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Irradiation Modulates the Pharmacokinetics of Anticancer Drugs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Far Eastern Memorial Hospital

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.

Condition or disease
Rectal Cancer Cervical Cancer

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Study Start Date : July 2011
Estimated Primary Completion Date : December 2015

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).

Primary Outcome Measures :
  1. all cause mortality [ Time Frame: one year ]

Biospecimen Retention:   Samples With DNA
whole blood collection

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Far Eastern Memorial Hospital Identifier: NCT01755585    
Other Study ID Numbers: FEMH No. 099148-F
First Posted: December 24, 2012    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: January 2014
Keywords provided by Far Eastern Memorial Hospital:
Radiation therapy
Matrix Metalloproteinase
Additional relevant MeSH terms:
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Rectal Neoplasms
Uterine Cervical Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases