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

August 5, 2019 updated by: Dr. ANNE W M LEE, Hong Kong Nasopharyngeal Cancer Study Group Limited

Randomized Trial to Evaluate Therapeutic Gain by Changing Chemoradiotherapy From Concurrent-adjuvant to Induction-concurrent Sequence, and Radiotherapy From Conventional to Accelerated Fractionation for Advanced Nasopharyngeal Carcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. primary objectives include

    1. comparing induction chemotherapy with Cisplatin + 5-Fluorouracil versus adjuvant chemotherapy with Cisplatin + 5-Fluorouracil(PF-Pvs P-PF)
    2. comparing induction chemotherapy with Cisplatin + Capecitabine versus adjuvant chemotherapy with Cisplatin + 5-Fluorouracil(PX-P vs P-PF)
    3. comparing accelerated fractionation versus conventional fractionation (AF vs CF)radiotherapy.

  2. secondary objectives include

    1. comparing induction chemotherapy with Cisplatin + Capecitabine versus induction chemotherapy with Cisplatin + 5-Fluorouracil(PX-P vs PX-P)
    2. Comparing concurrent-adjuvant (CA) versus induction-concurrent (IC) chemotherapy sequence.

Study Type

Interventional

Enrollment (Actual)

803

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Guangzhou, China
        • Cancer Center, Sun Yat Sen University
      • Hong Kong, China
        • Department of Clinical Oncology, Queen Elizabeth Hospital
      • Hong Kong, China
        • Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital
      • Hong Kong, China
        • Department of Clinical Oncology, Prince of Wales Hospital
      • Hong Kong, China
        • Department of Clinical Oncology, Princess Margaret Hospital
      • Hong Kong, China
        • Department of Clinical Oncology, Queen Mary Hospital
      • Hong Kong, China
        • Department of Clinical Oncology, Tuen Mun Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • histologically proven nasopharyngeal carcinoma for primary treatment with radical intent
  • non-keratinizing or undifferentiated type
  • stage III-IVB (by AJCC/UICC 6th edition)
  • ECOG Performance status less or equal to 2
  • Marrow: WBC >= 4 and platelet >=100
  • Renal: creatinine clearance >=60
  • Informed consent

Exclusion Criteria:

  • Primary treatment with palliative intent
  • WHO type I squamous cell carcinoma or adenocarcinoma
  • Evidence of distant metastases
  • Patient is pregnant or lactating
  • 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 5 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1A
Concurrent-Adjuvant CRT using P-PF regimen and conventional fractionation radiotherapy
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
Experimental: 1B
Concurrent-Adjuvant CRT using P-PF regimen and accelerated fractionation radiotherapy
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
Experimental: 2A
Induction-Concurrent CRT using PF-P regimen and conventional fractionation radiotherapy
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
Experimental: 2B
Induction-Concurrent CRT using PF-P regimen and accelerated fractionation radiotherapy
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
Experimental: 3A
Induction-Concurrent CRT using PX-P regimen and conventional fractionation radiotherapy
Drug: Capecitabine
Dose:1000 mg/m2, BD, Day 1-Day 14 Interval: 21 days Cycles: 3 cycles
Other Names:
  • Xeloda
Experimental: 3B
Induction-Concurrent CRT using PX-P regimen and accelerated fractionation radiotherapy
Drug: Capecitabine
Dose:1000 mg/m2, BD, Day 1-Day 14 Interval: 21 days Cycles: 3 cycles
Other Names:
  • Xeloda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-Free Survival, defined as the time to treatment failure at any site or death due to any cause, at 5-year.
Time Frame: 5 years
5 years
Overall Survival, defined as the time to death due to any cause, at 5-year.
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
overall Failure-Free Rate, defined as time to failure at any site)
Time Frame: 5 years
5 years
Loco-regional Failure-Free Rate, defined as time to local or nodal failure)
Time Frame: 5 years
5 years
Distant Failure-Free Rate, defined as time to distant failure)
Time Frame: 5 years
5 years
Incidence of chemotherapy toxicity and acute RT toxicity grade > 3
Time Frame: treatment
treatment
Time to late toxicity (From the date of randomization to the earliest date of late toxicity grade > 3)
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hong Kong Nasopharyngeal Cancer Study Group Limited

Collaborators

The Hong Kong Anti-Cancer Society
hong Kong Cancer Fund

Investigators

  • Principal Investigator: Anne W.M. Lee, F.R.C.R., Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital, Hong Kong
  • Principal Investigator: Roger K.C. Ngan, F.R.C.R, Department of Clinical Oncology, Quen Elizabeth Hospital, Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

September 20, 2006

First Submitted That Met QC Criteria

September 20, 2006

First Posted (Estimate)

September 21, 2006

Study Record Updates

Last Update Posted (Actual)

August 7, 2019

Last Update Submitted That Met QC Criteria

August 5, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPC-0501 Trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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