- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04012502
De-escalation Protocols in HPV-related Oropharyngeal Carcinoma in Chinese Populations
July 8, 2019 updated by: Chaosu Hu, Fudan University
De-escalation of Chemoradiotherapy Density in HPV-related Oropharyngeal Carcinoma in Chinese Populations
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
83
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tingting Xu, MD
- Phone Number: +8618017312903
- Email: dr_tingtingxu@163.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Recruiting
- Fudan Universtiy Shanghai Cancer Centre
-
Contact:
- Tingting Xu, MD
- Phone Number: +8618017312903
- Email: dr_tingtingxu@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: NONE
Arms and Interventions
Participant Group / 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)
|
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)
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS
Time Frame: 2 year
|
Progression Free Survival
|
2 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OS
Time Frame: 2 year
|
Overall Survival
|
2 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 1, 2019
Primary Completion (ACTUAL)
July 1, 2019
Study Completion (ANTICIPATED)
December 31, 2020
Study Registration Dates
First Submitted
July 4, 2019
First Submitted That Met QC Criteria
July 8, 2019
First Posted (ACTUAL)
July 9, 2019
Study Record Updates
Last Update Posted (ACTUAL)
July 9, 2019
Last Update Submitted That Met QC Criteria
July 8, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-OR001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingStage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7 | Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Pathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma... and other conditionsUnited States
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-
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-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI); National Institute of Dental and Craniofacial...Active, not recruitingStage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7 | Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7 | Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7United States
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