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

Phase 2

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

• Registration Number: NCT02937519
• Lead Sponsor: Guiyang Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-08-16
• Study First Submitted QC: 2016-10-16
• Study First Posted: 2016-10-18
• Status Verified: 2018-06
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Last Update Submitted: 2018-06-02
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Cancer Hospital of Guizhou Medical University; 🇨🇳 Guiyang, Guizhou, China