We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been terminated.
(slow patient enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01694576
First Posted: September 27, 2012
Last Update Posted: June 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Xia He, Jiangsu Cancer Institute & Hospital
  Purpose
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?

Condition Intervention Phase
Nasopharyngeal Carcinoma Drug: Adjuvant chemotherapy with paclitaxel and nedaplatin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adjuvant Chemotherapy or Not for NPC Patients Staged N2-3M0 After Concurrent Chemotherapy :a Phase Ⅱ Study

Resource links provided by NLM:


Further study details as provided by Dr. Xia He, Jiangsu Cancer Institute & Hospital:

Primary Outcome Measures:
  • treatment toxicity based on a CTCAE3.0 grading system [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • progress free survival [ Time Frame: 24 months ]

Other Outcome Measures:
  • distant metastasis free survival [ Time Frame: 24 months ]

Enrollment: 10
Study Start Date: September 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Adjuvant chemotherapy
No Intervention: Observation
Patients will be followed up without adjuvant chemotherapy 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?
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01694576


Locations
China, Jiangsu
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China, 210009
Sponsors and Collaborators
Jiangsu Cancer Institute & Hospital
Investigators
Principal Investigator: Xia He, M.D. and PhD Department of Radiotherapy,Jiangsu Cancer Hospital
  More Information

Responsible Party: Dr. Xia He, Director of the department of radiotherapy, Jiangsu Cancer Institute & Hospital
ClinicalTrials.gov Identifier: NCT01694576     History of Changes
Other Study ID Numbers: NPC-N23-RCT
JSCC-RCT01 ( Other Identifier: Department of Radiotherapy,Jiangsu Cancer Hospital )
First Submitted: September 17, 2012
First Posted: September 27, 2012
Last Update Posted: June 15, 2015
Last Verified: June 2015

Keywords provided by Dr. Xia He, Jiangsu Cancer Institute & Hospital:
Nasopharyngeal carcinoma staged N2-3M0
Adjuvant chemotherapy

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Paclitaxel
Nedaplatin
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action


To Top