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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00577057

Enrollment

798

Registered

2007-12-19

Start date

2006-09-30

Completion date

2013-08-31

Last updated

2013-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal Neoplasms

Keywords

Nasopharyngeal Carcinoma, Stage III - IVB

Brief 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.

Interventions

PROCEDUREConventional Radiotherapy

PROCEDUREAccelerated Radiotherapy

DRUGCisplatin

DRUG5-fluorouracil

DRUGCapecitabine

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame
Progression-free survival	5-year
Overall Survival	5-year

Secondary

Measure	Time frame
Overall / Locoregional / Distant Failure Free Rate	5-year
Chemotherapy and RT toxicity	within 90 day from commencement of RT
Late Toxicity	5-year

Countries

China

Contacts

Primary ContactAnne WM Lee, Cos

awmlee@ha.org.hk(852) 2595 4173

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026