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Benefit of Changing Chemoradiotherapy Sequence and Modifying Radiotherapy Schedule for Advanced Nasopharyngeal Cancer

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ClinicalTrials.gov Identifier: NCT00577057
Recruitment Status : Unknown
Verified August 2013 by Hospital Authority, Hong Kong.
Recruitment status was:  Not yet recruiting
First Posted : December 19, 2007
Last Update Posted : August 22, 2013
Hong Kong Nasopharyngeal Cancer Study Group Limited
Information provided by:
Hospital Authority, Hong Kong

Brief Summary:

The objectives of this clinical study are threefold:

  1. To compare the benefits in cancer control and survival obtained from adding induction-concurrent chemotherapy to radiation with those from adding concurrent-adjuvant chemotherapy to radiation.
  2. To test whether replacing fluorouracil with Xeloda in combining with cisplatin (PF or PX, respectively) in the chemotherapy plan will maintain or improve further the chemotherapy benefits while reducing the duration of hospital stay.
  3. To see if accelerated fractionation radiotherapy can improve the outcome of patients as compared with conventional fractionation radiotherapy.

Condition or disease Intervention/treatment
Nasopharyngeal Neoplasms Procedure: Conventional Radiotherapy Procedure: Accelerated Radiotherapy Drug: Cisplatin Drug: 5-fluorouracil Drug: Capecitabine

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 798 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial to Evaluate the Therapeutic Gain by Changing the Chemoradiotherapy From Concurrent-adjuvant to Induction-concurrent Sequence, and the Radiotherapy From Conventional to Accelerated Fractionation for Advanced Nasopharyngeal Carcinoma
Study Start Date : September 2006
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 5-year ]
  2. Overall Survival [ Time Frame: 5-year ]

Secondary Outcome Measures :
  1. Overall / Locoregional / Distant Failure Free Rate [ Time Frame: 5-year ]
  2. Chemotherapy and RT toxicity [ Time Frame: within 90 day from commencement of RT ]
  3. Late Toxicity [ Time Frame: 5-year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Histologically proven nasopharyngeal carcinoma
  • Non-keratinizing or undifferentiated type Stage III-IVB (by AJCC/UICC 6th edition)
  • Essential staging investigations: CT or MRI of nasopharyngeal region Chest x-ray (or CT thorax)
  • Liver function test, alkaline phosphatase Liver and bone scan if alkaline phosphatase exceeds the institutional upper limit of normal, or if clinically indicated.
  • Liver scan if SGOT exceeds the institutional upper limit of normal
  • Adequate marrow: WBC > 4 and platelet > 100
  • Adequate renal function: creatinine clearance > 60 ml/min.
  • Satisfactory performance status: > 2 by ECOG System.

Exclusion Criteria:

  • WHO Type I squamous cell carcinoma or adenocarcinoma
  • Age > 70
  • Treatment with palliative intent (including those with tumor extent mandating the use of AP opposing facio-cervical field technique)
  • 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 five years.
  • Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
  • History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume).
  • Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00577057

Contact: Anne WM Lee, Cos (852) 2595 4173 awmlee@ha.org.hk

Pamela Youde Nethersole Eastern Hospital Not yet recruiting
Hong Kong, China
Prince of Wales Hospital Not yet recruiting
Hong Kong, China
Princess Margaret Hospital Not yet recruiting
Hong Kong, China
Sub-Investigator: Ashley Cheng, Dr         
Queen Elizabeth Hospital Not yet recruiting
Hong Kong, China
Sub-Investigator: Roger Ngan, Dr         
Queen Mary Hospital Not yet recruiting
Hong Kong, China
Sub-Investigator: Dora Kwong, Dr         
Tuen Mun Hospital Not yet recruiting
Hong Kong, China
Sub-Investigator: Stewart Y Tung, Dr         
Sponsors and Collaborators
Hospital Authority, Hong Kong
Hong Kong Nasopharyngeal Cancer Study Group Limited
Principal Investigator: Anne WM Lee, Cos Clinical Oncology, Pamela Youde Nethersole Eastern Hospital

Additional Information:
ClinicalTrials.gov Identifier: NCT00577057     History of Changes
Other Study ID Numbers: HKEC-2006-120
First Posted: December 19, 2007    Key Record Dates
Last Update Posted: August 22, 2013
Last Verified: August 2013

Keywords provided by Hospital Authority, Hong Kong:
Nasopharyngeal Carcinoma
Stage III - IVB

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs