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NCT00563927 Clinical Trial

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

Carcinoma, Squamous Cell Clinical Trial

Official title:
Prospective Randomized Study on Therapeutic Gain Achieved By Addition of Chemotherapy for T1-4N2-3M0 Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00563927
Other study ID # L/M-77 TO PYH08/79
Secondary ID HARECCTR0500023N
Status Active, not recruiting
Phase N/A
First received November 21, 2007
Last updated July 6, 2010
Start date March 1999
Est. completion date October 2009

Study information
Verified date July 2010
Source Hospital Authority, Hong Kong
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 340
Est. completion date October 2009
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group N/A to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Conventional RT

Drug:
• Cisplatin

• 5-fluorouracil

Locations
Country Name City State
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

Sponsors (2)
Lead Sponsor Collaborator
Hospital Authority, Hong Kong Hong Kong Nasopharyngeal Cancer Study Group Limited

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Failure free survival rate 5 year
Secondary Disease-specific survival rate 5-year
Secondary Overall survival rate 5-year
Secondary Complication-free rates 5-year
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