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

Guiyang Medical University

Status and phase: Unknown; Phase 2

Conditions: Esophageal Neoplasms

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02937519

2016080201

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Melodie group

Experimental group

Description:

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

Treatment:

Radiation: intensity-modulated radiation therapy

Drug: induction Chrono-chemotherapy

Drug: cisplatin chrono-chemotherapy

Device: Chrono-chemotherapy pump:Melodie

Routine-Chemotherapy

Other group

Description:

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

Treatment:

Radiation: intensity-modulated radiation therapy

Drug: induction Routine-chemotherapy

Device: Routine intravenous drip

Drug: cisplatin routine-chemotherapy