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

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ClinicalTrials.gov Identifier: NCT01609114
Recruitment Status : Unknown
Verified May 2013 by Far Eastern Memorial Hospital.
Recruitment status was:  Active, not recruiting
First Posted : May 31, 2012
Last Update Posted : May 10, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease
Head and Neck Cancer

Study Design

Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Irradiation Modulates the Pharmacokinetics of Anticancer Drugs for Head and Neck Cancer
Study Start Date : April 2012
Estimated Primary Completion Date : July 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
control groups
chemotherapy (C/T) is applied in the morning. After 4-6 hrs, RT is delivered (according to the clinical practice).
experimental groups
RT is delivered in the morning. After 4-6 hrs, C/T is applied.


Outcome Measures

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609114


Locations
Taiwan
Far Eastern Memorial Hospital
New Taipei city, Taiwan, 220
Sponsors and Collaborators
Far Eastern Memorial Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT01609114     History of Changes
Other Study ID Numbers: FEMH No.:100163-F
First Posted: May 31, 2012    Key Record Dates
Last Update Posted: May 10, 2013
Last Verified: May 2013

Keywords provided by Far Eastern Memorial Hospital:
phenomena and mechanism of RT-PK
fact for different anticancer drugs
different part in human

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms