Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002670
Status:
COMPLETED
Last Update Posted:
2014-01-24
First Post:
1999-11-01
Brief Title:
Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer That Has Been Removed During Surgery
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
Phase III Intergroup Trial of Surgery Followed by 1 Radiotherapy vs 2 Radiochemotherapy For Resectable High Risk Squamous Cell Carcinoma of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2014-01
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known whether radiation therapy plus cisplatin is more effective than radiation therapy alone in treating patients with head and neck cancer
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy plus cisplatin with radiation therapy alone in treating patients with head and neck cancer that has been removed during surgery
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy plus cisplatin with radiation therapy alone in treating patients with head and neck cancer that has been removed during surgery
Detailed Description:
OBJECTIVES I Evaluate locoregional control rates patterns of first failure and overall and disease-free survival in patients with advanced squamous cell carcinoma of the head and neck at high risk of locoregional recurrence who are treated postoperatively with concurrent cisplatin and radiotherapy II Compare the toxicity of concurrent chemoradiotherapy vs radiotherapy alone in the postoperative setting
OUTLINE Randomized study Arm I Radiotherapy Involved-field irradiation using Co60 1-6 MV photons or electrons Arm II Radiotherapy plus Single-Agent Chemotherapy Irradiation as in Arm I plus Cisplatin CDDP NSC-119875
PROJECTED ACCRUAL 438 patients will be entered over approximately 5 years
OUTLINE Randomized study Arm I Radiotherapy Involved-field irradiation using Co60 1-6 MV photons or electrons Arm II Radiotherapy plus Single-Agent Chemotherapy Irradiation as in Arm I plus Cisplatin CDDP NSC-119875
PROJECTED ACCRUAL 438 patients will be entered over approximately 5 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 |
|---|---|---|---|
| SWOG-9515 | None | None | None |
| CDR0000064279 | None | None | None |
| E-R9501 | None | None | None |