Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00011999
Status:
COMPLETED
Last Update Posted:
2015-11-17
First Post:
2001-03-03
Brief Title:
Chemotherapy and Radiation Therapy Following Surgery in Treating Patients With Head and Neck Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
Phase II Early Postoperative Paclitaxel Followed By Paclitaxel And Cisplatin Concurrent With Radiation Therapy For Resected High Risk Squamous Carcinoma Of The Head And Neck
Status:
COMPLETED
Status Verified Date:
2015-11
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 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 Combining chemotherapy with radiation therapy following surgery may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients who have undergone surgery for stage III or stage IV head and neck cancer
PURPOSE Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients who have undergone surgery for stage III or stage IV head and neck cancer
Detailed Description:
OBJECTIVES
Determine the feasibility of adjuvant paclitaxel followed by radiotherapy with concurrent paclitaxel and cisplatin in patients undergoing gross complete resection of high-risk stage III or IV squamous cell carcinoma of the head and neck
Determine the disease-free and overall survival of patients treated with this regimen
Determine the acute and chronic toxicity of this regimen in these patients
Determine the patterns of failure in patients treated with this regimen
OUTLINE Patients receive adjuvant therapy beginning 7-14 days after gross total surgical resection Patients receive paclitaxel IV over 1 hour on days 1 8 and 15 Beginning on approximately day 22 patients undergo radiotherapy once daily 5 days a week for 55-65 weeks Patients also receive paclitaxel IV over 1 hour followed by cisplatin IV over 1-3 hours on days 43 50 and 57 Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study within 11 months
Determine the feasibility of adjuvant paclitaxel followed by radiotherapy with concurrent paclitaxel and cisplatin in patients undergoing gross complete resection of high-risk stage III or IV squamous cell carcinoma of the head and neck
Determine the disease-free and overall survival of patients treated with this regimen
Determine the acute and chronic toxicity of this regimen in these patients
Determine the patterns of failure in patients treated with this regimen
OUTLINE Patients receive adjuvant therapy beginning 7-14 days after gross total surgical resection Patients receive paclitaxel IV over 1 hour on days 1 8 and 15 Beginning on approximately day 22 patients undergo radiotherapy once daily 5 days a week for 55-65 weeks Patients also receive paclitaxel IV over 1 hour followed by cisplatin IV over 1-3 hours on days 43 50 and 57 Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study within 11 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 |
|---|---|---|---|
| CDR0000068469 | None | None | None |