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Concurrent Nimotuzumab Versus Cisplatin With Radiotherapy for Locoregionally Advanced NPC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02012062
Recruitment Status : Completed
First Posted : December 16, 2013
Last Update Posted : April 10, 2019
Sponsor:
Collaborators:
Fujian Province Tumor Hospital
The First Affiliated Hospital of Xiamen University
Information provided by (Responsible Party):
Lin Kong, Fudan University

Brief Summary:
The study is to evaluate whether concurrent nimotuzumab could decrease the severe acute treatment-related toxicities compared with concurrent chemoradiotherapy for locoregionally advanced NPC. Three hundreds and twenty patients will be recruited into this study.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: TPF neoadjuvant chemotherapy Drug: Concurrent chemotherapy with cisplatin during radiotherapy Drug: Concurrent nimotuzumab during radiotherapy Radiation: Radical radiotherapy Phase 3

Detailed Description:

Scheme:

Eligible stage III and IVA/B NPC patients will first be stratified by institution, then randomized to 2 arms at 1:1 ratio.

- Arm Cisplatin:

Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by cisplatin 40 mg/m2/week in concurrent with IMRT

- Arm nimotuzumab:

Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by weekly nimotuzumab 200mg in concurrent with IMRT

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Ⅲ Study of Neoadjuvant TPF Chemotherapy Followed by Radiotherapy With Concurrent Nimotuzumab or Cisplatin for Locoregionally Advanced Nasopharyngeal Carcinoma (NPC).
Actual Study Start Date : July 2012
Actual Primary Completion Date : March 2016
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Arm Intervention/treatment
Active Comparator: Arm Cisplatin
Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by cisplatin 40 mg/m2/week in concurrent with IMRT
Drug: TPF neoadjuvant chemotherapy
Drug: Concurrent chemotherapy with cisplatin during radiotherapy
Radiation: Radical radiotherapy
Experimental: Arm Nimotuzumab
Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by weekly nimotuzumab 200mg in concurrent with IMRT
Drug: TPF neoadjuvant chemotherapy
Drug: Concurrent nimotuzumab during radiotherapy
Radiation: Radical radiotherapy



Primary Outcome Measures :
  1. Number of Participants with Adverse Events (severe radiation-induced skin and mucosal toxicities) [ Time Frame: From Day 1 to Day 90 of radiotherapy ]

Secondary Outcome Measures :
  1. PFS [ Time Frame: 3 years ]
  2. OS [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven poorly differentiated or undifferentiated carcinoma of the nasopharynx.
  • Stage III and IVA/B NPC patients
  • KPS >70
  • Age between 18-70
  • AGC > 2000, platelets > 100,000, AST or ALT<2 x upper normal, serum creatinine<1.5mg/dl, creatinine clearance >50ml/min

Exclusion Criteria:

  • Histology other than poorly differentiated or undifferentiated carcinoma, including keratinized squamous cell carcinoma.
  • Evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations.
  • Initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease.
  • Patients with simultaneous or prior malignancy (not include basal cell carcinoma of skin)
  • Prior radiation treatment to the head and neck or any prior chemotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02012062


Locations
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China
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Fujian Province Tumor Hospital
The First Affiliated Hospital of Xiamen University
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Responsible Party: Lin Kong, Dr., Fudan University
ClinicalTrials.gov Identifier: NCT02012062    
Other Study ID Numbers: NPC-IMRT-N
First Posted: December 16, 2013    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Keywords provided by Lin Kong, Fudan University:
Nasopharyngeal carcinoma
Neoadjuvant chemotherapy
Concurrent chemotherapy
Nimotuzumab
Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal 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
Nimotuzumab
Antineoplastic Agents
Antineoplastic Agents, Immunological