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Benefit of Adding Chemotherapy And/Or Modification of Radiotherapy Schedule for Advance Nasopharyngeal Carcinoma (T3-4N0-1M0)

Primary Purpose

Nasopharyngeal Neoplasms, Carcinoma, Squamous Cell

Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Conventional RT
Accelerated RT
Cisplatin
5-fluorouracil
Sponsored by
Hospital Authority, Hong Kong
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Neoplasms focused on measuring Nasopharyngeal Carcinoma, T3-4N0-1M0

Eligibility Criteria

undefined - 70 Years (Child, Adult, Older Adult)All Sexes

Inclusion Criteria:

  • 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

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
  • Prince of Wales Hospital
  • Queen Elizabeth Hospital
  • Queen Mary Hospital
  • Tuen Mun Hospital

Outcomes

Primary Outcome Measures

Failure free survival rate

Secondary Outcome Measures

Overall survival rate
Disease-specific survival rate
Complication-free rates

Full Information

First Posted
November 21, 2007
Last Updated
June 14, 2011
Sponsor
Hospital Authority, Hong Kong
Collaborators
The Hong Kong Nasopharyngeal Cancer Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT00563862
Brief Title
Benefit of Adding Chemotherapy And/Or Modification of Radiotherapy Schedule for Advance Nasopharyngeal Carcinoma (T3-4N0-1M0)
Official Title
Prospective Randomized Study on Therapeutic Gain Achieved By Chemoradiation And/Or Accelerated Radiation For T3-4N0-1M0 Nasopharyngeal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Terminated
Study Start Date
July 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Authority, Hong Kong
Collaborators
The Hong Kong Nasopharyngeal Cancer Study Group

4. Oversight

5. Study Description

Brief Summary
To test the therapeutic ratio of accelerated radiotherapy and/or chemotherapy on locally 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, T3-4N0-1M0

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
465 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Conventional RT
Intervention Type
Procedure
Intervention Name(s)
Accelerated 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
Overall survival rate
Time Frame
5-year
Title
Disease-specific 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 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 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
Anne WM Lee, Dr
Organizational Affiliation
Department of 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
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 And/Or Modification of Radiotherapy Schedule for Advance Nasopharyngeal Carcinoma (T3-4N0-1M0)

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