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

NCT02776137 | Completed Phase 2 DMC

• 1 other identifier: 2016HNRT001
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Head-and-neck Cancer; Squamous Cell Carcinoma

Keywords

Docetaxel; Concurrent Chemoradiotherapy; High-Risk; Squamous Cell Carcinoma; Head-and-Neck Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• overall survival rate

  2 years

• Acute toxicity profiles, graded according to the NCI CTCAE version 3.0

  up to 6-7 weeks

• Late toxicity profiles, graded according to the NCI CTCAE version 3.0

  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

Study Arms (1)

Docetaxel Group

EXPERIMENTAL

Concurrent Chemoradiotherapy With Docetaxel

Drug: Docetaxel; Radiation: Intensity-modulated radiotherapy

Interventions

Docetaxel DRUG

Docetaxel: 20mg/m2/w for 6 weeks

Docetaxel Group

Intensity-modulated radiotherapy RADIATION

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

Also known as: IMRT

Docetaxel Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Gross total resection, with pathology demonstrating one or more of the following risk factors:
• Histologic extracapsular nodal extension
• Histologic involvement of ≥ 2 regional lymph nodes
• Invasive cancer seen on microscopic evaluation of the resection margin, with no evidence of gross tumor residual
• No evidence of distant metastases
• No synchronous or concurrent head and neck primary tumors
• Karnofsky score over 60
• Adequate organ function including the following:
• Absolute neutrophil count (ANC) \>= 1.5 \* 10\^9/l
• Platelets count \>= 100 \* 10\^9/l
• Hemoglobin \>= 10 g/dl
• AST and ALT \<= 2.5 times institutional upper limit of normal (ULN)
• Total bilirubin \<= 1.5 times institutional ULN
• Creatinine clearance \>= 50 ml/min

You may not qualify if:

• Evidence of distant metastasis
• Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
• Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
• Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
• 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

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Shanghai ninth people's hospital

Shanghai, Shanghai Municipality, 200011, China

Location

Related Publications (1)

• Li R, Jiang W, Dou S, Zhong L, Sun J, Zhang C, Zhu G. A Phase 2 Trial of Chemoradiation Therapy Using Weekly Docetaxel for High-Risk Postoperative Oral Squamous Cell Carcinoma Patients. Int J Radiat Oncol Biol Phys. 2020 Jul 1;107(3):462-468. doi: 10.1016/j.ijrobp.2020.02.464. Epub 2020 Feb 29.

  PMID: 32126267 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Carcinoma, Squamous Cell

Interventions

Docetaxel; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Guopei Zhu, M.D.

  Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: May 18, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: February 1, 2019
• Last Updated: August 19, 2020

Record last verified: 2020-08

Locations

CN (1)