Fluorouracil, Cisplatin, and Radiation Therapy in Treating Patients With Stage II, Stage III, or Stage IV Nasopharyngeal Cancer
|ClinicalTrials.gov Identifier: NCT00093665|
Recruitment Status : Unknown
Verified October 2006 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : October 8, 2004
Last Update Posted : May 15, 2013
|First Submitted Date ICMJE||October 6, 2004|
|First Posted Date ICMJE||October 8, 2004|
|Last Update Posted Date||May 15, 2013|
|Study Start Date ICMJE||November 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Progression-free survival at 3 years|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00093665 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Fluorouracil, Cisplatin, and Radiation Therapy in Treating Patients With Stage II, Stage III, or Stage IV Nasopharyngeal Cancer|
|Official Title ICMJE||A Phase II Study Of Alternating Chemoradiotherapy For Nasopharyngeal Cancer Using Cisplatin And 5-Fluorouracil|
RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining fluorouracil and cisplatin with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving fluorouracil and cisplatin together with radiation therapy works in treating patients with stage II, stage III, or stage IV nasopharyngeal cancer.
OUTLINE: This is a multicenter study.
Patients receive chemotherapy comprising fluorouracil IV continuously on days 1-5 and cisplatin IV continuously on days 6-7. Beginning 2-3 days after the completion of chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 4 weeks. With 2-3 days between each course, patients receive a second course of chemotherapy, undergo a second course of radiotherapy, and then receive a third course of chemotherapy. Treatment continues in the absence of unacceptable toxicity or disease progression.
Patients are followed for 3 years.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 2 years.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Masking: None (Open Label)
Primary Purpose: Treatment
|Condition ICMJE||Head and Neck Cancer|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Enrollment ICMJE
|Original Enrollment ICMJE||Not Provided|
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
PRIOR CONCURRENT THERAPY:
|Ages||18 Years to 70 Years (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Japan|
|Removed Location Countries|
|NCT Number ICMJE||NCT00093665|
|Other Study ID Numbers ICMJE||AICHI-UHA-HN03-01
CDR0000389425 ( Registry Identifier: PDQ (Physician Data Query) )
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Aichi Cancer Center|
|Collaborators ICMJE||Not Provided|
|PRS Account||National Cancer Institute (NCI)|
|Verification Date||October 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP