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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00563927
Enrollment
340
Registered
2007-11-26
Start date
1999-03-31
Completion date
2009-10-31
Last updated
2010-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Squamous Cell, Nasopharyngeal Neoplasms

Keywords

Nasopharyngeal Carcinoma, T1-4N2-3M0

Brief summary

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

Interventions

DRUGCisplatin
DRUG5-fluorouracil

Sponsors

Hong Kong Nasopharyngeal Cancer Study Group Limited
CollaboratorOTHER
Hospital Authority, Hong Kong
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 70 Years

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

Design outcomes

Primary

MeasureTime frame
Failure free survival rate5 year

Secondary

MeasureTime frame
Disease-specific survival rate5-year
Overall survival rate5-year
Complication-free rates5-year

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026