Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Irradiation Modulates the Pharmacokinetics of Anticancer Drugs

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01755585
First received: December 19, 2012
Last updated: January 19, 2014
Last verified: January 2014
  Purpose

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
Rectal Cancer
Cervical Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Far Eastern Memorial Hospital:

Primary Outcome Measures:
  • all cause mortality [ Time Frame: one year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood collection


Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT01755585     History of Changes
Other Study ID Numbers: FEMH No. 099148-F
Study First Received: December 19, 2012
Last Updated: January 19, 2014
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Far Eastern Memorial Hospital:
Radiation therapy
5-fluorouracil
Cisplatin
Pharmacokinetics
Matrix Metalloproteinase

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014