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

This study has been terminated.

Sponsors and Collaborators:	Hospital Authority, Hong Kong The Hong Kong Nasopharyngeal Cancer Study Group
Information provided by:	Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:	NCT00563862

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

MedlinePlus related topics: Cancer

Drug Information available for: Cisplatin Fluorouracil Liothyronine sodium Triiodothyronine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Official Title:	Prospective Randomized Study on Therapeutic Gain Achieved By Chemoradiation And/Or Accelerated Radiation For T3-4N0-1M0 Nasopharyngeal Carcinoma

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

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

Study ID Numbers:	L/M-78 to PYH 08/79, HARECCTR0500024, NPC99-02
Study First Received:	November 21, 2007
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00563862
Health Authority:	Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:

Nasopharyngeal Carcinoma
T3-4N0-1M0

Study placed in the following topic categories:

Otorhinolaryngologic Neoplasms
Otorhinolaryngologic Diseases
Pharyngeal Neoplasms
Pharyngeal Diseases
Nasopharyngeal Neoplasms
Carcinoma
Nasopharyngeal carcinoma
Cisplatin

Fluorouracil
Head and Neck Neoplasms
Carcinoma, squamous cell
Neoplasms, Squamous Cell
Stomatognathic Diseases
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs

Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Nasopharyngeal Diseases

ClinicalTrials.gov processed this record on January 14, 2009