Concurrent Nimotuzumab Versus Cisplatin With Radiotherapy for Locoregionally Advanced NPC

• ClinicalTrials.gov Identifier: NCT02012062
• Recruitment Status: Completed
• First Posted: December 16, 2013
• Last Update Posted: April 10, 2019
• Sponsor: Fudan University
• Collaborators: Fujian Province Tumor Hospital; The First Affiliated Hospital of Xiamen University
• Information provided by (Responsible Party): Lin Kong, Fudan University

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

More Information

• Responsible Party: Lin Kong, Dr., Fudan University
• ClinicalTrials.gov Identifier: NCT02012062
• Other Study ID Numbers: NPC-IMRT-N
• First Posted: December 16, 2013
• 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:

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; Cisplatin; Nimotuzumab; Antineoplastic Agents; Antineoplastic Agents, Immunological