Concurrent Chemotherapy Based on Genetic Testing in Patients With High-Risk Salivary Gland Tumors
NCT ID: NCT02921984
Last Updated: 2018-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2013-09-30
2017-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Docetaxel arm
Concurrent chemotherapy with Docetaxel if genetic testing show that the patient should be sensitive to this drug.
Docetaxel
Docetaxel only: 80 mg/m2 on day one, every 21 days if
Intensity-modulated radiotherapy
a total dose of 60-66Gy in 30-32 fractions over 6-7 weeks
Pemetrexed arm
Concurrent chemotherapy with Pemetrexed if genetic testing show that the patient should be sensitive to this drug.
Intensity-modulated radiotherapy
a total dose of 60-66Gy in 30-32 fractions over 6-7 weeks
Pemetrexed
Pemetrexed only: 500 mg/m2 on day one, every 21 days
Cisplatin arm
Concurrent chemotherapy with Cisplatin if genetic testing show that the patient was nor sensitive to neither Pemetrexed nor Docetaxel
Intensity-modulated radiotherapy
a total dose of 60-66Gy in 30-32 fractions over 6-7 weeks
Cisplatin
Cisplatin only: 70 mg/m2 on day one to day three, every 21 days
Interventions
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Docetaxel
Docetaxel only: 80 mg/m2 on day one, every 21 days if
Intensity-modulated radiotherapy
a total dose of 60-66Gy in 30-32 fractions over 6-7 weeks
Pemetrexed
Pemetrexed only: 500 mg/m2 on day one, every 21 days
Cisplatin
Cisplatin only: 70 mg/m2 on day one to day three, every 21 days
Eligibility Criteria
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Inclusion Criteria
2. Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (≤ 5mm) or microscopically positive surgical margin
3. Surgical resection with curative intent within 8 weeks prior to registration, with no evidence of gross tumor residual
4. No evidence of distant metastases
5. No synchronous or concurrent head and neck primary tumors
6. Karnofsky score over 60
7. Adequate organ function including the following:
1. Absolute neutrophil count (ANC) \>= 1.5 \* 10\^9/l
2. Platelets count \>= 100 \* 10\^9/l
3. Hemoglobin \>= 10 g/dl
4. AST and ALT \<= 2.5 times institutional upper limit of normal (ULN)
5. Total bilirubin \<= 1.5 times institutional ULN
6. Creatinine clearance \>= 50 ml/min
7. Serum creatine \<= 1 times ULN
8. Signed written informed consent
Exclusion Criteria
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
18 Years
70 Years
ALL
No
Sponsors
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Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
OTHER
Responsible Party
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Guopei Zhu
MD
Principal Investigators
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Guopei Zhu
Role: STUDY_CHAIR
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Locations
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Shanghai ninth people's hospital
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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2013HNRT01
Identifier Type: -
Identifier Source: org_study_id
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