Concurrent Nimotuzumab Versus Cisplatin With Radiotherapy for Locoregionally Advanced NPC

April 8, 2019 updated by: Lin Kong, Fudan University

Phase Ⅲ Study of Neoadjuvant TPF Chemotherapy Followed by Radiotherapy With Concurrent Nimotuzumab or Cisplatin for Locoregionally Advanced Nasopharyngeal Carcinoma (NPC).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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
Radiation: Radical radiotherapy
Drug: Concurrent nimotuzumab during radiotherapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
PFS
Time Frame: 3 years
3 years
OS
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Collaborators

The First Affiliated Hospital of Xiamen University
Fujian Province Tumor Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2012

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

August 1, 2017

Study Registration Dates

First Submitted

December 4, 2013

First Submitted That Met QC Criteria

December 10, 2013

First Posted (ESTIMATE)

December 16, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 10, 2019

Last Update Submitted That Met QC Criteria

April 8, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPC-IMRT-N

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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