Chronomodulated Chemotherapy Followed by Concurrent Chemo-radiotherapy With IMRT in the Treatment of Advanced Nasopharyngeal Cancer

Multi-center Phase II Clinical Randomized Study of Chronomodulated Chemotherapy Followed by Concurrent Chemo-radiotherapy With IMRT in the Treatment of Advanced Nasopharyngeal Cancer

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02937519

Enrollment

160

Registered

2016-10-18

Start date

2015-06-30

Completion date

2018-06-30

Last updated

2018-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Neoplasms

Keywords

Chronomodulated Chemotherapy, Intensity Modulated Radiation Therapy, Advanced Nasopharyngeal Cancer

Brief summary

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. Evaluation chrono-chemotherapy IMRT and conventional chemotherapy and intensity modulated radiotherapy in locally advanced nasopharyngeal carcinoma safety and tolerability. 3）observing the adverse reaction and effects of two groups,expected chrono-chemotherapy group can achieve lower toxicity, improve the curative effect, for the treatment of nasopharyngeal carcinoma provides a more reasonable way.

Interventions

DEVICEChrono-chemotherapy pump:Melodie

DEVICERoutine intravenous drip

DRUGinduction Chrono-chemotherapy

DRUGinduction Routine-chemotherapy

DRUGcisplatin chrono-chemotherapy

DRUGcisplatin routine-chemotherapy

RADIATIONintensity-modulated radiation therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants with curative effect	1 year	Evaluate the immediate effect at 1year after Concurrent chemo-radiotherapy by RECIST.
Number of Participants with Adverse Events as a Measure of Safety	5 years	To assess and record nausea, vomiting, oral mucositis, diarrhea and other adverse drug reactions by CTC 3.0.

Secondary

Measure	Time frame	Description
Progression-free survival	5 years	Evaluate the Progression-free survival at five years after Concurrent chemo-radiotherapy by RECIST.
Overall survival	5 years	Evaluate the Overall survival at five years after Concurrent chemo-radiotherapy by RECIST.

Countries

China

Contacts

Primary ContactHang Jiang, Bachelor degree

233956010@qq.com0851-86512802

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 29, 2026