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Docetaxel and Loplatin Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced SCCHN

Primary Purpose

Locally Advanced Head and Neck Squamous Cell Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Lobaplatin

Cisplatin

About this trial

This is an interventional treatment trial for Locally Advanced Head and Neck Squamous Cell Carcinoma focused on measuring Lobaplatin, head and neck cancer, chronic-chemotherapy

Eligibility Criteria

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

Inclusion Criteria:

Voluntary participation and written informed consent
Age 18-70 years old, gender is not limited
histologically proved to be squamous cell carcinoma
No surgery: head and neck squamous cell carcinoma 2010UICC staging Ⅲ - ⅣA, ⅣB period.
After surgery: 2010UICC staging ⅣA, ⅣB;stage III tongue base or hypopharyngeal primaries;Postoperative naked eye or image residual stage III patients
Karnofsky score ≥70
Survival is expected to be ≥ 6 months
Women of childbearing age should be guaranteed contraception during the study period
(WBC) ≥4 × 109 / L * (unit normal), platelet (PLT) ≥100 × 109 / L (unit normal value), neutrophil cell (WBC), hematocrit (WBC) ≥1.5 × 109 / L * (unit normal value)
liver function: alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT) <upper limit of normal (ULN) 1.5 times; total bilirubin <1.5 × ULN
renal function: serum creatinine <1.5 × ULN, endogenous creatinine clearance rate (Ccr) ≥ 55 ml / min
no serious complications such as hypertension, diabetes, coronary heart disease and psychiatric history
The treatment for the first course of treatment (no head and neck radiotherapy, no chemotherapy within 3 months).

Exclusion Criteria:

There is a distant shift
primary lesions or lymph nodes were radiotherapy
had received epidermal growth factor targeted therapy
primary tumor had received chemotherapy or immunotherapy
had other malignancies (except for cured basal cell carcinoma or cervical cancer)
pregnant women or lactating women and treatment during the observation period of contraceptive women of childbearing age
have a serious history of allergies or specific physical
Abuse of drugs or alcohol addicts
Person who has personality or mental illness, no civil capacity or limited civil capacity

Sites / Locations

Cancer Hospital of Guizhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

the treatment group

the control group

Arm Description

docetaxel plus lobaplatin induction chemotherapy combined with lopoplatin chemoradiotherapy

TPF induction chemotherapy combined with cisplatin chemoradiotherapy

Outcomes

Primary Outcome Measures

National Cancer Institute CTCAE v4.0

Acute toxicity of radiotherapy and chemotherapy

evaluation of immediate efficacy

Evaluation of efficacy by RESIST1.1 standard

Secondary Outcome Measures

overall survival

Evaluate the Overall survival at five years after Concurrent chemo-radiotherapy by RECIST.

progression-free survival

Evaluate the Progression-free survival at five years after Concurrent chemo-radiotherapy by RECIST.

Full Information

NCT ID

NCT03117257

First Posted

April 2, 2017

Last Updated

April 14, 2017

Sponsor

Guiyang Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03117257

Brief Title

Docetaxel and Loplatin Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced SCCHN

Official Title

A Prospective Phase II Randomized Clinical Trial: Docetaxel and Loplatin Induction Chemotherapy Followed by Concurrent Lobaplatin Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Unknown status

Study Start Date

August 19, 2016 (Actual)

Primary Completion Date

August 19, 2019 (Anticipated)

Study Completion Date

August 20, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guiyang Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is to observe and compare the safety and tolerability of docetaxel plus lobaplatin induction chemotherapy combined with lopoplatin chemoradiotherapy and TPF induction chemotherapy combined with cisplatin chemoradiotherapy in the treatment of locally advanced head and neck squamous cell carcinoma.

Detailed Description

TPF program is currently the local advanced head and neck squamous cell carcinoma commonly used inducing chemotherapy, cisplatin is the preferred drug for the same period chemotherapy, however, due to heavier gastrointestinal reactions caused by cisplatin， direct damage to renal parenchymal and other adverse reactions often lead to anti-tumor therapy can not be smooth Carried out, resulting in treatment failure, thus affecting the survival of patients. Therefore, how to improve the efficacy of the same time to reduce adverse drug reactions, as a prominent problem. Lobaplatin as the third generation of platinum antitumor drugs, anti-cancer activity and cisplatin rather, more than carboplatin. In this study, Phase II clinical trials were performed. Patients with locally advanced head and neck squamous cell carcinoma were randomly divided into experimental group and control group. The trial group was treated with docetaxel + lorosine-induced chemotherapy combined with lorplatin concurrent radiotherapy and chemotherapy. The control group was treated with TPF Cisplatin concurrent chemotherapy, observed and compared the efficacy and toxicity of the two treatment to assess its safety and patient tolerance.

6. Conditions and Keywords

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

Locally Advanced Head and Neck Squamous Cell Carcinoma

Keywords

Lobaplatin, head and neck cancer, chronic-chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

the treatment group

Arm Type

Experimental

Arm Description

docetaxel plus lobaplatin induction chemotherapy combined with lopoplatin chemoradiotherapy

Arm Title

the control group

Arm Type

Active Comparator

Arm Description

TPF induction chemotherapy combined with cisplatin chemoradiotherapy

Intervention Type

Drug

Intervention Name(s)

Lobaplatin

Other Intervention Name(s)

Platinum

Intervention Description

Device: Chrono-chemotherapy Drug: induction Chrono-chemotherapy Drug: Lobaplatin chrono-chemotherapy Radiation: intensity-modulated radiation therapy

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

cis-DDP; cis-Diammineplatinum(II) dichloride;

Intervention Description

Device: Chrono-chemotherapy Drug: induction Chrono-chemotherapy Drug: cisplatin chrono-chemotherapy Radiation: intensity-modulated radiation therapy

Primary Outcome Measure Information:

Title

National Cancer Institute CTCAE v4.0

Description

Acute toxicity of radiotherapy and chemotherapy

Time Frame

1 year

Title

evaluation of immediate efficacy

Description

Evaluation of efficacy by RESIST1.1 standard

Time Frame

1 year

Secondary Outcome Measure Information:

Title

overall survival

Description

Evaluate the Overall survival at five years after Concurrent chemo-radiotherapy by RECIST.

Time Frame

5 years

Title

progression-free survival

Description

Evaluate the Progression-free survival at five years after Concurrent chemo-radiotherapy by RECIST.

Time Frame

5 years

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: Voluntary participation and written informed consent Age 18-70 years old, gender is not limited histologically proved to be squamous cell carcinoma No surgery: head and neck squamous cell carcinoma 2010UICC staging Ⅲ - ⅣA, ⅣB period. After surgery: 2010UICC staging ⅣA, ⅣB;stage III tongue base or hypopharyngeal primaries;Postoperative naked eye or image residual stage III patients Karnofsky score ≥70 Survival is expected to be ≥ 6 months Women of childbearing age should be guaranteed contraception during the study period (WBC) ≥4 × 109 / L * (unit normal), platelet (PLT) ≥100 × 109 / L (unit normal value), neutrophil cell (WBC), hematocrit (WBC) ≥1.5 × 109 / L * (unit normal value) liver function: alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT) <upper limit of normal (ULN) 1.5 times; total bilirubin <1.5 × ULN renal function: serum creatinine <1.5 × ULN, endogenous creatinine clearance rate (Ccr) ≥ 55 ml / min no serious complications such as hypertension, diabetes, coronary heart disease and psychiatric history The treatment for the first course of treatment (no head and neck radiotherapy, no chemotherapy within 3 months). Exclusion Criteria: There is a distant shift primary lesions or lymph nodes were radiotherapy had received epidermal growth factor targeted therapy primary tumor had received chemotherapy or immunotherapy had other malignancies (except for cured basal cell carcinoma or cervical cancer) pregnant women or lactating women and treatment during the observation period of contraceptive women of childbearing age have a serious history of allergies or specific physical Abuse of drugs or alcohol addicts Person who has personality or mental illness, no civil capacity or limited civil capacity

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Feng Jin, Bachelor

Phone

86-851-86512802

jinf8865@yeah.net

First Name & Middle Initial & Last Name or Official Title & Degree

Weili Wu, master

Phone

86-13885124077

wwlmhy@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Feng Jin, Bachelor

Organizational Affiliation

Guizhou Provincial Cancer Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Cancer Hospital of Guizhou Medical University

City

Guiyang

State/Province

Guizhou

ZIP/Postal Code

550000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Feng Jin, Bachelor

Phone

0851-86512802

jinf8865@yahoo.com.cn

First Name & Middle Initial & Last Name & Degree

Weili Wu, master

First Name & Middle Initial & Last Name & Degree

Jinhua Long, master

First Name & Middle Initial & Last Name & Degree

Yuanyuan Li, master

First Name & Middle Initial & Last Name & Degree

Xiuyun Gong, Bachelor

First Name & Middle Initial & Last Name & Degree

Xiaoxiao Chen, Bachelor

First Name & Middle Initial & Last Name & Degree

Mang Zhang, Bachelor

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Docetaxel and Loplatin Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced SCCHN

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