Postoperative Concurrent Chemoradiotherapy in Treating Patients With High-Risk Salivary Gland Carcinomas

Shanghai Jiao Tong University

Status and phase: Completed; Phase 2

Conditions: Salivary Gland Tumors; Head and Neck Cancer

Treatments: Drug: Docetaxel; Drug: Nedaplatin; Radiation: Intensity-modulated radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02776163

2016HNRT002

Details and patient eligibility

About

This is a non-randomized, phase II, open label study of postoperative current chemoradiotherapy for high-risk malignant salivary gland tumors of head and neck.The primary purpose of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy in these patients.

Enrollment: 107 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: Single Group Assignment

Masking: None (Open label)

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107 participants in 2 patient groups

ACC

Experimental group

Description:

Intensity-modulated radiotherapy+concurrent chemotherapy with docetaxel and Nedaplatin

Treatment:

Radiation: Intensity-modulated radiotherapy

Drug: Docetaxel

Drug: Nedaplatin

Non-ACC

Experimental group

Description:

Intensity-modulated radiotherapy+concurrent chemotherapy with docetaxel and Nedaplatin

Treatment:

Radiation: Intensity-modulated radiotherapy

Drug: Docetaxel

Drug: Nedaplatin