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

Verified by: Hospital Authority, Hong Kong, June 2011
First Received: November 21, 2007 | Last Updated: June 14, 2011 | Phase: N/A | Start Date: July 1999
Overall Status: Terminated | Estimated Enrollment: 465
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To test the therapeutic ratio of accelerated radiotherapy and/or chemotherapy on locally advanced nasopharyngeal carcinoma...

Brief Summary

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

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

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Intervention(s) in this Clinical Trial

  • Procedure: Conventional RT
  • Procedure: Accelerated RT
  • Drug: Cisplatin
  • Drug: 5-fluorouracil

Outcome Measures for this Clinical Trial

Primary Measures

  • Failure free survival rate
    • Time Frame: 5-year

Secondary Measures

  • Overall survival rate
    • Time Frame: 5-year
  • Disease-specific survival rate
    • Time Frame: 5-year
  • Complication-free rates
    • Time Frame: 5-year

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 70 Years

Clinical Trial Investigator Information

Lead Investigator: Hospital Authority, Hong Kong Other

Overall Clinical Trial Officials and Contacts

Anne WM Lee, Dr Principal Investigator Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00563862

Study ID Number: L/M-78 to PYH 08/79

ClinicalTrials.gov Identifier: NCT00563862

Health Authority: Hong Kong: Ethics Committee

HAREC Clinical Trial Registry

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