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

NCT01609114 | Unknown DMC

• 1 other identifier: FEMH No.:100163-F
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Cancer

Keywords

phenomena and mechanism of RT-PK; fact for different anticancer drugs; different part in human

Outcome Measures

Primary Outcomes (1)

• Area under the plasma concentration versus time curve (AUC) of'chemo-drugs"

  "15, 30, 45, 60, 90, 120 min post-dose"

Study Arms (2)

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 Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• locally advanced head and neck, nasopharyngeal cancers, who prepares for concurrent chemoradiation therapy as definitive or adjuvant setting

You may not qualify if:

• previous cancer history；abnormal function of liver and kidney, immunol disease or hematologic disease

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, Taiwan, 220, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 24066670 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2012
• First Posted: May 31, 2012
• Study Start: April 1, 2012
• Primary Completion: July 1, 2016
• Last Updated: May 10, 2013

Record last verified: 2013-05

Locations

TW (1)