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

Primary Purpose

Head-and-neck Cancer, Squamous Cell Carcinoma

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Docetaxel

Intensity-modulated radiotherapy

About this trial

This is an interventional treatment trial for Head-and-neck Cancer focused on measuring Docetaxel, Concurrent Chemoradiotherapy, High-Risk, Squamous Cell Carcinoma, Head-and-Neck Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:
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
No evidence of distant metastases
No synchronous or concurrent head and neck primary tumors
Karnofsky score over 60
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
Signed written informed consent

Exclusion Criteria:

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

Sites / Locations

Shanghai ninth people's hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Docetaxel Group

Arm Description

Concurrent Chemoradiotherapy With Docetaxel

Outcomes

Primary Outcome Measures

Disease-free survival

from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years

Secondary Outcome Measures

overall survival rate

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

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

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

QoL score will be documented on each weekend during the course of radiotherapy

Full Information

NCT ID

NCT02776137

First Posted

May 11, 2016

Last Updated

August 17, 2020

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT02776137

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

March 2016 (Actual)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

February 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head-and-neck Cancer, Squamous Cell Carcinoma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

91 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Docetaxel Group

Arm Type

Experimental

Arm Description

Concurrent Chemoradiotherapy With Docetaxel

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Intervention Description

Docetaxel: 20mg/m2/w for 6 weeks

Intervention Type

Radiation

Intervention Name(s)

Intensity-modulated radiotherapy

Other Intervention Name(s)

IMRT

Intervention Description

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

Primary Outcome Measure Information:

Title

Disease-free survival

Description

from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years

Time Frame

2 years

Secondary Outcome Measure Information:

Title

overall survival rate

Description

from date of enrollment until date of first death from any cause, assessed up to 2 years

Time Frame

2 years

Title

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

Description

Number of participants with treatment-related acute toxicity as assessed weekly by CTCAE v3.0 during the course of treatment

Time Frame

up to 6-7 weeks

Title

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

Description

Number of participants with treatment-related late toxicity as assessed every 3 months by CTCAE v3.0 up to 2 years

Time Frame

up to 2 years

Title

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

Description

QoL score will be documented on each weekend during the course of radiotherapy

Time Frame

participants will be followed for the duration of hospital stay, an expected average of 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Serum creatine <= 1 times ULN Signed written informed consent Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guopei Zhu, M.D.

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shanghai ninth people's hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200011

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

32126267

Citation

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.

Results Reference

derived

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

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