Benefit of Changing Chemoradiotherapy Sequence and Modifying Radiotherapy Schedule for Advanced Nasopharyngeal Cancer
This study is not yet open for participant recruitment.
Verified July 2010 by Hospital Authority, Hong Kong
Sponsor:
Hospital Authority, Hong Kong
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: July 6, 2010
Last verified: July 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| 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
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 | |
| Tuen Mun Hospital | Not yet recruiting |
| Hong Kong, China | |
| Sub-Investigator: Stewart Y Tung, Dr | |
| Prince of Wales Hospital | Not yet recruiting |
| Hong Kong, China | |
| Princess Margaret Hospital | Not yet recruiting |
| Hong Kong, China | |
| Sub-Investigator: Ashley Cheng, 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: | July 6, 2010 |
| Health Authority: | Hong Kong: Ethics Committee |
Keywords provided by Hospital Authority, Hong Kong:
|
Nasopharyngeal Carcinoma Stage III - IVB |
Additional relevant MeSH terms:
|
Neoplasms Nasopharyngeal Neoplasms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site Nasopharyngeal Diseases Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases Capecitabine Cisplatin |
Fluorouracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 16, 2013