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

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
Hong Kong Nasopharyngeal Cancer Study Group Limited
Information provided by:
Hospital Authority, Hong Kong

Brief Summary:
To test the therapeutic ratio of additional chemotheray on advanced nasopharyngeal carcinoma.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Neoplasms Carcinoma, Squamous Cell Procedure: Conventional RT Drug: Cisplatin Drug: 5-fluorouracil Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Study on Therapeutic Gain Achieved By Addition of Chemotherapy for T1-4N2-3M0 Nasopharyngeal Carcinoma
Study Start Date : March 1999
Estimated Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Failure free survival rate [ Time Frame: 5 year ]

Secondary Outcome Measures :
  1. Disease-specific survival rate [ Time Frame: 5-year ]
  2. Overall survival rate [ Time Frame: 5-year ]
  3. Complication-free rates [ Time Frame: 5-year ]


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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Criteria

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

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): NCT00563927


Locations
China
Pamela Youde Nethersole Eastern Hospital
Hong Kong, China
Queen Elizabeth Hospital
Hong Kong, China
Queen Mary Hospital
Hong Kong, China
Tuen Mun Hospital
Hong Kong, China
Sponsors and Collaborators
Hospital Authority, Hong Kong
Hong Kong Nasopharyngeal Cancer Study Group Limited
Investigators
Principal Investigator: Wai Hon LAU, Dr Department of Clinical Oncology, Queen Elizabeth Hospital

Additional Information:
ClinicalTrials.gov Identifier: NCT00563927     History of Changes
Other Study ID Numbers: L/M-77 TO PYH08/79
HARECCTR0500023
NPC99-01
First Posted: November 26, 2007    Key Record Dates
Last Update Posted: July 7, 2010
Last Verified: July 2010

Keywords provided by Hospital Authority, Hong Kong:
Nasopharyngeal Carcinoma
T1-4N2-3M0

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Neoplasms, Squamous Cell
Carcinoma
Carcinoma, Squamous Cell
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Fluorouracil
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs