Induction Chemotherapy Followed By Chrono-chemotherapy Concurrent With IMRT Of Locally Advanced NPC Clinical Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2019-12-31

Brief Summary

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Comparing induction chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy (chrono-chemotherapy group) with induction chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy (routine-chemotherapy group) in the treatment of locally advanced nasopharyngeal carcinoma, 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.

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Detailed Description

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Conditions

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Nasopharyngeal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Melodie group

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

Group Type EXPERIMENTAL

Chrono-chemotherapy pump:Melodie

Intervention Type DEVICE

induction chemotherapy

Intervention Type DRUG

cisplatin chrono-chemotherapy

Intervention Type DRUG

intensity-modulated radiation therapy

Intervention Type RADIATION

Routine-chemotherapy group

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

Group Type OTHER

Routine intravenous drip

Intervention Type DEVICE

induction chemotherapy

Intervention Type DRUG

intensity-modulated radiation therapy

Intervention Type RADIATION

cisplatin routine-chemotherapy

Intervention Type DRUG

Interventions

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Chrono-chemotherapy pump:Melodie

Intervention Type DEVICE

Routine intravenous drip

Intervention Type DEVICE

induction chemotherapy

Intervention Type DRUG

cisplatin chrono-chemotherapy

Intervention Type DRUG

intensity-modulated radiation therapy

Intervention Type RADIATION

cisplatin routine-chemotherapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Pathological diagnosis of early cure Ⅲ - Ⅳ stage of patients with advanced nasopharyngeal carcinoma (according to the 2010 UICC staging criteria, T3-4, N0-3), no evidence of distant metastasis (M0). A measurable tumor lesions;
2. Karnofsky score≥70;
3. Age 18-70 years old, male or female;
4. No major organ dysfunction; Normal bone marrow hematopoietic function (white blood cell ≥4．0×109／L，platelet≥100×109 /L. hemoglobin ≥100g/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 the upper limit of normal) electrocardiogram does not affect the normal treatment;
5. To understand this study and sign informed consent form.

Exclusion Criteria

1. A distant metastasis;
2. Patients with physical or mental illness, and researchers think that patients can't fully or adequately understand the possible complications of this study;
3. Pregnancy (confirmed by serum or urine β-HCG test) or between lactation period;
4. Serious complications, such as uncontrollable hypertension, heart function failure, diabetes, etc.; 5.Who had received radiation and chemotherapy.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes