Overview

This trial is active, not recruiting.

Conditions nasopharyngeal neoplasms, carcinoma, squamous cell
Treatments conventional rt, cisplatin, 5-fluorouracil
Sponsor Hospital Authority, Hong Kong
Collaborator Hong Kong Nasopharyngeal Cancer Study Group Limited
Start date March 1999
End date October 2009
Trial size 340 participants
Trial identifier NCT00563927, HARECCTR0500023, L/M-77 TO PYH08/79, NPC99-01

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Failure free survival rate
time frame: 5 year

Secondary Outcomes

Measure
Disease-specific survival rate
time frame: 5-year
Overall survival rate
time frame: 5-year
Complication-free rates
time frame: 5-year

Eligibility Criteria

Male or female participants up to 70 years old.

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

Additional Information

Official title Prospective Randomized Study on Therapeutic Gain Achieved By Addition of Chemotherapy for T1-4N2-3M0 Nasopharyngeal Carcinoma
Principal investigator Wai Hon LAU, Dr
Trial information was received from ClinicalTrials.gov and was last updated in July 2010.
Information provided to ClinicalTrials.gov by Hospital Authority, Hong Kong.