Back to results

Nimotuzumab for Recurrent Nasopharyngeal Carcinoma

Primary Purpose

Recurrent Nasopharyngeal Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Nimotuzumab

About this trial

This is an interventional treatment trial for Recurrent Nasopharyngeal Carcinoma focused on measuring Nimotuzumab, IMRT, Radiation, Recurrent, Nasopharyngeal Carcinoma

Eligibility Criteria

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

Inclusion Criteria:

Patients with recurrent tumor in nasopharynx with or without relapse cervical lymph nodes more than 6 months after initial radical treatment.
Recurrent nasopharyngeal cancer was confirmed by pathology, marginal recurrence can be diagnosed by imaging examinations.
Age 18-70.
At least one of the tumor lesions measurable.
Functional Status: PS (ECOG) > 0-1.
Normal Bone Marrow Function: White blood cell count > 4×109/L, hemoglobin >90g/L, and platelet count >100×109/L.
Normal Hepatic and Renal Function: Alanine Tminotransferase (ALT)/Aspartate Aminotransferase (AST) < 2.5 times the upper limit of normal (ULN), while total bilirubin (T-Bil) < 1.5 x ULN and serum creatinine < 1.5 x ULN.
Life expectancy of more than 6 months.
All the patients signed the informed consent.
Follow up regularly and comply with test requirements.

Exclusion Criteria:

Patients with recurrent cervical lymph nodes alone.
Evidence of distant metastasis
The relapse tumor has been treated with chemotherapy, radiotherapy, surgery, immunotherapy and other anti-tumor therapy.
Creatinine clearance < 30ml/min
Has received epidermal growth factor targeting therapy.
Second malignancy within 5 years(except of Non-melanoma Skin Cancer or carcinoma in situ of cervix).
Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc.
Active systemic infection.
History of Serious lung or heart disease.
Drug or alcohol addiction.
Persons without capacity for civil conduct or persons with limited capacity for civil conduct.
The patient has physical or mental disorders and is believed to be unable to fully or fully understand the possible complications of the study.
To receive chronic systemic immunotherapy or hormone therapy other than this study.
Women who are pregnant or breast feeding
Participation in other drugs clinical trials within 1 month.

Sites / Locations

Department of radiation oncology, Fujian cancer hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nimotuzumab plus IMRT

Arm Description

Patients with recurrent nasopharyngeal carcinoma were given an initial dose of nimotuzumab (200 mg) 7days before receiving concurrent intensity modulated radiation therapy(IMRT) , folowing weekly nimotuzumab (200 mg/week) for totally 8 weeks concurrent with IMRT.

Outcomes

Primary Outcome Measures

Tumor response rate after Nimotuzumab concurrent with radiotherapy for recurrent NPC patients

The response status (Complete Response + Partial Response) was evaluated according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Complete response was defined as disappearance of all target lesions, and Partial response was defined as at least a 30% reduction in the sum of the longest diameter of target lesions, taking as reference the baseline study.

Toxicity of this combined treatment for recurrent NPC patients

Adverse events of this combined modality treatment were graded according to CTCAE (Common Terminology Criteria for Adverse Events) v3.0 criteria.Toxicity Criteria for Adverse Events version 3.0

Secondary Outcome Measures

Local Progression free survival

Disease-free survival

Defined as the time in month from all treatment were finished to the date of disease progress is observed.

Overall survival

Defined as the time in month from diagnosis of recurrent NPC to the date of death is observed or to last follow-up visit.

Full Information

NCT ID

NCT03666221

First Posted

September 10, 2018

Last Updated

September 10, 2018

Sponsor

Fujian Cancer Hospital

Collaborators

Sun Yat-sen University, Jiangxi Provincial Cancer Hospital, Zhejiang Cancer Hospital, Fujian Medical University Union Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03666221

Brief Title

Nimotuzumab for Recurrent Nasopharyngeal Carcinoma

Official Title

An Open,Multicenter,Phase II Trial of Intensity Modulated Radiation Therapy Combined With Concurrent Nimotuzumab in Patient With Recurrent Nasopharyngeal Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Unknown status

Study Start Date

November 1, 2014 (Actual)

Primary Completion Date

April 1, 2020 (Anticipated)

Study Completion Date

November 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fujian Cancer Hospital

Collaborators

Sun Yat-sen University, Jiangxi Provincial Cancer Hospital, Zhejiang Cancer Hospital, Fujian Medical University Union Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The study assessed the clinical efficacy, and safety of the combination of Nimotuzumab administered concomitantly with intensity modulated radiation therapy(IMRT) in patients with recurrent nasopharyngeal cancer.

Detailed Description

The clinical efficacy of Nimotuzumab combined with radiotherapy has been shown in advanced nasopharyngeal cancer, which was significantly higher than radiotherapy alone. The efficacy of radiotherapy combined with Nimotuzumab has not been confirmed in recurrent nasopharyngeal cancer.In this study, Phase II clinical trials were performed. The patients were treated with Nimotuzumab which were used concurrently with IMRT. The efficacy and toxicity will be assessed.

6. Conditions and Keywords

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

Recurrent Nasopharyngeal Carcinoma

Keywords

Nimotuzumab, IMRT, Radiation, Recurrent, Nasopharyngeal Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

67 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Nimotuzumab plus IMRT

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Nimotuzumab

Other Intervention Name(s)

Radiation

Intervention Description

Drug: Nimotuzumab Radiation: Intensity Modulated Radiation Therapy

Primary Outcome Measure Information:

Title

Tumor response rate after Nimotuzumab concurrent with radiotherapy for recurrent NPC patients

Description

Time Frame

Three month after patients subject to the treatment

Title

Toxicity of this combined treatment for recurrent NPC patients

Description

Adverse events of this combined modality treatment were graded according to CTCAE (Common Terminology Criteria for Adverse Events) v3.0 criteria.Toxicity Criteria for Adverse Events version 3.0

Time Frame

Three month after patients subject to the treatment

Secondary Outcome Measure Information:

Title

Local Progression free survival

Time Frame

Three years

Title

Disease-free survival

Description

Defined as the time in month from all treatment were finished to the date of disease progress is observed.

Time Frame

Three years

Title

Overall survival

Description

Defined as the time in month from diagnosis of recurrent NPC to the date of death is observed or to last follow-up visit.

Time Frame

Three 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: Patients with recurrent tumor in nasopharynx with or without relapse cervical lymph nodes more than 6 months after initial radical treatment. Recurrent nasopharyngeal cancer was confirmed by pathology, marginal recurrence can be diagnosed by imaging examinations. Age 18-70. At least one of the tumor lesions measurable. Functional Status: PS (ECOG) > 0-1. Normal Bone Marrow Function: White blood cell count > 4×109/L, hemoglobin >90g/L, and platelet count >100×109/L. Normal Hepatic and Renal Function: Alanine Tminotransferase (ALT)/Aspartate Aminotransferase (AST) < 2.5 times the upper limit of normal (ULN), while total bilirubin (T-Bil) < 1.5 x ULN and serum creatinine < 1.5 x ULN. Life expectancy of more than 6 months. All the patients signed the informed consent. Follow up regularly and comply with test requirements. Exclusion Criteria: Patients with recurrent cervical lymph nodes alone. Evidence of distant metastasis The relapse tumor has been treated with chemotherapy, radiotherapy, surgery, immunotherapy and other anti-tumor therapy. Creatinine clearance < 30ml/min Has received epidermal growth factor targeting therapy. Second malignancy within 5 years(except of Non-melanoma Skin Cancer or carcinoma in situ of cervix). Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc. Active systemic infection. History of Serious lung or heart disease. Drug or alcohol addiction. Persons without capacity for civil conduct or persons with limited capacity for civil conduct. The patient has physical or mental disorders and is believed to be unable to fully or fully understand the possible complications of the study. To receive chronic systemic immunotherapy or hormone therapy other than this study. Women who are pregnant or breast feeding Participation in other drugs clinical trials within 1 month.

Central Contact Person:

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

SHAOJUN LIN, Dr.

Phone

0591-62752225

linshaojun@yeah.net

Facility Information:

Facility Name

Department of radiation oncology, Fujian cancer hospital

City

Fuzhou

State/Province

Fujian

ZIP/Postal Code

350014

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

SHAOJUN LIN, master

Phone

0086-0591-62752225

linshaojun@yeah.net

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Nimotuzumab for Recurrent Nasopharyngeal Carcinoma

We'll reach out to this number within 24 hrs