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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Jiangsu Cancer Institute & Hospital
Sponsor:
Information provided by (Responsible Party):
Dr. Xia He, Jiangsu Cancer Institute & Hospital
ClinicalTrials.gov Identifier:
NCT01694576
First received: September 17, 2012
Last updated: March 21, 2014
Last verified: March 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Jiangsu Cancer Institute & Hospital:

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

Secondary Outcome Measures:
  • progress free survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • distant metastasis free survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: September 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01694576

Contacts
Contact: Jianhua Xu, M.D. 15805161106 xu016@sohu.com

Locations
China, Jiangsu
Jiangsu Cancer Hospital Recruiting
Nanjing, Jiangsu, China, 210009
Contact: Jianhua Xu, M.D.    15805161106    xu016@sohu.com   
Sub-Investigator: Jianhua Xu, M.D.         
Sponsors and Collaborators
Jiangsu Cancer Institute & Hospital
Investigators
Principal Investigator: Xia He, M.D. and PhD Department of Radiotherapy,Jiangsu Cancer Hospital
  More Information

No publications provided

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
Study First Received: September 17, 2012
Last Updated: March 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Jiangsu Cancer Institute & Hospital:
Nasopharyngeal carcinoma staged N2-3M0
Adjuvant chemotherapy

Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Nedaplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2014