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Postoperative Concurrent Chemoradiotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors

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ClinicalTrials.gov Identifier: NCT02776163
Recruitment Status : Recruiting
First Posted : May 18, 2016
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Guopei Zhu, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Brief Summary:
This is a non-randomized, phase II, open label study of postoperative current chemoradiotherapy for high-risk malignant salivary gland tumors of head and neck.The primary purpose of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy in these patients.

Condition or disease Intervention/treatment Phase
Salivary Gland Tumors Head and Neck Cancer Drug: Cisplatin Drug: Docetaxel Radiation: Intensity-modulated radiotherapy Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Postoperative Concurrent Chemoradiotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors of Head and Neck, A Non-Randomized, Phase II Trial
Actual Study Start Date : June 1, 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cisplatin Group
Intensity-modulated radiotherapy+concurrent chemotherapy with cisplatin for squamous carcinoma of salivary gland
Drug: Cisplatin
Cisplatin 80mg/m^2,D1-3,2 cycles
Other Name: Platinol

Radiation: Intensity-modulated radiotherapy
a total dose of 60-66Gy in 30-32 fractions over 6-7 weeks

Experimental: Docetaxel+Cisplatin
Intensity-modulated radiotherapy+concurrent chemotherapy with docetaxel and cisplatin for adenogenous types carcinoma of salivary gland
Drug: Cisplatin
Cisplatin 80mg/m^2,D1-3,2 cycles
Other Name: Platinol

Drug: Docetaxel
Docetaxel 70mg/m^2,D1,2 cycles
Other Name: Taxotere

Radiation: Intensity-modulated radiotherapy
a total dose of 60-66Gy in 30-32 fractions over 6-7 weeks




Primary 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


Secondary Outcome Measures :
  1. Overall survival rate [ Time Frame: 2 years ]
    from date of enrollment until date of first death from any cause, assessed up to 2 years

  2. Acute toxicity profiles, graded according to the NCI CTCAE version 3.0 [ Time Frame: up to 6 weeks ]
    Number of participants with treatment-related acute toxicity as assessed weekly by CTCAE v3.0 during the course of treatment

  3. Late toxicity profiles, graded according to the NCI CTCAE version 3.0 [ Time Frame: up to 2 years ]
    Number of participants with treatment-related late toxicity as assessed every 3 months by CTCAE v3.0 up to 2 years

  4. Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Core 35 (EORTC QLQ-HN35) during the concurrent treatment [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks ]
    QoL score will be documented on each weekend during the course of radiotherapy



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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): NCT02776163


Contacts
Contact: Guopei Zhu, M.D. antica@gmail.com

Locations
China, Shanghai
Shanghai ninth people's hospital Recruiting
Shanghai, Shanghai, China, 200011
Contact: Guopei Zhu, M.D.         
Sponsors and Collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Investigators
Principal Investigator: Guopei Zhu, M.D. Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Responsible Party: Guopei Zhu, M.D., Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
ClinicalTrials.gov Identifier: NCT02776163     History of Changes
Other Study ID Numbers: 2016HNRT002
First Posted: May 18, 2016    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 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-an-Neck cancer
Concurrent Chemoradiotherapy
High-Risk
Cisplatin
Docetaxel

Additional relevant MeSH terms:
Head and Neck Neoplasms
Salivary Gland Neoplasms
Neoplasms by Site
Neoplasms
Mouth Neoplasms
Mouth Diseases
Stomatognathic Diseases
Salivary Gland Diseases
Docetaxel
Cisplatin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action