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

Esophageal Neoplasms Clinical Trial

Official title:

Multi-center Phase II Clinical Randomized Study of Chronomodulated Chemotherapy Followed by Concurrent Chemo-radiotherapy With IMRT in the Treatment of Advanced Nasopharyngeal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02937519
• Other study ID #: 2016080201
• Status: Recruiting
• Phase: Phase 2
• Start date: June 2015
• Est. completion date: June 2018

Study information

• Verified date: June 2018
• Source: Guiyang Medical University
• Contact: Hang Jiang, Bachelor degree
• Phone: 0851-86512802
• Email: 233956010[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• initial treatment of advanced nasopharyngeal carcinoma ?-? 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 ß-HCG test confirmed) or during lactation.

• serious complications, such as uncontrolled hypertension, heart failure, diabetes and so on.

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Nasopharyngeal Neoplasms

Intervention

Device:
• Chrono-chemotherapy pump:Melodie

• Routine intravenous drip

Drug:
• induction Chrono-chemotherapy

• induction Routine-chemotherapy

• cisplatin chrono-chemotherapy

• cisplatin routine-chemotherapy

Radiation:
• intensity-modulated radiation therapy

Locations

Country	Name	City	State
China	Cancer Hospital of Guizhou Medical University	Guiyang	Guizhou

Sponsors (3)

Lead Sponsor	Collaborator
Guiyang Medical University	Sun Yat-sen University, The Affiliated Cancer Hospital of Xiangya School of Medicine Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with curative effect	Evaluate the immediate effect at 1year after Concurrent chemo-radiotherapy by RECIST.	1 year
Primary	Number of Participants with Adverse Events as a Measure of Safety	To assess and record nausea, vomiting, oral mucositis, diarrhea and other adverse drug reactions by CTC 3.0.	5 years
Secondary	Progression-free survival	Evaluate the Progression-free survival at five years after Concurrent chemo-radiotherapy by RECIST.	5 years
Secondary	Overall survival	Evaluate the Overall survival at five years after Concurrent chemo-radiotherapy by RECIST.	5 years