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

Nasopharyngeal Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00577057
• Other study ID #: HKEC-2006-120
• Secondary ID: HARECCTR0500062N
• Status: Not yet recruiting
• Phase: N/A
• First received: December 18, 2007
• Last updated: August 21, 2013
• Start date: September 2006
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: Hospital Authority, Hong Kong
• Contact: Anne WM Lee, Cos
• Phone: (852) 2595 4173
• Email: awmlee[@]ha.org.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 798
• Est. completion date: August 2013
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Nasopharyngeal Neoplasms

Intervention

Procedure:
• Conventional Radiotherapy

• Accelerated Radiotherapy

Drug:
• Cisplatin

• 5-fluorouracil

• Capecitabine

Locations

Country	Name	City	State
China	Pamela Youde Nethersole Eastern Hospital	Hong Kong
China	Prince of Wales Hospital	Hong Kong
China	Princess Margaret Hospital	Hong Kong
China	Queen Elizabeth Hospital	Hong Kong
China	Queen Mary Hospital	Hong Kong
China	Tuen Mun Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Authority, Hong Kong	Hong Kong Nasopharyngeal Cancer Study Group Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		5-year
Primary	Overall Survival		5-year
Secondary	Overall / Locoregional / Distant Failure Free Rate		5-year
Secondary	Chemotherapy and RT toxicity		within 90 day from commencement of RT
Secondary	Late Toxicity		5-year

External Links

•   HAREC Clinical Trial Registry