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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02921984
• Other study ID #: 2013HNRT01
• 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
• 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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Salivary Gland Neoplasms
• Salivary Gland Tumors

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