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Therapeutic Gain by Induction-concurrent Chemoradiotherapy and/or Accelerated Fractionation for Nasopharyngeal Carcinoma

NCT00379262 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 803

Last updated 2019-08-07

No results posted yet for this study

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 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.

Conditions

  • Nasopharyngeal Carcinoma

Interventions

DRUG

Capecitabine

Dose:1000 mg/m2, BD, Day 1-Day 14 Interval: 21 days Cycles: 3 cycles

DRUG

Adjuvant chemotherapy using PF (5-Fluorouracil )

Cisplatin 80 mg/m2 IV + 5-Fluorouracil 1000 mg/m2/day IV infusion for 96 hr every 28 days for 3 cycles

DRUG

Induction chemotherapy using PF (5-Fluorouracil)

Cisplatin 100 mg/m2 IV + 5-Fluorouracil 1000 mg/m2/day IV infusion for 120 hr every 21 days for 3 cycles

Sponsors & Collaborators

  • The Hong Kong Anti-Cancer Society

    collaborator OTHER

  • hong Kong Cancer Fund

    collaborator UNKNOWN

  • Hong Kong Nasopharyngeal Cancer Study Group Limited

    lead OTHER

Principal Investigators

  • Anne W.M. Lee, F.R.C.R. · Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital, Hong Kong

  • Roger K.C. Ngan, F.R.C.R · Department of Clinical Oncology, Quen Elizabeth Hospital, Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2017-05-31
Completion
2018-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00379262 on ClinicalTrials.gov