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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02776137
Other study ID # 2016HNRT001
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 2016
Est. completion date February 2019

Study information

Verified date August 2020
Source Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a non-randomized, phase II, open label study of postoperative concurrent chemoradiotherapy with docetaxel for high-risk squamous cell carcinoma of the head and neck(HNSCC).The primary purpose of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy with docetaxel in HNSCC patients.


Recruitment information / eligibility

Status Completed
Enrollment 91
Est. completion date February 2019
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

1. Histologically confirmed squamous cell carcinoma of the head and neck.Site of tumor origin in the oral cavity, oropharynx, larynx, or hypopharynx (excluding nasopharynx, or sinuses)

2. Gross total resection, with pathology demonstrating one or more of the following risk factors:

1. Histologic extracapsular nodal extension

2. Histologic involvement of = 2 regional lymph nodes

3. Invasive cancer seen on microscopic evaluation of the resection margin, with no evidence of gross tumor residual

3. No evidence of distant metastases

4. No synchronous or concurrent head and neck primary tumors

5. Karnofsky score over 60

6. 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

7. 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


Related Conditions & MeSH terms


Intervention

Drug:
Docetaxel
Docetaxel: 20mg/m2/w for 6 weeks
Radiation:
Intensity-modulated radiotherapy
a total dose of 60Gy in 30 fractions over 6 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 6-7 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
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