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A Randomized Phase II Study of Concurrent Chemoradiation With Every 3 Week of Cisplatin vs With Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by Samsung Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01171781
First Posted: July 28, 2010
Last Update Posted: July 28, 2010
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:
Samsung Medical Center
  Purpose
The study try to show the weekly cisplatin based CCRT is not inferior to 3-weekly cisplabe based CCRT in terms of 3-yr progression free survival rate in advanced nasopharyngeal carcinoma

Condition Intervention Phase
Nasophayngeal Carcinoma Between Stage II and IVb Drug: cisplatin (3 weekly) Drug: cisplatin (weekly) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Concurrent Chemoradiation With Every 3 Week of Cisplatin vs With Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • progression free survival rate at 3 years [ Time Frame: 36 months ]

Secondary Outcome Measures:
  • overall survival rate [ Time Frame: 36 months ]
  • objective response rate [ Time Frame: 36 months ]
  • toxicity [ Time Frame: 36 months ]
  • quality of life [ Time Frame: 36 months ]

Estimated Enrollment: 110
Study Start Date: November 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 3 weekly CDDP based CCRT
radiation (conventioal or IMRT) with 3 cycles of 3-weekly cisplatin
Drug: cisplatin (3 weekly)
radiation with cisplatin (100mg/m2) on D1,D22,D43 and followed by adjuvant chemotherapy (3 cycles of FP)
Experimental: weekly cisplatin based CCRT
radiation (conventional or IMRT) with 7 cycles of weekly cisplatin therapy
Drug: cisplatin (weekly)
radiation with 7 cycles of cisplatin (40mg/m2) on D1,8,15,22,29,36,43, and followed by adjuvant chemothrapy (FP X3)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologically confirmed nasopharyngeal carcinoma age of 18 years or over stage II ~ IVb no history of chemotherapy, radiotherapy, or immunotherapy for NPC with measurable lesion based on RECIST 1.1 ECOG PS 0 ~2 good organ function (liver, renal, hematologic)

Exclusion Criteria:

  • active infectious disease requiring antibiotics uncontrolled heart disease pregnancy and on feeding state history of other malignancy within 5 years before enrollment, except for well treated non-melanomatous skin cancer, in situ cervical cancer, thyroid cancer
  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): NCT01171781


Contacts
Contact: Myung-Ju Ahn, M.D, Ph.D. 822-3410-3438 silkahn@skku.edu

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Myung-Ju Ahn, M.D., Ph.D.    822-3410-3438    silkahn@skku.edu   
Principal Investigator: Myung-Ju Ahn, M.D., Ph.D.         
Sponsors and Collaborators
Samsung Medical Center
  More Information

Responsible Party: Myung-Ju Ahn, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01171781     History of Changes
Other Study ID Numbers: 2009-09-037
First Submitted: July 27, 2010
First Posted: July 28, 2010
Last Update Posted: July 28, 2010
Last Verified: July 2010

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
Cisplatin
Antineoplastic Agents