Concurrent Chemotherapy Based on Genetic Testing in Patients With High-Risk Salivary Gland Tumors
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ClinicalTrials.gov Identifier: NCT02921984 |
Recruitment Status :
Completed
First Posted : October 3, 2016
Last Update Posted : March 20, 2018
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Condition or disease | Intervention/treatment | Phase |
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Salivary Gland Tumors Head and Neck Cancer | Drug: Docetaxel Radiation: Intensity-modulated radiotherapy Drug: Pemetrexed Drug: Cisplatin | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Concurrent Chemotherapy Based on Genetic Testing in Patients With High-Risk Salivary Gland Tumors |
Actual Study Start Date : | September 2013 |
Actual Primary Completion Date : | December 2016 |
Actual Study Completion Date : | August 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Docetaxel arm
Concurrent chemotherapy with Docetaxel if genetic testing show that the patient should be sensitive to this drug.
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Drug: Docetaxel
Docetaxel only: 80 mg/m2 on day one, every 21 days if Radiation: Intensity-modulated radiotherapy a total dose of 60-66Gy in 30-32 fractions over 6-7 weeks |
Experimental: Pemetrexed arm
Concurrent chemotherapy with Pemetrexed if genetic testing show that the patient should be sensitive to this drug.
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Radiation: Intensity-modulated radiotherapy
a total dose of 60-66Gy in 30-32 fractions over 6-7 weeks Drug: Pemetrexed Pemetrexed only: 500 mg/m2 on day one, every 21 days |
Experimental: Cisplatin arm
Concurrent chemotherapy with Cisplatin if genetic testing show that the patient was nor sensitive to neither Pemetrexed nor Docetaxel
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Radiation: Intensity-modulated radiotherapy
a total dose of 60-66Gy in 30-32 fractions over 6-7 weeks Drug: Cisplatin Cisplatin only: 70 mg/m2 on day one to day three, every 21 days |
- Acute toxicity profiles, graded according to the NCI CTCAE version 3.0 [ Time Frame: up to 6 weeks ]
- Disease-free survival [ Time Frame: 2 years ]from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02921984
China, Shanghai | |
Shanghai ninth people's hospital | |
Shanghai, Shanghai, China, 200011 |
Study Chair: | Guopei Zhu | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University |
Responsible Party: | Guopei Zhu, MD, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University |
ClinicalTrials.gov Identifier: | NCT02921984 |
Other Study ID Numbers: |
2013HNRT01 |
First Posted: | October 3, 2016 Key Record Dates |
Last Update Posted: | March 20, 2018 |
Last Verified: | March 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Salivary Gland Tumors Head and Neck Cancer concurrent chemotherapy genetic testing |
Head and Neck Neoplasms Salivary Gland Neoplasms Neoplasms Neoplasms by Site Mouth Neoplasms Mouth Diseases Stomatognathic Diseases Salivary Gland Diseases Docetaxel |
Pemetrexed Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |