Clinical trial NCT02776163: Postoperative Concurrent Chemoradiotherapy in Treating Patients With High-Risk Salivary Gland Carcinomas
Official title: Postoperative Concurrent Chemoradiotherapy in Treating Patients With High-Risk Salivary Gland Carcinomas of Head and Neck, A Non-Randomized, Phase II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Salivary Gland Tumors
Head and Neck Cancer
Keywords: Salivary Gland Tumors
Head-an-Neck cancer
Concurrent Chemoradiotherapy
High-Risk
Cisplatin
Docetaxel
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2016-05-18
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Disease-free survival
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival rate
timeFrame: 2 years
measure: Acute toxicity profiles, graded according to the NCI CTCAE version 3.0
timeFrame: up to 6 weeks
measure: Late toxicity profiles, graded according to the NCI CTCAE version 3.0
timeFrame: up to 2 years
measure: 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
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai ninth people's hospital
state: Shanghai
Study officials:
affiliation: Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
name: Guopei Zhu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: