NCT02500940

Brief Summary

The purpose of this study is to investigate the impact of different neoadjuvant chemotherapy schedules of cisplatin and 5-FU on acute toxicity, tumor response, and long-term survival in patients with advanced nasopharyngeal carcinoma

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2015

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 17, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

July 17, 2015

Status Verified

July 1, 2015

Enrollment Period

1 year

First QC Date

June 22, 2015

Last Update Submit

July 14, 2015

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Tumor response by RECIST version 1.1

    According to RECIST version 1.1

    5 years

  • Overall survival

    5 years

Secondary Outcomes (1)

  • Acute toxicity by CTCAE deifnition

    6 months

Study Arms (2)

Control group

EXPERIMENTAL

Neoadjuvant chemotherapy with tri-weekly cisplatin plus fluorouracil × 3 cycles (cisplatin 100 mg/m2, day 1, followed by fluorouracil 1000 mg/m2/d, days 1-4 continuous iv infusion, repeated every 3 weeks) + Intensity-Modulated Radiation Therapy ≧ 70 Gy/35 fractions

Drug: CisplatinDrug: FluorouracilRadiation: Radiation therapy

Test group

ACTIVE COMPARATOR

Neoadjuvant chemotherapy with weekly cisplatin, fluorouracil and leucovorin × 10 weeks (cisplatin 60 mg/m2 at days 1, 15, 29, 43, 57; alternatively with fluorouracil 2500 mg/m2 + leucovorin 250 mg/m2 at days 8, 22, 36, 50, 64) + Intensity-Modulated Radiation Therapy ≧ 70 Gy/35 fractions

Drug: CisplatinDrug: FluorouracilRadiation: Radiation therapyDrug: Leucovorin

Interventions

CisplatinDRUG

Neoadjuvant chemotherapy regimen with cisplatin

Also known as: CDDP
Control groupTest group
FluorouracilDRUG

Neoadjuvant chemotherapy regimen with Fluorouracil

Also known as: 5-FU
Control groupTest group
Radiation therapyRADIATION

Intensity-Modulated Radiation Therapy

Also known as: IMRT
Control groupTest group
LeucovorinDRUG

Neoadjuvant chemotherapy regimen with Leucovorin

Also known as: Calcium folinate
Test group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histological proven NPC.
  • AJCC stage II-IVB.
  • Age ≧ 20 years old.
  • Performance status of ECOG ≦ 2.
  • Adequate liver, renal, and bone marrow functions 5-1 Serum total bilirubin level ≦ 2.5 mg/dl. 5-2 Serum creatinine ≦ 1.6 mg/dl or calculated CCr ≧ 60 cc/min. 5-3 WBC ≧ 3,000/ul 5-4 Platelet count ≧ 100,000/ul
  • Signed informed consent.

You may not qualify if:

  • Presence of distant metastasis.
  • Previous radiotherapy or chemotherapy.
  • History of a malignancy except those treated with curative intent for skin cancer (other than melanoma), in situ cervical cancer, ductal carcinoma in situ (DCIS) of the breast.
  • Severe cardiopulmonary diseases (unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the last 12 months; chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization) or clinically significant psychiatric disorders.
  • Female patients who are pregnant or lactating.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Vaterans General Hospital

Taichung, 40705, Taiwan

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

CisplatinFluorouracilRadiotherapyLeucovorin

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTherapeuticsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and Coenzymes

Study Officials

  • Lin Jin-Ching, Ph.D

    Taichung Veterans General Hospital

    STUDY CHAIR

Central Study Contacts

Lin Jin-Ching, Ph.D

CONTACT

+886-4-23592525jclin@vghtc.gov.tw

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2015

First Posted

July 17, 2015

Study Start

May 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2021

Last Updated

July 17, 2015

Record last verified: 2015-07

Locations

TW(1)