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

• ClinicalTrials.gov Identifier: NCT02921984
• Recruitment Status: Completed
• First Posted: October 3, 2016
• Last Update Posted: March 20, 2018
• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Information provided by (Responsible Party): Guopei Zhu, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Study Chair: Guopei Zhu; Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

More Information

• 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
• 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:

Head and Neck Neoplasms; Salivary Gland Neoplasms; Neoplasms; Neoplasms by Site; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Docetaxel; Pemetrexed; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors