Benefit of Changing Chemoradiotherapy Sequence and Modifying Radiotherapy Schedule for Advanced Nasopharyngeal Cancer

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by Hospital Authority, Hong Kong
Sponsor:
Collaborator:
Hong Kong Nasopharyngeal Cancer Study Group Limited
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00577057
First received: December 18, 2007
Last updated: August 21, 2013
Last verified: August 2013
  Purpose

The objectives of this clinical study are threefold:

  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.

Condition Intervention
Nasopharyngeal Neoplasms
Procedure: Conventional Radiotherapy
Procedure: Accelerated Radiotherapy
Drug: Cisplatin
Drug: 5-fluorouracil
Drug: Capecitabine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hospital Authority, Hong Kong:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 5-year ]
  • Overall Survival [ Time Frame: 5-year ]

Secondary Outcome Measures:
  • Overall / Locoregional / Distant Failure Free Rate [ Time Frame: 5-year ]
  • Chemotherapy and RT toxicity [ Time Frame: within 90 day from commencement of RT ]
  • Late Toxicity [ Time Frame: 5-year ]

Estimated Enrollment: 798
Study Start Date: September 2006
Estimated Study Completion Date: August 2013
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00577057

Contacts
Contact: Anne WM Lee, Cos (852) 2595 4173 awmlee@ha.org.hk

Locations
China
Pamela Youde Nethersole Eastern Hospital Not yet recruiting
Hong Kong, China
Queen Mary Hospital Not yet recruiting
Hong Kong, China
Sub-Investigator: Dora Kwong, Dr         
Queen Elizabeth Hospital Not yet recruiting
Hong Kong, China
Sub-Investigator: Roger Ngan, Dr         
Princess Margaret Hospital Not yet recruiting
Hong Kong, China
Sub-Investigator: Ashley Cheng, Dr         
Prince of Wales Hospital Not yet recruiting
Hong Kong, China
Tuen Mun Hospital Not yet recruiting
Hong Kong, China
Sub-Investigator: Stewart Y Tung, Dr         
Sponsors and Collaborators
Hospital Authority, Hong Kong
Hong Kong Nasopharyngeal Cancer Study Group Limited
Investigators
Principal Investigator: Anne WM Lee, Cos Clinical Oncology, Pamela Youde Nethersole Eastern Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00577057     History of Changes
Other Study ID Numbers: HKEC-2006-120, HARECCTR0500062, NPC-0501
Study First Received: December 18, 2007
Last Updated: August 21, 2013
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:
Nasopharyngeal Carcinoma
Stage III - IVB

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Fluorouracil
Capecitabine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014