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

Phase 1

Completed

• Conditions: Salivary Gland Tumors; Head and Neck Cancer
• Interventions: Radiation: Intensity-modulated radiotherapy; Drug: Docetaxel; Drug: Pemetrexed; Drug: Cisplatin

• Registration Number: NCT02921984
• Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2016-09-30
• Study First Submitted QC: 2016-09-30
• Study First Posted: 2016-10-03
• Primary Completion: 2016-12
• Study Completion: 2017-08
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-16
• Last Update Posted: 2018-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cisplatin arm	Intensity-modulated radiotherapy	Concurrent chemotherapy with Cisplatin if genetic testing show that the patient was nor sensitive to neither Pemetrexed nor Docetaxel
Docetaxel arm	Intensity-modulated radiotherapy	Concurrent chemotherapy with Docetaxel if genetic testing show that the patient should be sensitive to this drug.
Pemetrexed arm	Intensity-modulated radiotherapy	Concurrent chemotherapy with Pemetrexed if genetic testing show that the patient should be sensitive to this drug.
Pemetrexed arm	Pemetrexed	Concurrent chemotherapy with Pemetrexed if genetic testing show that the patient should be sensitive to this drug.
Docetaxel arm	Docetaxel	Concurrent chemotherapy with Docetaxel if genetic testing show that the patient should be sensitive to this drug.
Cisplatin arm	Cisplatin	Concurrent chemotherapy with Cisplatin if genetic testing show that the patient was nor sensitive to neither Pemetrexed nor Docetaxel

Primary Outcome Measures

Name	Time	Method
Acute toxicity profiles, graded according to the NCI CTCAE version 3.0	up to 6 weeks

Secondary Outcome Measures

Name	Time	Method
Disease-free survival	2 years	from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years

Trial Locations

Locations (1)

Shanghai ninth people's hospital; 🇨🇳 Shanghai, Shanghai, China