Benefit of Adding Chemotherapy for Advance Nasopharyngeal Carcinoma (T1-4N2-3M0)

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. Identifier: NCT00563927
Recruitment Status : Unknown
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was:  Active, not recruiting
First Posted : November 26, 2007
Last Update Posted : July 7, 2010
Hong Kong Nasopharyngeal Cancer Study Group Limited
Information provided by:
Hospital Authority, Hong Kong

November 21, 2007
November 26, 2007
July 7, 2010
March 1999
Not Provided
Failure free survival rate [ Time Frame: 5 year ]
Same as current
Complete list of historical versions of study NCT00563927 on Archive Site
  • Disease-specific survival rate [ Time Frame: 5-year ]
  • Overall survival rate [ Time Frame: 5-year ]
  • Complication-free rates [ Time Frame: 5-year ]
Same as current
Not Provided
Not Provided
Benefit of Adding Chemotherapy for Advance Nasopharyngeal Carcinoma (T1-4N2-3M0)
Prospective Randomized Study on Therapeutic Gain Achieved By Addition of Chemotherapy for T1-4N2-3M0 Nasopharyngeal Carcinoma
To test the therapeutic ratio of additional chemotheray on advanced nasopharyngeal carcinoma.
Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Nasopharyngeal Neoplasms
  • Carcinoma, Squamous Cell
  • Procedure: Conventional RT
  • Drug: Cisplatin
  • Drug: 5-fluorouracil
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
October 2009
Not Provided

Inclusion Criteria:

  • Undifferentiated or non-keratinizing carcinoma
  • Tumor staged as N2-3
  • No evidence of distant metastasis M0
  • Performance status:0-2
  • Marrow: WBC >= 4 and platelet >= 100
  • Renal: creatinine clearance >= 60
  • Informed consent

Exclusion Criteria:

  • WHO type I squamous cell carcinoma or adenocarcinoma
  • Age >= 70
  • Palliative intent or tumor extent mandating AP opposing facio-cervical fields
  • Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years
  • Previous radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume
  • Previous chemotherapy
  • Patient is pregnant or lactating
Sexes Eligible for Study: All
up to 70 Years   (Child, Adult, Senior)
Not Provided
Contact information is only displayed when the study is recruiting subjects
L/M-77 TO PYH08/79
Not Provided
Not Provided
Not Provided
Not Provided
Hospital Authority, Hong Kong
Hong Kong Nasopharyngeal Cancer Study Group Limited
Principal Investigator: Wai Hon LAU, Dr Department of Clinical Oncology, Queen Elizabeth Hospital
Hospital Authority, Hong Kong
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP