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

Feng Jing

Status and phase: Unknown; Phase 2

Conditions: Nasopharyngeal Carcinoma

Treatments: Drug: cisplatin chrono-chemotherapy; Radiation: intensity-modulated radiation therapy; Device: Chrono-chemotherapy pump:Melodie; Drug: cisplatin routine-chemotherapy; Device: Routine intravenous drip; Drug: induction chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02187315

20140501

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Melodie group

Experimental group

Description:

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

Treatment:

Device: Chrono-chemotherapy pump:Melodie

Radiation: intensity-modulated radiation therapy

Drug: induction chemotherapy

Drug: cisplatin chrono-chemotherapy

Routine-chemotherapy group

Other group

Description:

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

Treatment:

Device: Routine intravenous drip

Radiation: intensity-modulated radiation therapy

Drug: cisplatin routine-chemotherapy

Drug: induction chemotherapy