Concurrent Nimotuzumab Versus Cisplatin With Radiotherapy for Locoregionally Advanced NPC

NCT02012062 | Completed Phase 3 DMC

• 1 other identifier: NPC-IMRT-N
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal carcinoma; Neoadjuvant chemotherapy; Concurrent chemotherapy; Nimotuzumab

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events (severe radiation-induced skin and mucosal toxicities)

  From Day 1 to Day 90 of radiotherapy

Secondary Outcomes (2)

• PFS

  3 years

• OS

  3 years

Study Arms (2)

Arm Cisplatin

ACTIVE COMPARATOR

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

Arm Nimotuzumab

EXPERIMENTAL

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

Interventions

TPF neoadjuvant chemotherapy DRUG

Arm Cisplatin; Arm Nimotuzumab

Concurrent chemotherapy with cisplatin during radiotherapy DRUG

Arm Cisplatin

Concurrent nimotuzumab during radiotherapy DRUG

Arm Nimotuzumab

Radical radiotherapy RADIATION

Arm Cisplatin; Arm Nimotuzumab

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead
• Fujian Province Tumor Hospital: collaborator
• The First Affiliated Hospital of Xiamen University: collaborator

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 16, 2013
• Study Start: July 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: August 1, 2017
• Last Updated: April 10, 2019

Record last verified: 2019-04

Locations

CN (1)