Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003637
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Radiation Therapy Alone Compared to Radiation Therapy Plus Chemotherapy in Treating Patients With Previously Untreated Cancer of the Nasopharynx
Sponsor:
National Cancer Centre Singapore
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Standard Radiotherapy Versus Concurrent Chemo-Radiotherapy Followed by Adjuvant Chemotherapy for Locally Advanced Non-Metastatic Nasopharyngeal Cancer
Status:
UNKNOWN
Status Verified Date:
2006-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
OBJECTIVES
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-98047 | None | None | None |
| NMRC-SQNP01 | None | None | None |