Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006360
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2000-10-04
Brief Title:
Radiation Therapy in Treating Patients With Stage II or Stage III Oropharyngeal Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
Conformal and Intensity Modulated Irradiation for Oropharyngeal Cancer
Status:
COMPLETED
Status Verified Date:
2016-12
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 Radiation therapy uses high-energy x-rays to damage tumor cells
PURPOSE Phase III trial to study the effectiveness of radiation therapy in treating patients who have stage II or stage III oropharyngeal cancer
PURPOSE Phase III trial to study the effectiveness of radiation therapy in treating patients who have stage II or stage III oropharyngeal cancer
Detailed Description:
OBJECTIVES
Assess target coverage and major salivary gland sparing in patients with stage II or III oropharyngeal cancer treated with intensity-modulated radiotherapy
Determine the nature and prevalence of acute and late side effects of this treatment in these patients
Determine the rate and pattern of locoregional tumor recurrence in these patients after this treatment
OUTLINE This is a multicenter study
Patients receive 3-D conformal radiotherapy andor intensity-modulated radiotherapy daily 5 days a week for 6 weeks in an effort to spare major salivary glands
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL Approximately 57-64 patients will be accrued for this study over 27 months
Assess target coverage and major salivary gland sparing in patients with stage II or III oropharyngeal cancer treated with intensity-modulated radiotherapy
Determine the nature and prevalence of acute and late side effects of this treatment in these patients
Determine the rate and pattern of locoregional tumor recurrence in these patients after this treatment
OUTLINE This is a multicenter study
Patients receive 3-D conformal radiotherapy andor intensity-modulated radiotherapy daily 5 days a week for 6 weeks in an effort to spare major salivary glands
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL Approximately 57-64 patients will be accrued for this study over 27 months
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 |
|---|---|---|---|
| RTOG-H-0022 | None | None | None |
| CDR0000068231 | None | None | None |