Radiation Therapy Alone Compared to Radiation Therapy Plus Chemotherapy in Treating Patients With Previously Untreated Cancer of the Nasopharynx
|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.|
|ClinicalTrials.gov Identifier: NCT00003637|
Recruitment Status : Unknown
Verified January 2006 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : December 19, 2013
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether radiation therapy alone is more effective than radiation therapy plus chemotherapy in treating cancer of the nasopharynx.
PURPOSE: This randomized phase III trial is studying how well radiation therapy and chemotherapy works compared to radiation therapy alone in treating patients with previously untreated cancer of the nasopharynx.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: cisplatin Drug: fluorouracil Radiation: radiation therapy||Phase 3|
- Compare the clinical response, distant metastases, disease-free survival, and overall survival in patients with previously untreated, locally advanced, nonmetastatic nasopharyngeal cancer treated with radiotherapy alone vs concurrent chemoradiotherapy followed by adjuvant chemotherapy.
OUTLINE: This is a randomized study.
Patients are randomized to receive radiotherapy alone (arm I) or concurrent chemoradiotherapy followed by adjuvant chemotherapy (arm II).
- Arm I: Patients receive radiotherapy once daily 5 times a week for 7 weeks.
- Arm II: Patients receive cisplatin IV over 6-8 hours for 4 consecutive days every 3 weeks for 3 courses. Concurrent radiotherapy is given once daily 5 times a week over the 7 week treatment period. This chemoradiotherapy is followed 3 weeks later by adjuvant chemotherapy. Patients receive cisplatin IV and fluorouracil IV over 6-8 hours for 4 consecutive days every 4 weeks for 3 courses.
Patients are followed every 4 months for the first year, every 6 months for the next 2 years, and then annually thereafter until death.
PROJECTED ACCRUAL: A minimum of 200 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Official Title:||Standard Radiotherapy Versus Concurrent Chemo-Radiotherapy Followed by Adjuvant Chemotherapy for Locally Advanced (Non-Metastatic) Nasopharyngeal Cancer|
|Study Start Date :||September 1998|
- Clinical response
- Distant metastases
- Disease-free survival
- Overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003637
|National Cancer Centre - Singapore|
|Singapore, Singapore, 169610|
|Study Chair:||Eu J. Chua, MD||National Cancer Centre, Singapore|