Overview

This trial is active, not recruiting.

Condition nasopharyngeal carcinoma
Treatments capecitabine, adjuvant chemotherapy using pf (5-fluorouracil ), induction chemotherapy using pf (5-fluorouracil)
Phase phase 3
Sponsor Hong Kong Nasopharyngeal Cancer Study Group Limited
Collaborator The Hong Kong Anti-Cancer Society
Start date September 2006
End date May 2017
Trial size 798 participants
Trial identifier NCT00379262, NPC-0501 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 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Concurrent-Adjuvant CRT using P-PF regimen and conventional fractionation radiotherapy
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)
Concurrent-Adjuvant CRT using P-PF regimen and accelerated fractionation radiotherapy
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)
Induction-Concurrent CRT using PF-P regimen and conventional fractionation radiotherapy
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)
Induction-Concurrent CRT using PF-P regimen and accelerated fractionation radiotherapy
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)
Induction-Concurrent CRT using PX-P regimen and conventional fractionation radiotherapy
capecitabine Xeloda
Dose:1000 mg/m2, BD, Day 1-Day 14 Interval: 21 days Cycles: 3 cycles
(Experimental)
Induction-Concurrent CRT using PX-P regimen and accelerated fractionation radiotherapy
capecitabine Xeloda
Dose:1000 mg/m2, BD, Day 1-Day 14 Interval: 21 days Cycles: 3 cycles

Primary Outcomes

Measure
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
Overall Survival, defined as the time to death due to any cause, at 5-year.
time frame: 5 years

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title 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
Principal investigator Anne W.M. Lee, F.R.C.R.
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Hong Kong Nasopharyngeal Cancer Study Group Limited.