toxicities reduced treatment
conventional treatment
Sponsored by
About this trial
This is an interventional treatment trial for Oropharyngeal Carcinoma
Eligibility 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)
Sites / Locations
- Fudan Universtiy Shanghai Cancer CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
conventional treatment arm
Toxicities reduced treatment arm
Arm Description
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)
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)
Outcomes
Primary Outcome Measures
PFS
Progression Free Survival
Secondary Outcome Measures
OS
Overall Survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04012502
Brief Title
De-escalation Protocols in HPV-related Oropharyngeal Carcinoma in Chinese Populations
Official Title
De-escalation of Chemoradiotherapy Density in HPV-related Oropharyngeal Carcinoma in Chinese Populations
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharyngeal Carcinoma, De-escalation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
83 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
conventional treatment arm
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Toxicities reduced treatment arm
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Toxicities reduced treatment
Intervention Description
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 Type
Other
Intervention Name(s)
conventional treatment
Intervention Description
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)
Primary Outcome Measure Information:
Title
PFS
Description
Progression Free Survival
Time Frame
2 year
Secondary Outcome Measure Information:
Title
OS
Description
Overall Survival
Time Frame
2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tingting xu, MD
Phone
+8618017312903
Email
dr_tingtingxu@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
xueguan Lu, MD
Phone
+8618121299382
Email
luxueguan@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chaosu Hu, MD
Organizational Affiliation
Fudan University Shanghai cancer centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan Universtiy Shanghai Cancer Centre
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tingting Xu, MD
Phone
+8618017312903
Email
dr_tingtingxu@163.com
First Name & Middle Initial & Last Name & Degree
Xueguan Lu, MD
Phone
+8618121299382
Email
luxueguan@163.com
12. IPD Sharing Statement
Learn more about this trial
De-escalation Protocols in HPV-related Oropharyngeal Carcinoma in Chinese Populations
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