Clinical trial NCT01609114: Irradiation Modulates the Pharmacokinetics of Anticancer Drugs for Head and Neck Cancer
Official title: Irradiation Modulates the Pharmacokinetics of Anticancer Drugs for Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head and Neck Cancer
Keywords: phenomena and mechanism of RT-PK
fact for different anticancer drugs
different part in human
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2012-05-31
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chemotherapy-naive patients with histologically confirmed, locally advanced head and neck, nasopharyngeal cancers, who prepares for concurrent chemoradiation therapy as definitive or adjuvant setting, are consecutively enrolled in this study

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.


Eligibility criteria: 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

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC) of'chemo-drugs"
timeFrame: "15, 30, 45, 60, 90, 120 min post-dose"
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei city
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
References:
citation: Hsieh CH, Hou ML, Chiang MH, Tai HC, Tien HJ, Wang LY, Tsai TH, Chen YJ. Head and neck irradiation modulates pharmacokinetics of 5-fluorouracil and cisplatin. J Transl Med. 2013 Sep 26;11:231. doi: 10.1186/1479-5876-11-231.