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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02776163
• Other study ID #: 2016HNRT002
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2016
• Est. completion date: December 2020

Study information

• Verified date: September 2018
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: Guopei Zhu, M.D.
• Email: antica[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 53
• Est. completion date: December 2020
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Salivary Gland Neoplasms
• Salivary Gland Tumors

Intervention

Drug:
• Cisplatin
Cisplatin 80mg/m^2,D1-3,2 cycles
• Docetaxel
Docetaxel 70mg/m^2,D1,2 cycles

Radiation:
• Intensity-modulated radiotherapy
a total dose of 60-66Gy in 30-32 fractions over 6-7 weeks

Locations

Country	Name	City	State
China	Shanghai ninth people's hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival rate	from date of enrollment until date of first death from any cause, assessed up to 2 years	2 years
Secondary	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
Secondary	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
Secondary	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