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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01755585
Other study ID # FEMH No. 099148-F
Secondary ID
Status Enrolling by invitation
Phase N/A
First received December 19, 2012
Last updated January 19, 2014
Start date July 2011

Study information

Verified date January 2014
Source Far Eastern Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 40
Est. completion date
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Far Eastern Memorial Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary all cause mortality one year No
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