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Chemoradiation Plus Weekly c225 Against Locoregionally Advanced Nasopharyngeal Carcinoma (NPC)

Primary Purpose

Nasopharyngeal Carcinoma

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Intensity-modulated radiotherapy

Concurrent chemotherapy with paclitaxel and nedaplatin

Cetuximab

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Locoregionally advanced nasopharyngeal carcinoma, cetuximab, chemoradiation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Pathologically confirmed untreated NPC patients
locoregionally advanced (T3-4 or N2-3 M0)
18-65 years
with MRI examinations
ECOG ≤ 2
With written consent

Exclusion Criteria:

Without a second cancer
Pregnancy
With other severe diseases (blood,liver ,kidney or heart diseases)
Could not be staged properly
Without written consent

Sites / Locations

Jiangsu Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

cetuximab

Arm Description

Patients will be given intensity-modulated radiotherapy,2 cycles of concurrent chemotherapy with paclitaxel and nedaplatin,and weekly cetuximab during radiation therapy.

Outcomes

Primary Outcome Measures

Number of Participants with Adverse Events as a Measure of Safety

Number of Participants with Adverse Events as a Measure of Safety and tolerability

Secondary Outcome Measures

Progress free survival

Full Information

NCT ID

NCT01712919

First Posted

October 18, 2012

Last Updated

March 21, 2014

Sponsor

Jiangsu Cancer Institute & Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01712919

Brief Title

Chemoradiation Plus Weekly c225 Against Locoregionally Advanced Nasopharyngeal Carcinoma (NPC)

Official Title

IMRT With Concurrent Chemotherapy and Cetuximab Against Locoregionally Advanced NPC: a Phase 1 Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

May 2010 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Jiangsu Cancer Institute & Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The investigators will add weekly cetuximab (c225) to the standard care of chemoradiation against locoregionally advanced Nasopharyngeal Carcinoma (NPC), and evaluate the toxicity and efficacy of this new regimen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Carcinoma

Keywords

Locoregionally advanced nasopharyngeal carcinoma, cetuximab, chemoradiation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

cetuximab

Arm Type

Experimental

Arm Description

Patients will be given intensity-modulated radiotherapy,2 cycles of concurrent chemotherapy with paclitaxel and nedaplatin,and weekly cetuximab during radiation therapy.

Intervention Type

Radiation

Intervention Name(s)

Intensity-modulated radiotherapy

Intervention Description

Patients will be given intensity-modulated radiotherapy(IMRT)

Intervention Type

Drug

Intervention Name(s)

Concurrent chemotherapy with paclitaxel and nedaplatin

Intervention Description

Patients will be given 2 cycles of concurrent chemotherapy with paclitaxel and nedaplatin

Intervention Type

Biological

Intervention Name(s)

Cetuximab

Intervention Description

Patients will be given cetuximab weekly during radiation therapy

Primary Outcome Measure Information:

Title

Number of Participants with Adverse Events as a Measure of Safety

Time Frame

6 months

Title

Number of Participants with Adverse Events as a Measure of Safety and tolerability

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Progress free survival

Time Frame

24 months

Other Pre-specified Outcome Measures:

Title

local-relapse free survival

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pathologically confirmed untreated NPC patients locoregionally advanced (T3-4 or N2-3 M0) 18-65 years with MRI examinations ECOG ≤ 2 With written consent Exclusion Criteria: Without a second cancer Pregnancy With other severe diseases (blood,liver ,kidney or heart diseases) Could not be staged properly Without written consent

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xia He, M.D. Ph.D.

Organizational Affiliation

Jiangsu Cancer Institute & Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jiangsu Cancer Hospital

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210009

Country

China

12. IPD Sharing Statement

Learn more about this trial

Chemoradiation Plus Weekly c225 Against Locoregionally Advanced Nasopharyngeal Carcinoma (NPC)

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