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

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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer; Salivary Gland Tumors
• Intervention / Treatment: Drug: Docetaxel; Drug: Nedaplatin; Radiation: Intensity-modulated radiotherapy

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • Shanghai Ninth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACC; Intensity-modulated radiotherapy+concurrent chemotherapy with docetaxel and Nedaplatin	Drug: Docetaxel; Docetaxel 70mg/m^2，D1，2 cycles; Other Names: Taxotere; Drug: Nedaplatin; nedaplatin 35mg/m^2，D1-2，2 cycles; Radiation: Intensity-modulated radiotherapy; a total dose of 60-66Gy in 30-33 fractions over 6-7 weeks
Experimental: Non-ACC; Intensity-modulated radiotherapy+concurrent chemotherapy with docetaxel and Nedaplatin	Drug: Docetaxel; Docetaxel 70mg/m^2，D1，2 cycles; Other Names: Taxotere; Drug: Nedaplatin; nedaplatin 35mg/m^2，D1-2，2 cycles; Radiation: Intensity-modulated radiotherapy; a total dose of 60-66Gy in 30-33 fractions over 6-7 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival	from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival rate	from date of enrollment until date of first death from any cause, assessed up to 2 years	2 years
Acute toxicity profiles, graded according to the NCI CTCAE version 3.0	Number of participants with treatment-related acute toxicity as assessed weekly by CTCAE v3.0 during the course of treatment	up to 6 weeks
Late toxicity profiles, graded according to the NCI CTCAE version 3.0	Number of participants with treatment-related late toxicity as assessed every 3 months by CTCAE v3.0 up to 2 years	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	QoL score will be documented on each weekend during the course of radiotherapy	participants will be followed for the duration of hospital stay, an expected average of 6 weeks

Collaborators and Investigators

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Investigators: Principal Investigator: Guopei Zhu, M.D., Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: May 12, 2016
• First Submitted That Met QC Criteria: May 15, 2016
• First Posted (Estimated): May 18, 2016

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 26, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Docetaxel; Cisplatin; Concurrent Chemoradiotherapy; High-Risk; Salivary Gland Tumors; Head-an-Neck cancer
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Mouth Neoplasms; Head and Neck Neoplasms; Salivary Gland Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Nedaplatin
• Other Study ID Numbers: 2016HNRT002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO