Irradiation Modulates the Pharmacokinetics of Anticancer Drugs for Head and Neck Cancer

• Conditions: Head and Neck Cancer

• Registration Number: NCT01609114
• Lead Sponsor: Far Eastern Memorial Hospital

Brief Summary

The concurrent use of chemotherapy during radiation therapy (CCRT) is now the important treatment stratagem for locally advanced head and neck cancer or nasopharyngeal cancer (NPC). For these cases, 5-Fluorouracil (5-FU) and cisplatin (CDDP) are the most commonly used agents of CCRT. It plays an important role to improve the treatment outcome and increases the opportunities for organ preservation.

In the past, Radiotherapy (RT) was solely used as a local treatment and its effect was estimated by local effect model. However, growing evidence shows that irradiation has direct DNA damage-dependent effects as well as sending signals to neighboring cells. Recently, the investigators reported that abdominal irradiation could significantly modulate the systemic pharmacokinetics of 5-FU at 0.5 Gy, off-target area in clinical practice, and at 2 Gy, the daily treatment dose for target treatment in an experimental rat model. Additionally, the results from a clinical investigation showed that colorectal cancer patients with lower AUC of 5-FU during adjuvant chemotherapy had lower disease-free survival. Taken together, these lines of evidence support the importance and necessity to search for the mediators responsible for the unexpected effect of local RT on systemic pharmacokinetics of chemotherapeutic agents, such as 5-FU.

In the present study, the investigators examined whether the phenomena and mechanism of RT-PK(pharmacokinetics) is a fact for different anticancer drugs and for different part in human.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-27
• Study First Submitted QC: 2012-05-29
• Study First Posted: 2012-05-31
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-08
• Last Update Posted: 2013-05-10
• Primary Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• locally advanced head and neck, nasopharyngeal cancers, who prepares for concurrent chemoradiation therapy as definitive or adjuvant setting

Exclusion Criteria

• previous cancer history；abnormal function of liver and kidney, immunol disease or hematologic disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve (AUC) of'chemo-drugs"	"15, 30, 45, 60, 90, 120 min post-dose"

Trial Locations

Locations (1)

Far Eastern Memorial Hospital; 🇨🇳 New Taipei city, Taiwan