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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01609114
First received: April 27, 2012
Last updated: May 8, 2013
Last verified: May 2013
  Purpose

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
Head and Neck Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Irradiation Modulates the Pharmacokinetics of Anticancer Drugs for Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by Far Eastern Memorial Hospital:

Primary Outcome Measures:
  • Area under the plasma concentration versus time curve (AUC) of'chemo-drugs" [ Time Frame: "15, 30, 45, 60, 90, 120 min post‐dose" ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: April 2012
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609114

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

No publications provided

Responsible Party: Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT01609114     History of Changes
Other Study ID Numbers: FEMH No.:100163-F
Study First Received: April 27, 2012
Last Updated: May 8, 2013
Health Authority: Taiwan: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 23, 2014