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

June 12, 2015 updated by: Dr. Xia He, Jiangsu Cancer Institute & Hospital

Adjuvant Chemotherapy or Not for NPC Patients Staged N2-3M0 After Concurrent Chemotherapy :a Phase Ⅱ Study

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?

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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?

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

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
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Jiangsu Cancer Hospital

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adjuvant chemotherapy with paclitaxel and nedaplatin
Patients will receive 3 cycles of adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation
Drug: Adjuvant chemotherapy with paclitaxel and nedaplatin
Patients receive 3 cycles of adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation
Other Names:
  • Adjuvant chemotherapy
No Intervention: Observation
Patients will be followed up without adjuvant chemotherapy after concurrent chemoradiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
treatment toxicity based on a CTCAE3.0 grading system
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
progress free survival
Time Frame: 24 months
24 months

Other Outcome Measures

Outcome Measure
Time Frame
distant metastasis free survival
Time Frame: 24 months
24 months

Collaborators and Investigators

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

Sponsor

Jiangsu Cancer Institute & Hospital

Investigators

  • Principal Investigator: Xia He, M.D. and PhD, Department of Radiotherapy,Jiangsu Cancer 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

September 1, 2012

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

September 17, 2012

First Submitted That Met QC Criteria

September 26, 2012

First Posted (Estimate)

September 27, 2012

Study Record Updates

Last Update Posted (Estimate)

June 15, 2015

Last Update Submitted That Met QC Criteria

June 12, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPC-N23-RCT
  • JSCC-RCT01 (Other Identifier: Department of Radiotherapy,Jiangsu Cancer Hospital)

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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