Benefit of Adding Chemotherapy And/Or Modification of Radiotherapy Schedule for Advance Nasopharyngeal Carcinoma (T3-4N0-1M0)

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: NCT00563862
Recruitment Status : Terminated
First Posted : November 26, 2007
Last Update Posted : June 16, 2011
The Hong Kong Nasopharyngeal Cancer Study Group
Information provided by:
Hospital Authority, Hong Kong

Brief Summary:
To test the therapeutic ratio of accelerated radiotherapy and/or chemotherapy on locally advanced nasopharyngeal carcinoma.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 465 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Study on Therapeutic Gain Achieved By Chemoradiation And/Or Accelerated Radiation For T3-4N0-1M0 Nasopharyngeal Carcinoma
Study Start Date : July 1999
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Undifferentiated or non-keratinizing carcinoma
  • Tumor staged as T3-4 AND N0-1
  • 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 identifier (NCT number): NCT00563862

Pamela Youde Nethersole Eastern Hospital
Hong Kong, China
Prince of Wales 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
The Hong Kong Nasopharyngeal Cancer Study Group
Principal Investigator: Anne WM Lee, Dr Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital

Additional Information: Identifier: NCT00563862     History of Changes
Other Study ID Numbers: L/M-78 to PYH 08/79
First Posted: November 26, 2007    Key Record Dates
Last Update Posted: June 16, 2011
Last Verified: June 2011

Keywords provided by Hospital Authority, Hong Kong:
Nasopharyngeal Carcinoma

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