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

Phase 2

Completed

• Conditions: Salivary Gland Tumors; Head and Neck Cancer
• Interventions: Drug: Nedaplatin; Drug: Docetaxel; Radiation: Intensity-modulated radiotherapy

• Registration Number: NCT02776163
• Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-12
• Study First Submitted QC: 2016-05-15
• Study First Posted: 2016-05-18
• Study Start: 2016-06-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-26
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ACC	Intensity-modulated radiotherapy	Intensity-modulated radiotherapy+concurrent chemotherapy with docetaxel and Nedaplatin
ACC	Nedaplatin	Intensity-modulated radiotherapy+concurrent chemotherapy with docetaxel and Nedaplatin
ACC	Docetaxel	Intensity-modulated radiotherapy+concurrent chemotherapy with docetaxel and Nedaplatin
Non-ACC	Intensity-modulated radiotherapy	Intensity-modulated radiotherapy+concurrent chemotherapy with docetaxel and Nedaplatin
Non-ACC	Docetaxel	Intensity-modulated radiotherapy+concurrent chemotherapy with docetaxel and Nedaplatin
Non-ACC	Nedaplatin	Intensity-modulated radiotherapy+concurrent chemotherapy with docetaxel and Nedaplatin

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
Overall survival rate	2 years	from date of enrollment until date of first death from any cause, assessed up to 2 years
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

Trial Locations

Locations (1)

Shanghai ninth people's hospital; 🇨🇳 Shanghai, Shanghai, China