Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002735
Status:
TERMINATED
Last Update Posted:
2015-09-30
First Post:
1999-11-01
Brief Title:
SWOG-9451 Combination Chemo RT For Patients With Stage IIIStage IV Cancer of the Hypopharynx or Tongue
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Induction Chemotherapy Followed By Chemoradiation For Organ Preservation In Patients With Advanced Resectable Cancer Of The Hypopharynx And Base Of Tongue Phase II
Status:
TERMINATED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to poor accrual
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 chemotherapy drug with radiation therapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients with stage III or stage IV cancer of the hypopharynx or tongue
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients with stage III or stage IV cancer of the hypopharynx or tongue
Detailed Description:
OBJECTIVES I Determine the complete histologic response rate which represents the rate of organ preservation to induction with cisplatinfluorouracil followed by radiotherapy plus cisplatin in patients with selected stage IIIIV cancer of the hypopharynx or base of the tongue II Evaluate the feasibility of accruing and treating patients with this regimen in a multi-institutional setting III Determine the overall complete response rate in these patients
OUTLINE This is a multicenter study Patients are stratified according to center and tumor site hypopharynx vs base of tongue Base of tongue stratum closed as of November 15 1998 Regimen A Patients receive cisplatin IV over 90 minutes on days 1 and 22 and fluorouracil IV over 120 minutes on days 1-5 and 22-26 Patients with measurable neck nodes discontinue therapy if disease has progressed by day 22 All patients who achieve complete or partial response at day 43 proceed to regimen B All others proceed to resection followed by radiotherapy off study Regimen B begins within 3-4 weeks of start of second induction course Patients receive cisplatin IV over 90 minutes every 3 weeks for 3 courses Concurrently patients receive radiotherapy 5 days a week for 56 weeks Patients are reassessed at 8-12 weeks after radiotherapy Patients who are disease free are observed Other patients undergo surgical resection of nodes andor primary tumor Patients are followed every 4-6 weeks for 1 year every 2 months for 1 year every 4 months for 2 years every 6 months for 1 year then annually thereafter
PROJECTED ACCRUAL Up to 70 patients 35tumor site will be accrued for this study over 35 years
OUTLINE This is a multicenter study Patients are stratified according to center and tumor site hypopharynx vs base of tongue Base of tongue stratum closed as of November 15 1998 Regimen A Patients receive cisplatin IV over 90 minutes on days 1 and 22 and fluorouracil IV over 120 minutes on days 1-5 and 22-26 Patients with measurable neck nodes discontinue therapy if disease has progressed by day 22 All patients who achieve complete or partial response at day 43 proceed to regimen B All others proceed to resection followed by radiotherapy off study Regimen B begins within 3-4 weeks of start of second induction course Patients receive cisplatin IV over 90 minutes every 3 weeks for 3 courses Concurrently patients receive radiotherapy 5 days a week for 56 weeks Patients are reassessed at 8-12 weeks after radiotherapy Patients who are disease free are observed Other patients undergo surgical resection of nodes andor primary tumor Patients are followed every 4-6 weeks for 1 year every 2 months for 1 year every 4 months for 2 years every 6 months for 1 year then annually thereafter
PROJECTED ACCRUAL Up to 70 patients 35tumor site will be accrued for this study over 35 years
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 | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| SWOG-9451 | OTHER | None | None |