Benefit of Changing Chemoradiotherapy Sequence and Modifying Radiotherapy Schedule for Advanced Nasopharyngeal Cancer
Primary Purpose
Nasopharyngeal Neoplasms
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Conventional Radiotherapy
Accelerated Radiotherapy
Cisplatin
5-fluorouracil
Capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Neoplasms focused on measuring Nasopharyngeal Carcinoma, Stage III - IVB
Eligibility Criteria
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.
Sites / Locations
- Pamela Youde Nethersole Eastern Hospital
- Prince of Wales Hospital
- Princess Margaret Hospital
- Queen Elizabeth Hospital
- Queen Mary Hospital
- Tuen Mun Hospital
Outcomes
Primary Outcome Measures
Progression-free survival
Overall Survival
Secondary Outcome Measures
Overall / Locoregional / Distant Failure Free Rate
Chemotherapy and RT toxicity
Late Toxicity
Full Information
NCT ID
NCT00577057
First Posted
December 18, 2007
Last Updated
August 21, 2013
Sponsor
Hospital Authority, Hong Kong
Collaborators
Hong Kong Nasopharyngeal Cancer Study Group Limited
1. Study Identification
Unique Protocol Identification Number
NCT00577057
Brief Title
Benefit of Changing Chemoradiotherapy Sequence and Modifying Radiotherapy Schedule for Advanced Nasopharyngeal Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Authority, Hong Kong
Collaborators
Hong Kong Nasopharyngeal Cancer Study Group Limited
4. Oversight
5. Study Description
Brief Summary
The objectives of this clinical study are threefold:
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.
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.
To see if accelerated fractionation radiotherapy can improve the outcome of patients as compared with conventional fractionation radiotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Neoplasms
Keywords
Nasopharyngeal Carcinoma, Stage III - IVB
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
798 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Conventional Radiotherapy
Intervention Type
Procedure
Intervention Name(s)
Accelerated Radiotherapy
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
5-year
Title
Overall Survival
Time Frame
5-year
Secondary Outcome Measure Information:
Title
Overall / Locoregional / Distant Failure Free Rate
Time Frame
5-year
Title
Chemotherapy and RT toxicity
Time Frame
within 90 day from commencement of RT
Title
Late Toxicity
Time Frame
5-year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne WM Lee, Cos
Phone
(852) 2595 4173
Email
awmlee@ha.org.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne WM Lee, Cos
Organizational Affiliation
Clinical Oncology, Pamela Youde Nethersole Eastern Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamela Youde Nethersole Eastern Hospital
City
Hong Kong
Country
China
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
China
Facility Name
Princess Margaret Hospital
City
Hong Kong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Cheng, Dr
Facility Name
Queen Elizabeth Hospital
City
Hong Kong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roger Ngan, Dr
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dora Kwong, Dr
Facility Name
Tuen Mun Hospital
City
Hong Kong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stewart Y Tung, Dr
12. IPD Sharing Statement
Learn more about this trial
Benefit of Changing Chemoradiotherapy Sequence and Modifying Radiotherapy Schedule for Advanced Nasopharyngeal Cancer
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