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

Phase 2

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: induction chemotherapy; Device: Routine intravenous drip; Drug: cisplatin chrono-chemotherapy; Radiation: intensity-modulated radiation therapy; Drug: cisplatin routine-chemotherapy

• Registration Number: NCT02187315
• Lead Sponsor: Feng Jing

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-15
• Status Verified: 2014-07
• Study First Submitted QC: 2014-07-10
• Last Update Submitted: 2014-07-10
• Study First Posted: 2014-07-11
• Last Update Posted: 2014-07-11
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Melodie group	induction chemotherapy	Induction chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy
Routine-chemotherapy group	Routine intravenous drip	Induction chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy
Routine-chemotherapy group	intensity-modulated radiation therapy	Induction chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy
Melodie group	cisplatin chrono-chemotherapy	Induction chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy
Melodie group	intensity-modulated radiation therapy	Induction chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy
Routine-chemotherapy group	induction chemotherapy	Induction chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy
Routine-chemotherapy group	cisplatin routine-chemotherapy	Induction chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety	5 year

Secondary Outcome Measures

Name	Time	Method
Number of Participants with curative effect	1 year

Trial Locations

Locations (1)

The Affiliated Hospital of Guiyang Medical College/The Affiliated Cancer Hospital of Guiyang Medical College/Guizhou Cancer Hospital; 🇨🇳 Guiyang, Guizhou, China