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

This study has been terminated.
Sponsor:
Collaborator:
The Hong Kong Nasopharyngeal Cancer Study Group
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00563862
First received: November 21, 2007
Last updated: June 14, 2011
Last verified: June 2011
History of Changes
  Purpose

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


Condition Intervention
Nasopharyngeal Neoplasms
Carcinoma, Squamous Cell
 Procedure: Conventional RT
Procedure: Accelerated RT
Drug: Cisplatin
Drug: 5-fluorouracil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Hospital Authority, Hong Kong:

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

Secondary Outcome Measures:
  • Overall survival rate [ Time Frame: 5-year ]
  • Disease-specific survival rate [ Time Frame: 5-year ]
  • Complication-free rates [ Time Frame: 5-year ]

Enrollment: 465
Study Start Date: July 1999
Study Completion Date: June 2007
  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00563862

Locations
China
Pamela Youde Nethersole Eastern Hospital
Hong Kong, China
Queen Mary Hospital
Hong Kong, China
Queen Elizabeth Hospital
Hong Kong, China
Tuen Mun Hospital
Hong Kong, China
Prince of Wales Hospital
Hong Kong, China
Sponsors and Collaborators
Hospital Authority, Hong Kong
The Hong Kong Nasopharyngeal Cancer Study Group
Investigators
Principal Investigator: Anne WM Lee, Dr Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital
  More Information

Additional Information:
HAREC Clinical Trial Registry  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00563862     History of Changes
Other Study ID Numbers: L/M-78 to PYH 08/79, HARECCTR0500024, NPC99-02
Study First Received: November 21, 2007
Last Updated: June 14, 2011
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:
Nasopharyngeal Carcinoma
T3-4N0-1M0

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

ClinicalTrials.gov processed this record on May 22, 2013