Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002555
Status:
COMPLETED
Last Update Posted:
2012-07-02
First Post:
1999-11-01
Brief Title:
High-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
A PHASE III RANDOMIZED STUDY ON POSTOPERATIVE RADIO- AND CHEMOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED HEAD AND NECK CARCINOMAS
Status:
COMPLETED
Status Verified Date:
2012-06
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 if radiation therapy plus chemotherapy 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 high-dose radiation therapy alone with high-dose radiation therapy plus cisplatin in treating patients with head and neck cancer who have undergone surgery to remove the cancer
PURPOSE Randomized phase III trial to compare the effectiveness of high-dose radiation therapy alone with high-dose radiation therapy plus cisplatin in treating patients with head and neck cancer who have undergone surgery to remove the cancer
Detailed Description:
OBJECTIVES I Determine whether the addition of cisplatin to high-dose postoperative radiotherapy increases the disease-free survival rate of patients with locally advanced head and neck carcinomas at high risk of recurrence following radical surgery
OUTLINE Randomized study Patients are registered and randomized to treatment within 25 days of surgery Arm I Radiotherapy Irradiation of the preoperative primary tumor site with a boost to areas at high risk for recurrence using Co60 equipment 4-6 MV linear accelerators or 6-12 MeV electrons Arm II Radiotherapy plus Single-Agent Chemotherapy Irradiation as in Arm I plus Cisplatin CDDP NSC-119875
PROJECTED ACCRUAL A total of 338 evaluable patients will be studied
OUTLINE Randomized study Patients are registered and randomized to treatment within 25 days of surgery Arm I Radiotherapy Irradiation of the preoperative primary tumor site with a boost to areas at high risk for recurrence using Co60 equipment 4-6 MV linear accelerators or 6-12 MeV electrons Arm II Radiotherapy plus Single-Agent Chemotherapy Irradiation as in Arm I plus Cisplatin CDDP NSC-119875
PROJECTED ACCRUAL A total of 338 evaluable patients will be studied
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 |
|---|---|---|---|
| EORTC-22931 | None | None | None |