Benefit of Adding Chemotherapy for Advance Nasopharyngeal Carcinoma (T1-4N2-3M0)
Primary Purpose
Nasopharyngeal Neoplasms, Carcinoma, Squamous Cell
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Conventional RT
Cisplatin
5-fluorouracil
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Neoplasms focused on measuring Nasopharyngeal Carcinoma, T1-4N2-3M0
Eligibility Criteria
Inclusion Criteria:
- Undifferentiated or non-keratinizing carcinoma
- Tumor staged as N2-3
- 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
Sites / Locations
- Pamela Youde Nethersole Eastern Hospital
- Queen Elizabeth Hospital
- Queen Mary Hospital
- Tuen Mun Hospital
Outcomes
Primary Outcome Measures
Failure free survival rate
Secondary Outcome Measures
Disease-specific survival rate
Overall survival rate
Complication-free rates
Full Information
NCT ID
NCT00563927
First Posted
November 21, 2007
Last Updated
July 6, 2010
Sponsor
Hospital Authority, Hong Kong
Collaborators
Hong Kong Nasopharyngeal Cancer Study Group Limited
1. Study Identification
Unique Protocol Identification Number
NCT00563927
Brief Title
Benefit of Adding Chemotherapy for Advance Nasopharyngeal Carcinoma (T1-4N2-3M0)
Official Title
Prospective Randomized Study on Therapeutic Gain Achieved By Addition of Chemotherapy for T1-4N2-3M0 Nasopharyngeal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2009 (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
To test the therapeutic ratio of additional chemotheray on advanced nasopharyngeal carcinoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Neoplasms, Carcinoma, Squamous Cell
Keywords
Nasopharyngeal Carcinoma, T1-4N2-3M0
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
340 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Conventional RT
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil
Primary Outcome Measure Information:
Title
Failure free survival rate
Time Frame
5 year
Secondary Outcome Measure Information:
Title
Disease-specific survival rate
Time Frame
5-year
Title
Overall survival rate
Time Frame
5-year
Title
Complication-free rates
Time Frame
5-year
10. Eligibility
Sex
All
Maximum Age & Unit of Time
70 Years
Eligibility Criteria
Inclusion Criteria:
Undifferentiated or non-keratinizing carcinoma
Tumor staged as N2-3
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wai Hon LAU, Dr
Organizational Affiliation
Department of Clinical Oncology, Queen Elizabeth Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamela Youde Nethersole Eastern Hospital
City
Hong Kong
Country
China
Facility Name
Queen Elizabeth Hospital
City
Hong Kong
Country
China
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
China
Facility Name
Tuen Mun Hospital
City
Hong Kong
Country
China
12. IPD Sharing Statement
Learn more about this trial
Benefit of Adding Chemotherapy for Advance Nasopharyngeal Carcinoma (T1-4N2-3M0)
We'll reach out to this number within 24 hrs