Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002999
Status:
WITHDRAWN
Last Update Posted:
2015-05-27
First Post:
1999-11-01
Brief Title:
S9715 Chemotherapy and Radiation Therapy in Treating Patients With Advanced Cancer of the Nasopharynx
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
S9715 Study of Patients With Advanced Nasopharyngeal Cancers Treated With Chemo-Radiotherapy Phase II
Status:
WITHDRAWN
Status Verified Date:
2015-05
Last Known Status:
None
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 Drugs used in chemotherapy use 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 more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients with advanced cancer of the nasopharynx
PURPOSE Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients with advanced cancer of the nasopharynx
Detailed Description:
OBJECTIVES I Gather additional information and experience regarding the preferred treatment from clinical trial SWOG-8892 chemoradiation for patients with advanced nasopharyngeal cancers NPC II Evaluate survival and progression-free survival and patterns of tumor failure in this new group of patients III Assess severe or lethal toxicities that may be encountered after this regimen is employed more widely IV Collect NPC tumor specimens for ongoing and future clinical correlative research
OUTLINE Patients receive cisplatin by intravenous infusion on day 1 over a 15-20 minute period This is repeated every 21 days for the first three initial treatments Patients also receive radiation therapy once daily five times a week during this cycle of treatment Approximately three weeks after completion of the above treatment patients are given cisplatin by intravenous infusion over 15-20 minutes as above but at a lower dose On the same day as cisplatin infusion patients receive fluorouracil by continuous intravenous infusion over 24 hours for 4 days in a row This is repeated every 28 days for a total of 3 treatments Patients are followed until death
PROJECTED ACCRUAL 100 patients will be accrued
OUTLINE Patients receive cisplatin by intravenous infusion on day 1 over a 15-20 minute period This is repeated every 21 days for the first three initial treatments Patients also receive radiation therapy once daily five times a week during this cycle of treatment Approximately three weeks after completion of the above treatment patients are given cisplatin by intravenous infusion over 15-20 minutes as above but at a lower dose On the same day as cisplatin infusion patients receive fluorouracil by continuous intravenous infusion over 24 hours for 4 days in a row This is repeated every 28 days for a total of 3 treatments Patients are followed until death
PROJECTED ACCRUAL 100 patients will be accrued
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA032102 | NIH | None | None |
| S9715 | OTHER | SWOG | httpsreporternihgovquickSearchU10CA032102 |