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

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02776163

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Salivary Gland Tumors Head and Neck Cancer	Drug: Cisplatin Drug: Docetaxel Radiation: Intensity-modulated radiotherapy	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

53 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Postoperative Concurrent Chemoradiotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors of Head and Neck, A Non-Randomized, Phase II Trial

Actual Study Start Date :

Jun 1, 2016

Anticipated Primary Completion Date :

May 1, 2019

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cisplatin Group Intensity-modulated radiotherapy+concurrent chemotherapy with cisplatin for squamous carcinoma of salivary gland	Drug: Cisplatin Cisplatin 80mg/m^2，D1-3，2 cycles Other Names: Platinol Radiation: Intensity-modulated radiotherapy a total dose of 60-66Gy in 30-32 fractions over 6-7 weeks
Experimental: Docetaxel+Cisplatin Intensity-modulated radiotherapy+concurrent chemotherapy with docetaxel and cisplatin for adenogenous types carcinoma of salivary gland	Drug: Cisplatin Cisplatin 80mg/m^2，D1-3，2 cycles Other Names: Platinol Drug: Docetaxel Docetaxel 70mg/m^2，D1，2 cycles Other Names: Taxotere Radiation: Intensity-modulated radiotherapy a total dose of 60-66Gy in 30-32 fractions over 6-7 weeks

Arm

Intervention/Treatment

Experimental: Cisplatin Group

Intensity-modulated radiotherapy+concurrent chemotherapy with cisplatin for squamous carcinoma of salivary gland

Drug: Cisplatin

Cisplatin 80mg/m^2，D1-3，2 cycles

Other Names:

Platinol

Radiation: Intensity-modulated radiotherapy

a total dose of 60-66Gy in 30-32 fractions over 6-7 weeks

Experimental: Docetaxel+Cisplatin

Intensity-modulated radiotherapy+concurrent chemotherapy with docetaxel and cisplatin for adenogenous types carcinoma of salivary gland

Drug: Cisplatin

Cisplatin 80mg/m^2，D1-3，2 cycles

Other Names:

Platinol

Drug: Docetaxel

Docetaxel 70mg/m^2，D1，2 cycles

Other Names:

Taxotere

Radiation: Intensity-modulated radiotherapy

a total dose of 60-66Gy in 30-32 fractions over 6-7 weeks

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Overall survival rate [2 years]
from date of enrollment until date of first death from any cause, assessed up to 2 years
Acute toxicity profiles, graded according to the NCI CTCAE version 3.0 [up to 6 weeks]
Number of participants with treatment-related acute toxicity as assessed weekly by CTCAE v3.0 during the course of treatment
Late toxicity profiles, graded according to the NCI CTCAE version 3.0 [up to 2 years]
Number of participants with treatment-related late toxicity as assessed every 3 months by CTCAE v3.0 up to 2 years
Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Core 35 (EORTC QLQ-HN35) during the concurrent treatment [participants will be followed for the duration of hospital stay, an expected average of 6 weeks]
QoL score will be documented on each weekend during the course of radiotherapy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Pathologically proven diagnosis of a malignant salivary gland tumor of intermediate or high-grade
Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (≤ 5mm) or microscopically positive surgical margin
Surgical resection with curative intent within 8 weeks prior to registration, with no evidence of gross tumor residual
No evidence of distant metastases
No synchronous or concurrent head and neck primary tumors
Karnofsky score over 60
Adequate organ function including the following:
Absolute neutrophil count (ANC) >= 1.5 * 10^9/l
Platelets count >= 100 * 10^9/l
Hemoglobin >= 10 g/dl
AST and ALT <= 2.5 times institutional upper limit of normal (ULN)
Total bilirubin <= 1.5 times institutional ULN
Creatinine clearance >= 50 ml/min
Serum creatine <= 1 times ULN
Signed written informed consent

Exclusion Criteria:

Evidence of distant metastasis
Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
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