Back to resultsPostoperative CCRT With Docetaxel vs Cisplatin in High Risk Oral Cavity Cancer
Primary Purpose
Oral Cavity Squamous Cell Carcinoma
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Docetaxel
Cisplatin
IMRT
Sponsored by
About this trial
This is an interventional treatment trial for Oral Cavity Squamous Cell Carcinoma focused on measuring oral cavity squamous cell carcinoma, concurrent chemotherapy, High-Risk
Eligibility Criteria
Inclusion Criteria:
1.Histologically confirmed squamous cell carcinoma of the head and neck.Site of tumor origin in the oral cavity, oropharynx, larynx, or hypopharynx (excluding nasopharynx, or sinuses) 2. Gross total resection, with pathology demonstrating one or more of the following risk factors:
- Histologic extracapsular nodal extension
- Histologic involvement of ≥ 2 regional lymph nodes
- Invasive cancer seen on microscopic evaluation of the resection margin, with no evidence of gross tumor residual 3. No evidence of distant metastases 4. No synchronous or concurrent head and neck primary tumors 5. Karnofsky score over 60 6. Adequate organ function including the following:
- Absolute neutrophil count (ANC) >= 1.5 * 10^9/l
- Platelets count >= 100 * 10^9/l
- Hemoglobin >= 10 g/dl
- AST and ALT <= 2.5 times institutional upper limit of normal (ULN)
- Total bilirubin <= 1.5 times institutional ULN
- Creatinine clearance >= 50 ml/min
- Serum creatine <= 1 times ULN 7.Signed written informed consent
Exclusion Criteria:
- 1. Evidence of distant metastasis 2. Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region 3. Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma 4. Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures 5.Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
Sites / Locations
- Shanghai ninth people's hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental
Control
Arm Description
Concurrent Chemoradiotherapy With Docetaxel and IMRT
Concurrent Chemoradiotherapy With Cisplatinum and IMRT
Outcomes
Primary Outcome Measures
Disease-free survival
Secondary Outcome Measures
Acute toxicity profiles, graded according to the NCI CTCAE version 5.0
Late toxicity profiles, graded according to the NCI CTCAE version 4.0
overall survival rate
Full Information
NCT ID
NCT02923258
First Posted
October 3, 2016
Last Updated
October 13, 2023
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Collaborators
Fudan University
1. Study Identification
Unique Protocol Identification Number
NCT02923258
Brief Title
Postoperative CCRT With Docetaxel vs Cisplatin in High Risk Oral Cavity Cancer
Official Title
Postoperative Radiation and Concurrent Chemotherapy With Weekly Docetaxel Versus Cisplatin in Patients With High-risk Oral Cavity Cancer: a Randomized Phase II Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 21, 2018 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
April 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Collaborators
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a randomized,controled, phase II, open label study of postoperative concurrent chemoradiotherapy with Docetaxel versus Cisplatin for high-risk squamous cell carcinoma of the oral cavity cancer.The primary purpose of this study is to evaluate the efficacy of concurrent chemoradiotherapy with docetaxel in OCC patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Cavity Squamous Cell Carcinoma
Keywords
oral cavity squamous cell carcinoma, concurrent chemotherapy, High-Risk
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
224 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Concurrent Chemoradiotherapy With Docetaxel and IMRT
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Concurrent Chemoradiotherapy With Cisplatinum and IMRT
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
20mg/m2/w
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
100mg/m2/q3w
Intervention Type
Radiation
Intervention Name(s)
IMRT
Intervention Description
a total dose of 60Gy in 30fractions over 6 weeks
Primary Outcome Measure Information:
Title
Disease-free survival
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Acute toxicity profiles, graded according to the NCI CTCAE version 5.0
Time Frame
up to 6-7 weeks
Title
Late toxicity profiles, graded according to the NCI CTCAE version 4.0
Time Frame
up to 2 years
Title
overall survival rate
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1.Histologically confirmed squamous cell carcinoma of the oral cavity 2. Gross total resection, with pathology demonstrating one or more of the following risk factors:
Histologic extracapsular nodal extension
Histologic involvement of ≥ 2 regional lymph nodes
Invasive cancer is seen on microscopic evaluation of the resection margin, with no evidence of gross tumor residual 3. No evidence of distant metastases 4. No synchronous or concurrent head and neck primary tumors 5. ECOG 0-1 6. Adequate organ function including the following:
Absolute neutrophil count (ANC) >= 1.5 * 10^9/l
Platelets count >= 100 * 10^9/l
Hemoglobin >= 10 g/dl
AST and ALT <= 2.5 times institutional upper limit of normal (ULN)
Total bilirubin <= 1.5 times institutional ULN
Creatinine clearance >= 50 ml/min
Serum creatine <= 1 times ULN 7.Signed written informed consent
Exclusion Criteria:
1. Evidence of distant metastasis 2. Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region 3. Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma 4. Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures 5.Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guopei Zhu
Organizational Affiliation
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai ninth people's hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Postoperative CCRT With Docetaxel vs Cisplatin in High Risk Oral Cavity Cancer
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