Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002747
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
1999-11-01
Brief Title:
Surgery and Radiation Therapy With or Without Chemotherapy in Treating Patients With Mouth Cancer
Sponsor:
European Institute of Oncology
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
RANDOMIZED TRIAL OF NEOADJUVANT CHEMOTHERAPY AND SURGERY - RADIOTHERAPY VERSUS SURGEERY - RADIOTHERAPY IN OPERABLE SQUAMOUS CELL CARCINOMA OF THE ORAL CAVITY
Status:
UNKNOWN
Status Verified Date:
2007-05
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 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 It is not yet known if surgery plus radiation therapy is more effective with or without chemotherapy for treating mouth cancer
PURPOSE Randomized phase III trial to compare the effectiveness of surgery and radiation therapy with or without chemotherapy in treating patients with stage II stage III or stage IV mouth cancer
PURPOSE Randomized phase III trial to compare the effectiveness of surgery and radiation therapy with or without chemotherapy in treating patients with stage II stage III or stage IV mouth cancer
Detailed Description:
OBJECTIVES I Assess the short- and long-term local control rates disease-free survival and overall survival following treatment with neoadjuvant cisplatin plus fluorouracil followed by surgery with or without radiotherapy vs surgery alone with or without radiotherapy in patients with previously untreated stage II-IV squamous cell carcinoma of the oral cavity II Assess the prognostic significance of clinical and pathologic responses to neoadjuvant chemotherapy in these patients III Compare the short- and long-term toxic effects of these two regimens
OUTLINE This is a randomized multicenter study Patients are stratified by center and nodal status N0 vs N1-2 vs N3 Patients are randomized to one of two treatment arms Arm I Patients receive cisplatin IV on day 1 and fluorouracil IV continuously on days 1-5 Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity Patients with stable disease after 2 courses or progressive disease at any time proceed to surgery Patients undergo resection of the primary tumor site and possible nodal dissection no sooner than 2 weeks after completion of chemotherapy Patients then undergo radiotherapy over 5-6 weeks no later than 8 weeks after surgery Arm II Patients undergo surgery and radiotherapy as in arm I Patients are followed every 3 months for 1 year every 6 months for 2 years and then yearly thereafter
PROJECTED ACCRUAL A total of 240 patients will be accrued for this study over 9 years
OUTLINE This is a randomized multicenter study Patients are stratified by center and nodal status N0 vs N1-2 vs N3 Patients are randomized to one of two treatment arms Arm I Patients receive cisplatin IV on day 1 and fluorouracil IV continuously on days 1-5 Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity Patients with stable disease after 2 courses or progressive disease at any time proceed to surgery Patients undergo resection of the primary tumor site and possible nodal dissection no sooner than 2 weeks after completion of chemotherapy Patients then undergo radiotherapy over 5-6 weeks no later than 8 weeks after surgery Arm II Patients undergo surgery and radiotherapy as in arm I Patients are followed every 3 months for 1 year every 6 months for 2 years and then yearly thereafter
PROJECTED ACCRUAL A total of 240 patients will be accrued for this study over 9 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 |
|---|---|---|---|
| CNR-012309 | None | None | None |