NCT02937519

Brief Summary

  1. 1.Observe and compare the chrono-chemotherapy IMRT and conventional chemotherapy and intensity modulated radiotherapy term efficacy of the treatment of locally advanced nasopharyngeal carcinoma.
  2. 2.Evaluation chrono-chemotherapy IMRT and conventional chemotherapy and intensity modulated radiotherapy in locally advanced nasopharyngeal carcinoma safety and tolerability.

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
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2015

Typical duration for phase_2

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

June 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

June 6, 2018

Status Verified

June 1, 2018

Enrollment Period

3 years

First QC Date

August 16, 2016

Last Update Submit

June 2, 2018

Conditions

Esophageal Neoplasms

Keywords

Chronomodulated ChemotherapyIntensity Modulated Radiation TherapyAdvanced Nasopharyngeal Cancer

Outcome Measures

Primary Outcomes (2)

  • Number of Participants with curative effect

    Evaluate the immediate effect at 1year after Concurrent chemo-radiotherapy by RECIST.

    1 year

  • Number of Participants with Adverse Events as a Measure of Safety

    To assess and record nausea, vomiting, oral mucositis, diarrhea and other adverse drug reactions by CTC 3.0.

    5 years

Secondary Outcomes (2)

  • Progression-free survival

    5 years

  • Overall survival

    5 years

Study Arms (2)

Melodie group

EXPERIMENTAL

Induction chrono-chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy

Device: Chrono-chemotherapy pump:MelodieDrug: induction Chrono-chemotherapyDrug: cisplatin chrono-chemotherapyRadiation: intensity-modulated radiation therapy

Routine-Chemotherapy

OTHER

Induction routine-chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy

Device: Routine intravenous dripDrug: induction Routine-chemotherapyDrug: cisplatin routine-chemotherapyRadiation: intensity-modulated radiation therapy

Interventions

Chrono-chemotherapy pump:MelodieDEVICE
Melodie group
Routine intravenous dripDEVICE
Routine-Chemotherapy
induction Chrono-chemotherapyDRUG
Melodie group
induction Routine-chemotherapyDRUG
Routine-Chemotherapy
cisplatin chrono-chemotherapyDRUG
Melodie group
cisplatin routine-chemotherapyDRUG
Routine-Chemotherapy
intensity-modulated radiation therapyRADIATION
Melodie groupRoutine-Chemotherapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • initial treatment of advanced nasopharyngeal carcinoma Ⅲ-Ⅳ patients with pathologically confirmed (according to 2010 UICC staging, T3-4, N0-3), without evidence of distant metastasis (M0). Have measurable tumor lesions.
  • KPS≥70 points.
  • the age of 18-70 years old, male or female.
  • no major organ dysfunction; normal bone marrow function (WBC ≥4.0 × 109 / L, platelets ≥100 × 109 / L, hemoglobin ≥90g / L), normal liver function (total bilirubin, alanine aminotransferase, aspartate aminotransferase ≤1.5 times the upper limit of normal), normal renal function (creatinine ≤ 1.5 times upper limit of normal).
  • understand this study and signed informed consent.

You may not qualify if:

  • distant metastasis.
  • who had received prior chemotherapy.
  • patients have physical or mental illness, and by researchers believe that patients can not be completely or fully understood in this study possible complications.
  • pregnancy (via the urine or serum β-HCG test confirmed) or during lactation.
  • serious complications, such as uncontrolled hypertension, heart failure, diabetes and so on.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, 550000, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Central Study Contacts

Hang Jiang, Bachelor degree

CONTACT

0851-86512802233956010@qq.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician/Professor

Study Record Dates

First Submitted

August 16, 2016

First Posted

October 18, 2016

Study Start

June 1, 2015

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

June 6, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will share

Locations

CN(1)