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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2019-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02776163

Salivary Gland Tumors Head and Neck Cancer

COMPLETED PHASE2

Postoperative CCRT With Docetaxel vs Cisplatin in High Risk Oral Cavity Cancer

NCT02923258

Oral Cavity Squamous Cell Carcinoma

COMPLETED PHASE2/PHASE3

Docetaxel in Head and Neck Cancer

NCT00261703

Head and Neck Neoplasms

COMPLETED PHASE2/PHASE3

Treatment of Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck

NCT01086826

Head and Neck Squamous Cell Carcinoma

COMPLETED PHASE3

A Multicenter Phase II Trial of Post-operative Concurrent Chemoradiotherapy Using Weekly Cisplatin With Tislelizumab for Patients With High-risk Head and Neck Squamous Cell Carcinoma：The POTENTIAL Study

NCT04814069

Head and Neck Cancer Radiation PD-1

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Head-and-neck Cancer Squamous Cell Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Docetaxel Group

Concurrent Chemoradiotherapy With Docetaxel

Group Type EXPERIMENTAL

Docetaxel

Intervention Type DRUG

Docetaxel: 20mg/m2/w for 6 weeks

Intensity-modulated radiotherapy

Intervention Type RADIATION

a total dose of 60Gy in 30 fractions over 6 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Docetaxel

Docetaxel: 20mg/m2/w for 6 weeks

Intervention Type DRUG

Intensity-modulated radiotherapy

a total dose of 60Gy in 30 fractions over 6 weeks

Intervention Type RADIATION

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

IMRT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No