Nimotuzumab for Recurrent Nasopharyngeal Carcinoma

NCT03666221 | Unknown Phase 2

• 1 other identifier: NPC001.2
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Nasopharyngeal Carcinoma

Keywords

Nimotuzumab; IMRT; Radiation; Recurrent; Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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.

  Three month after patients subject to the treatment

• 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

  Three month after patients subject to the treatment

Secondary Outcomes (3)

• Local Progression free survival

  Three years

• Disease-free survival

  Three years

• Overall survival

  Three years

Study Arms (1)

Nimotuzumab plus IMRT

EXPERIMENTAL

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.

Drug: Nimotuzumab

Interventions

Nimotuzumab DRUG

Drug: Nimotuzumab Radiation: Intensity Modulated Radiation Therapy

Also known as: Radiation

Nimotuzumab plus IMRT

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead
• Sun Yat-sen University: collaborator
• Jiangxi Provincial Cancer Hospital: collaborator
• Zhejiang Cancer Hospital: collaborator
• Fujian Medical University Union Hospital: collaborator

Study Sites (1)

Department of radiation oncology, Fujian cancer hospital

Fuzhou, Fujian, 350014, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Recurrence

Interventions

nimotuzumab; Radiation

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Phenomena

Central Study Contacts

SHAOJUN LIN, Dr.

CONTACT

0591-62752225; linshaojun@yeah.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 11, 2018
• Study Start: November 1, 2014
• Primary Completion: April 1, 2020
• Study Completion: November 1, 2022
• Last Updated: September 11, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)