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Clinical Trials/NCT00563862
NCT00563862
Terminated
Not Applicable

Prospective Randomized Study on Therapeutic Gain Achieved By Chemoradiation And/Or Accelerated Radiation For T3-4N0-1M0 Nasopharyngeal Carcinoma

Hospital Authority, Hong Kong5 sites in 1 country465 target enrollmentJuly 1999
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ConditionsNasopharyngeal NeoplasmsCarcinoma, Squamous Cell
DrugsCisplatin5-fluorouracil

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nasopharyngeal Neoplasms
Sponsor
Hospital Authority, Hong Kong
Enrollment
465
Locations
5
Primary Endpoint
Failure free survival rate
Status
Terminated
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
July 1999
End Date
June 2007
Last Updated
14 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Sponsor
Hospital Authority, Hong Kong

Eligibility 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

Outcomes

Primary Outcomes

Failure free survival rate

Time Frame: 5-year

Secondary Outcomes

  • Overall survival rate(5-year)
  • Disease-specific survival rate(5-year)
  • Complication-free rates(5-year)

Study Sites (5)

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