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

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02921984
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 3
• Actual Duration (Months): 47
• Patients Per Site Per Month: 0.4

Study Details

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
• 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: Sep 1, 2013
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Aug 1, 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 [up to 6 weeks]

Secondary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

8. Absolute neutrophil count (ANC) >= 1.5 * 10^9/l

9. Platelets count >= 100 * 10^9/l

10. Hemoglobin >= 10 g/dl

11. AST and ALT <= 2.5 times institutional upper limit of normal (ULN)

12. Total bilirubin <= 1.5 times institutional ULN

13. Creatinine clearance >= 50 ml/min

14. Serum creatine <= 1 times ULN

15. 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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Oct 3, 2016
• Last Update Posted: Mar 20, 2018
• Last Verified: Mar 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Guopei Zhu, MD, 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; Docetaxel; Pemetrexed

Study Results

No Results Posted as of Mar 20, 2018