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

Phase 2

Completed

• Conditions: Head-and-neck Cancer; Squamous Cell Carcinoma
• Interventions: Drug: Docetaxel; Radiation: Intensity-modulated radiotherapy

• Registration Number: NCT02776137
• 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-05-11
• Study First Submitted QC: 2016-05-15
• Study First Posted: 2016-05-18
• Primary Completion: 2017-12
• Study Completion: 2019-02
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-17
• Last Update Posted: 2020-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Docetaxel Group	Intensity-modulated radiotherapy	Concurrent Chemoradiotherapy With Docetaxel
Docetaxel Group	Docetaxel	Concurrent Chemoradiotherapy With Docetaxel

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
overall survival rate	2 years	from date of enrollment until date of first death from any cause, assessed up to 2 years
Acute toxicity profiles, graded according to the NCI CTCAE version 3.0	up to 6-7 weeks	Number of participants with treatment-related acute toxicity as assessed weekly by CTCAE v3.0 during the course of treatment
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
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

Trial Locations

Locations (1)

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