Postoperative Concurrent Chemoradiotherapy With Docetaxel for High-Risk Squamous Cell Carcinoma of Head and Neck

Squamous Cell Carcinoma Clinical Trial

Official title:

Postoperative Concurrent Chemoradiotherapy With Docetaxel for High-Risk Squamous Cell Carcinoma of Head and Neck，A Non-Randomized Phase II Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02776137
• Other study ID #: 2016HNRT001
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Head-and-neck Cancer
• Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

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