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Irradiation Modulates the Pharmacokinetics of Anticancer Drugs

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ClinicalTrials.gov Identifier: NCT01755585
Recruitment Status : Unknown
Verified January 2014 by Far Eastern Memorial Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : December 24, 2012
Last Update Posted : January 22, 2014
Sponsor:
Information provided by (Responsible Party):
Far Eastern Memorial Hospital

Tracking Information
First Submitted Date December 19, 2012
First Posted Date December 24, 2012
Last Update Posted Date January 22, 2014
Study Start Date July 2011
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 21, 2012)
all cause mortality [ Time Frame: one year ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Irradiation Modulates the Pharmacokinetics of Anticancer Drugs
Official Title Not Provided
Brief Summary

Radiation therapy (RT) is used as an effective local treatment modality to inhibit cell proliferation, induce cell death and suppress tumor growth. To improve the treatment outcome, in terms of both locoregional control and survival, the concurrent use of chemotherapy during radiation therapy (CCRT) is now the standard treatment for various malignancies, especially locally advanced cancers. Among the drugs used to enhance RT effect, 5-fluorouracil (5-FU) is one of the most commonly used chemotherapeutic agents of CCRT.

In the past, 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, we 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 investigated whether the phenomena and mechanism of RT-PK is a fact for different anticancer drugs in human.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
whole blood collection
Sampling Method Non-Probability Sample
Study Population Chemotherapy-naive patients with histologically confirmed, locally advanced rectal adenocarcinoma and cervical cancer, who were prepared for concurrent chemoradiation therapy, were consecutively enrolled in this study
Condition
  • Rectal Cancer
  • Cervical Cancer
Intervention Not Provided
Study Groups/Cohorts
  • C/T-RT group
    Chemotherapy (C/T) is applied in the morning. After 2-4 hrs, radiotherapy (RT) is delivered (according to the clinical practice)
  • RT-C/T group
    Radiotherapy (RT) is delivered in the morning. After 2-4 hrs, chemotherapy (C/T) is applied (according to the clinical practice).
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: December 21, 2012)
40
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • World Health Organization (WHO) performance status of 0 or 1
  • Age 18-80 years
  • Locally advanced rectal cancer
  • Locally advanced cervical cancer

Exclusion Criteria:

  • Cancer history
  • Abnormal liver and renal disease
  • Immune disease
  • Hematological disease
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01755585
Other Study ID Numbers FEMH No. 099148-F
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Far Eastern Memorial Hospital
Study Sponsor Far Eastern Memorial Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Far Eastern Memorial Hospital
Verification Date January 2014