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

Shanghai Jiao Tong University

Status and phase: Completed; Phase 2

Conditions: Squamous Cell Carcinoma; Head-and-neck Cancer

Treatments: Radiation: Intensity-modulated radiotherapy; Drug: Docetaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT02776137

2016HNRT001

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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91 participants in 1 patient group

Docetaxel Group

Experimental group

Description:

Concurrent Chemoradiotherapy With Docetaxel

Treatment:

Radiation: Intensity-modulated radiotherapy

Drug: Docetaxel