Back to resultsConcurrent Chemotherapy Based on Genetic Testing in Patients With High-Risk Salivary Gland Tumors
Primary Purpose
Salivary Gland Tumors, Head and Neck Cancer
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Docetaxel
Intensity-modulated radiotherapy
Pemetrexed
Cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Salivary Gland Tumors focused on measuring Salivary Gland Tumors, Head and Neck Cancer, concurrent chemotherapy, genetic testing
Eligibility Criteria
Inclusion Criteria:
- Pathologically proven diagnosis of a malignant salivary gland tumor of intermediate or high-grade
- Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (≤ 5mm) or microscopically positive surgical margin
- Surgical resection with curative intent within 8 weeks prior to registration, with no evidence of gross tumor residual
- No evidence of distant metastases
- No synchronous or concurrent head and neck primary tumors
- Karnofsky score over 60
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
- Signed written informed consent
Exclusion Criteria:
- Evidence of distant metastasis
- Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
- Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
- Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
- 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 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Docetaxel arm
Pemetrexed arm
Cisplatin arm
Arm Description
Concurrent chemotherapy with Docetaxel if genetic testing show that the patient should be sensitive to this drug.
Concurrent chemotherapy with Pemetrexed if genetic testing show that the patient should be sensitive to this drug.
Concurrent chemotherapy with Cisplatin if genetic testing show that the patient was nor sensitive to neither Pemetrexed nor Docetaxel
Outcomes
Primary Outcome Measures
Acute toxicity profiles, graded according to the NCI CTCAE version 3.0
Secondary Outcome Measures
Disease-free survival
from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years
Full Information
NCT ID
NCT02921984
First Posted
September 30, 2016
Last Updated
March 16, 2018
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
1. Study Identification
Unique Protocol Identification Number
NCT02921984
Brief Title
Concurrent Chemotherapy Based on Genetic Testing in Patients With High-Risk Salivary Gland Tumors
Official Title
Concurrent Chemotherapy Based on Genetic Testing in Patients With High-Risk Salivary Gland Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
September 2013 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
August 2017 (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
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The role of postoperative concurrent chemotherapy (CCT) has not been established for salivary gland tumors (SGTs). This prospective study was conducted to evaluate the feasibility and safety of customized CCT regimens based on the gene targets of SGTs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Salivary Gland Tumors, Head and Neck Cancer
Keywords
Salivary Gland Tumors, Head and Neck Cancer, concurrent chemotherapy, genetic testing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Docetaxel arm
Arm Type
Experimental
Arm Description
Concurrent chemotherapy with Docetaxel if genetic testing show that the patient should be sensitive to this drug.
Arm Title
Pemetrexed arm
Arm Type
Experimental
Arm Description
Concurrent chemotherapy with Pemetrexed if genetic testing show that the patient should be sensitive to this drug.
Arm Title
Cisplatin arm
Arm Type
Experimental
Arm Description
Concurrent chemotherapy with Cisplatin if genetic testing show that the patient was nor sensitive to neither Pemetrexed nor Docetaxel
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Docetaxel only: 80 mg/m2 on day one, every 21 days if
Intervention Type
Radiation
Intervention Name(s)
Intensity-modulated radiotherapy
Intervention Description
a total dose of 60-66Gy in 30-32 fractions over 6-7 weeks
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Pemetrexed only: 500 mg/m2 on day one, every 21 days
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin only: 70 mg/m2 on day one to day three, every 21 days
Primary Outcome Measure Information:
Title
Acute toxicity profiles, graded according to the NCI CTCAE version 3.0
Time Frame
up to 6 weeks
Secondary Outcome Measure Information:
Title
Disease-free survival
Description
from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pathologically proven diagnosis of a malignant salivary gland tumor of intermediate or high-grade
Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (≤ 5mm) or microscopically positive surgical margin
Surgical resection with curative intent within 8 weeks prior to registration, with no evidence of gross tumor residual
No evidence of distant metastases
No synchronous or concurrent head and neck primary tumors
Karnofsky score over 60
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
Signed written informed consent
Exclusion Criteria:
Evidence of distant metastasis
Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
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
Learn more about this trial
Concurrent Chemotherapy Based on Genetic Testing in Patients With High-Risk Salivary Gland Tumors
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