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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02921984
Other study ID # 2013HNRT01
Secondary ID
Status Completed
Phase Phase 1
First received September 30, 2016
Last updated March 16, 2018
Start date September 2013
Est. completion date August 2017

Study information

Verified date March 2018
Source Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date August 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Intervention

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
Drug:
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

Locations

Country Name City State
China Shanghai ninth people's hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acute toxicity profiles, graded according to the NCI CTCAE version 3.0 up to 6 weeks
Secondary Disease-free survival from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years 2 years
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