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

Shanghai Jiao Tong University

Status and phase: Completed; Phase 1

Conditions: Salivary Gland Tumors; Head and Neck Cancer

Treatments: Radiation: Intensity-modulated radiotherapy; Drug: Cisplatin; Drug: Docetaxel; Drug: Pemetrexed

Study type: Interventional

Funder types: Other

Identifiers

NCT02921984

2013HNRT01

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 3 patient groups

Docetaxel arm

Experimental group

Description:

Concurrent chemotherapy with Docetaxel if genetic testing show that the patient should be sensitive to this drug.

Treatment:

Radiation: Intensity-modulated radiotherapy

Drug: Docetaxel

Pemetrexed arm

Experimental group

Description:

Concurrent chemotherapy with Pemetrexed if genetic testing show that the patient should be sensitive to this drug.

Treatment:

Drug: Pemetrexed

Radiation: Intensity-modulated radiotherapy

Cisplatin arm

Experimental group

Description:

Concurrent chemotherapy with Cisplatin if genetic testing show that the patient was nor sensitive to neither Pemetrexed nor Docetaxel

Treatment:

Radiation: Intensity-modulated radiotherapy

Drug: Cisplatin