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

Not Applicable

Terminated

• Conditions: Nasopharyngeal Neoplasms; Carcinoma, Squamous Cell

• Registration Number: NCT00563862
• Lead Sponsor: Hospital Authority, Hong Kong

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 1999-07
• Study Completion: 2007-06
• Study First Submitted: 2007-11-21
• Study First Submitted QC: 2007-11-23
• Study First Posted: 2007-11-26
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-14
• Last Update Posted: 2011-06-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 465

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Failure free survival rate	5-year

Secondary Outcome Measures

Name	Time	Method
Overall survival rate	5-year
Disease-specific survival rate	5-year
Complication-free rates	5-year

Trial Locations

Locations (5)

Queen Mary Hospital; 🇨🇳 Hong Kong, China

Prince of Wales Hospital; 🇨🇳 Hong Kong, China

Tuen Mun Hospital; 🇨🇳 Hong Kong, China

Pamela Youde Nethersole Eastern Hospital; 🇨🇳 Hong Kong, China

Queen Elizabeth Hospital; 🇨🇳 Hong Kong, China