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Concurrent Chemotherapy Based on Genetic Testing in Patients With High-Risk Salivary Gland Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02921984
Recruitment Status : Completed
First Posted : October 3, 2016
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Guopei Zhu, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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.

Condition or disease Intervention/treatment Phase
Salivary Gland Tumors Head and Neck Cancer Drug: Docetaxel Radiation: Intensity-modulated radiotherapy Drug: Pemetrexed Drug: Cisplatin Phase 1

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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

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Arm Intervention/treatment
Experimental: Docetaxel arm
Concurrent chemotherapy with Docetaxel if genetic testing show that the patient should be sensitive to this drug.
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.
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
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




Primary Outcome Measures :
  1. Acute toxicity profiles, graded according to the NCI CTCAE version 3.0 [ Time Frame: up to 6 weeks ]

Secondary Outcome Measures :
  1. 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
Criteria

Inclusion Criteria:

  1. Pathologically proven diagnosis of a malignant salivary gland tumor of intermediate or high-grade
  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:

  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

Information from the National Library of Medicine

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


Locations
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China, Shanghai
Shanghai ninth people's hospital
Shanghai, Shanghai, China, 200011
Sponsors and Collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Investigators
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Study Chair: Guopei Zhu Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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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
Keywords provided by Guopei Zhu, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University:
Salivary Gland Tumors
Head and Neck Cancer
concurrent chemotherapy
genetic testing
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Salivary Gland Neoplasms
Neoplasms
Neoplasms by Site
Mouth Neoplasms
Mouth Diseases
Stomatognathic Diseases
Salivary Gland Diseases
Cisplatin
Docetaxel
Pemetrexed
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors