Benefit of Changing Chemoradiotherapy Sequence and Modifying Radiotherapy Schedule for Advanced Nasopharyngeal Cancer
NCT ID: NCT00577057
Last Updated: 2013-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
798 participants
INTERVENTIONAL
2006-09-30
2013-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Interventions
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Conventional Radiotherapy
Accelerated Radiotherapy
Cisplatin
5-fluorouracil
Capecitabine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Hong Kong Nasopharyngeal Cancer Study Group Limited
OTHER
Hospital Authority, Hong Kong
OTHER_GOV
Principal Investigators
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Anne WM Lee, Cos
Role: PRINCIPAL_INVESTIGATOR
Clinical Oncology, Pamela Youde Nethersole Eastern Hospital
Locations
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Pamela Youde Nethersole Eastern Hospital
Hong Kong, , China
Prince of Wales Hospital
Hong Kong, , China
Princess Margaret Hospital
Hong Kong, , China
Queen Elizabeth Hospital
Hong Kong, , China
Queen Mary Hospital
Hong Kong, , China
Tuen Mun Hospital
Hong Kong, , China
Countries
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Central Contacts
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Other Identifiers
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HARECCTR0500062
Identifier Type: -
Identifier Source: secondary_id
NPC-0501
Identifier Type: -
Identifier Source: secondary_id
HKEC-2006-120
Identifier Type: -
Identifier Source: org_study_id