search
Back to results

Concurrent Nimotuzumab Versus Cisplatin With Radiotherapy for Locoregionally Advanced NPC

Primary Purpose

Nasopharyngeal Carcinoma

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
TPF neoadjuvant chemotherapy
Concurrent chemotherapy with cisplatin during radiotherapy
Concurrent nimotuzumab during radiotherapy
Radical radiotherapy
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal carcinoma, Neoadjuvant chemotherapy, Concurrent chemotherapy, Nimotuzumab

Eligibility Criteria

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

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

Sites / Locations

  • Fudan University Shanghai Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm Cisplatin

Arm Nimotuzumab

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

PFS
OS

Full Information

First Posted
December 4, 2013
Last Updated
April 8, 2019
Sponsor
Fudan University
Collaborators
Fujian Province Tumor Hospital, The First Affiliated Hospital of Xiamen University
search

1. Study Identification

Unique Protocol Identification Number
NCT02012062
Brief Title
Concurrent Nimotuzumab Versus Cisplatin With Radiotherapy for Locoregionally Advanced NPC
Official Title
Phase Ⅲ Study of Neoadjuvant TPF Chemotherapy Followed by Radiotherapy With Concurrent Nimotuzumab or Cisplatin for Locoregionally Advanced Nasopharyngeal Carcinoma (NPC).
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 2012 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
Collaborators
Fujian Province Tumor Hospital, The First Affiliated Hospital of Xiamen University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
Nasopharyngeal carcinoma, Neoadjuvant chemotherapy, Concurrent chemotherapy, Nimotuzumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm Cisplatin
Arm Type
Active Comparator
Arm Description
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 Title
Arm Nimotuzumab
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
TPF neoadjuvant chemotherapy
Intervention Type
Drug
Intervention Name(s)
Concurrent chemotherapy with cisplatin during radiotherapy
Intervention Type
Drug
Intervention Name(s)
Concurrent nimotuzumab during radiotherapy
Intervention Type
Radiation
Intervention Name(s)
Radical radiotherapy
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
PFS
Time Frame
3 years
Title
OS
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Learn more about this trial

Concurrent Nimotuzumab Versus Cisplatin With Radiotherapy for Locoregionally Advanced NPC

We'll reach out to this number within 24 hrs