Benefit of Adding Chemotherapy And/Or Modification of Radiotherapy Schedule for Advance Nasopharyngeal Carcinoma (T3-4N0-1M0)
Prospective Randomized Study on Therapeutic Gain Achieved By Chemoradiation And/Or Accelerated Radiation For T3-4N0-1M0 Nasopharyngeal Carcinoma
3 other identifiers
interventional
465
1 country
5
Brief Summary
To test the therapeutic ratio of accelerated radiotherapy and/or chemotherapy on locally advanced nasopharyngeal carcinoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 1999
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 21, 2007
CompletedFirst Posted
Study publicly available on registry
November 26, 2007
CompletedJune 16, 2011
June 1, 2011
November 21, 2007
June 14, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Failure free survival rate
5-year
Secondary Outcomes (3)
Overall survival rate
5-year
Disease-specific survival rate
5-year
Complication-free rates
5-year
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Pamela Youde Nethersole Eastern Hospital
Hong Kong, China
Prince of Wales Hospital
Hong Kong, China
Queen Elizabeth Hospital
Hong Kong, China
Queen Mary Hospital
Hong Kong, China
Tuen Mun Hospital
Hong Kong, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne WM Lee, Dr
Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
November 21, 2007
First Posted
November 26, 2007
Study Start
July 1, 1999
Study Completion
June 1, 2007
Last Updated
June 16, 2011
Record last verified: 2011-06