Clinical trial NCT02937519: Chronomodulated Chemotherapy Followed by Concurrent Chemo-radiotherapy With IMRT in the Treatment of Advanced Nasopharyngeal Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Neoplasms
Keywords: Chronomodulated Chemotherapy
Intensity Modulated Radiation Therapy
Advanced Nasopharyngeal Cancer
Lead sponsor: Guiyang Medical University
Sponsor class: OTHER
Collaborators: name: The Affiliated Cancer Hospital of Xiangya School of Medicine Central South University
name: Sun Yat-sen University
First posted: 2016-10-18
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with curative effect
timeFrame: 1 year
measure: Number of Participants with Adverse Events as a Measure of Safety
timeFrame: 5 years
Secondary outcomes:
measure: Progression-free survival
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Guiyang
country: China
facility: Cancer Hospital of Guizhou Medical University
state: Guizhou
Study officials:
References: