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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer; Salivary Gland Tumors
• Intervention / Treatment: Radiation: Intensity-modulated radiotherapy; Drug: Docetaxel; Drug: Pemetrexed; Drug: Cisplatin

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • Shanghai Ninth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Docetaxel arm; Concurrent chemotherapy with Docetaxel 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: Docetaxel; Docetaxel only: 80 mg/m2 on day one, every 21 days if
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Acute toxicity profiles, graded according to the NCI CTCAE version 3.0	up to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2013
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: September 30, 2016
• First Submitted That Met QC Criteria: September 30, 2016
• First Posted (Estimate): October 3, 2016

Study Record Updates

• Last Update Posted (Actual): March 20, 2018
• Last Update Submitted That Met QC Criteria: March 16, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Head and Neck Cancer; genetic testing; concurrent chemotherapy; Salivary Gland Tumors
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Mouth Neoplasms; Head and Neck Neoplasms; Salivary Gland Neoplasms; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Folic Acid Antagonists; Docetaxel; Cisplatin; Pemetrexed
• Other Study ID Numbers: 2013HNRT01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO