Overview

This trial is active, not recruiting.

Condition head and neck cancer
Sponsor Far Eastern Memorial Hospital
Start date April 2012
End date July 2016
Trial size 30 participants
Trial identifier NCT01609114, FEMH No.:100163-F

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
chemotherapy (C/T) is applied in the morning. After 4-6 hrs, RT is delivered (according to the clinical practice).
RT is delivered in the morning. After 4-6 hrs, C/T is applied.

Primary Outcomes

Measure
Area under the plasma concentration versus time curve (AUC) of'chemo-drugs"
time frame: "15, 30, 45, 60, 90, 120 min post‐dose"

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

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

Additional Information

Official title Irradiation Modulates the Pharmacokinetics of Anticancer Drugs for Head and Neck Cancer
Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
Information provided to ClinicalTrials.gov by Far Eastern Memorial Hospital.