Ignite Creation Date:
2024-05-05 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003040
Status:
TERMINATED
Last Update Posted:
2012-06-15
First Post:
1999-11-01
Brief Title:
S9709 Laser Surgery Plus Radiation Therapy in Treating Patients With Early Stage Cancer of the Larynx
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase II Study to Evaluate Transoral CO2 Laser Supraglottic Laryngectomy and Irradiation in Stage I II and III Squamous Cell Carcinoma of the Supraglottic Larynx
Status:
TERMINATED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Laser surgery for cancer of the larynx may have fewer side effects and improve recovery Radiation therapy uses high-energy x-rays to damage tumor cells Combining radiation therapy and laser surgery may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of laser surgery plus radiation therapy in treating patients with early stage cancer of the larynx
PURPOSE Phase II trial to study the effectiveness of laser surgery plus radiation therapy in treating patients with early stage cancer of the larynx
Detailed Description:
OBJECTIVES I Assess the feasibility of treating untreated stage I II and selected stage III squamous cell carcinoma of the supraglottic larynx with endoscopic surgery and irradiation II Estimate the 3 year progression free survival and describe the location of disease progression
OUTLINE Patients receive carbon dioxide laser laryngectomy within 28 days following protocol registration Patients with N1 disease may undergo an optional neck dissection ipsilateral to the neck mass Neck dissection includes complete removal of at least lymph node levels 2-4 Radiation therapy begins 14 days following laser surgery Patients are followed every 3 months for the first year every 6 months for the second year and every 12 months thereafter until death
PROJECTED ACCRUAL There will be 50 patients accrued into this study in 3 years with an estimated accrual rate of 20 patients per year
OUTLINE Patients receive carbon dioxide laser laryngectomy within 28 days following protocol registration Patients with N1 disease may undergo an optional neck dissection ipsilateral to the neck mass Neck dissection includes complete removal of at least lymph node levels 2-4 Radiation therapy begins 14 days following laser surgery Patients are followed every 3 months for the first year every 6 months for the second year and every 12 months thereafter until death
PROJECTED ACCRUAL There will be 50 patients accrued into this study in 3 years with an estimated accrual rate of 20 patients per year
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 |
|---|---|---|---|
| S9709 | OTHER | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| U10CA032102 | NIH | None | None |