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NPC Staged N2-3M0:Adjuvant Chemotherapy or Just Observation After Concurrent Chemoradiation

Primary Purpose

Nasopharyngeal Carcinoma

Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Adjuvant chemotherapy with paclitaxel and nedaplatin
Sponsored by
Jiangsu Cancer Institute & Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal carcinoma staged N2-3M0, Adjuvant chemotherapy

Eligibility Criteria

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

Inclusion Criteria:

  1. pathologically confirmed untreated NPC patients staged N2-3M0
  2. age: 18y - 65y
  3. with MRI examinations
  4. ECOG≤2
  5. with written consent

Exclusion Criteria:

  1. without a second cancer
  2. pregnancy
  3. with other severe diseases(blood,liver ,kidney or heart diseases)
  4. could not staged properly
  5. without written consent

Sites / Locations

  • Jiangsu Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Adjuvant chemotherapy with paclitaxel and nedaplatin

Observation

Arm Description

Patients will receive 3 cycles of adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation

Patients will be followed up without adjuvant chemotherapy after concurrent chemoradiation

Outcomes

Primary Outcome Measures

treatment toxicity based on a CTCAE3.0 grading system

Secondary Outcome Measures

progress free survival

Full Information

First Posted
September 17, 2012
Last Updated
June 12, 2015
Sponsor
Jiangsu Cancer Institute & Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01694576
Brief Title
NPC Staged N2-3M0:Adjuvant Chemotherapy or Just Observation After Concurrent Chemoradiation
Official Title
Adjuvant Chemotherapy or Not for NPC Patients Staged N2-3M0 After Concurrent Chemotherapy :a Phase Ⅱ Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
slow patient enrollment
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)

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
By this clinical trial, the investigators are trying to give an answer to such a question. Whether NPC patients staged N2-3M0 need adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation?
Detailed Description
Recent research (Lancet Oncology 2012)shows that no survival benefits were achieved by adding adjuvant chemotherapy after concurrent chemoradiation in patients with locoregionally advanced NPC. But in patients with even high risk of distant metastasis(staged N2-3M0),is adjuvant chemotherapy necessary?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
Nasopharyngeal carcinoma staged N2-3M0, Adjuvant chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adjuvant chemotherapy with paclitaxel and nedaplatin
Arm Type
Experimental
Arm Description
Patients will receive 3 cycles of adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation
Arm Title
Observation
Arm Type
No Intervention
Arm Description
Patients will be followed up without adjuvant chemotherapy after concurrent chemoradiation
Intervention Type
Drug
Intervention Name(s)
Adjuvant chemotherapy with paclitaxel and nedaplatin
Other Intervention Name(s)
Adjuvant chemotherapy
Intervention Description
Patients receive 3 cycles of adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation
Primary Outcome Measure Information:
Title
treatment toxicity based on a CTCAE3.0 grading system
Time Frame
6 months
Secondary Outcome Measure Information:
Title
progress free survival
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
distant metastasis 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
No
Eligibility Criteria
Inclusion Criteria: pathologically confirmed untreated NPC patients staged N2-3M0 age: 18y - 65y 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 staged properly without written consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xia He, M.D. and PhD
Organizational Affiliation
Department of Radiotherapy,Jiangsu Cancer 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

NPC Staged N2-3M0:Adjuvant Chemotherapy or Just Observation After Concurrent Chemoradiation

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