Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003777
Status:
TERMINATED
Last Update Posted:
2022-01-26
First Post:
1999-11-01
Brief Title:
Surgery Radiation Therapy and Combination Chemotherapy in Treating Patients With Recurrent Head and Neck Cancer
Sponsor:
Abramson Cancer Center at Penn Medicine
Organization:
Abramson Cancer Center at Penn Medicine
Study Overview
Official Title:
A Pilot Study of Combined Modality Therapy for Recurrent Head and Neck Carcinoma
Status:
TERMINATED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left institution
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 Drugs such as amifostine may prevent the side effects of radiation therapy Combining more than one drug and combining radiation therapy and surgery with chemotherapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining surgery radiation therapy and combination chemotherapy in treating patients who have recurrent head and neck cancer that has been treated previously with radiation therapy
PURPOSE Phase II trial to study the effectiveness of combining surgery radiation therapy and combination chemotherapy in treating patients who have recurrent head and neck cancer that has been treated previously with radiation therapy
Detailed Description:
OBJECTIVES
Determine the effectiveness and toxic effects of intensive salvage therapy and radiotherapy in previously irradiated patients with recurrent head and neck cancer
Determine the feasibility and effectiveness of amifostine at limiting or minimizing side effects of repeat irradiation in these patients
OUTLINE Patients undergo surgical resection of gross disease if not already done followed by 4-6 weeks of rest Patients receive radiotherapy over 5 consecutive days on weeks 1 2 4 and 5 Intravenous cisplatin is administered on days 1-3 and 29-31 Intravenous amifostine is administered 15-30 minutes prior to radiotherapy and cisplatin therapy Patients receive fluorouracil IV continuously on days 1-4 and 29-32
Patients are followed every month for 1 year every 2 months for 1 year every 3 months for 1 year every 4 months for 1 year then every 6 months thereafter
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study
Determine the effectiveness and toxic effects of intensive salvage therapy and radiotherapy in previously irradiated patients with recurrent head and neck cancer
Determine the feasibility and effectiveness of amifostine at limiting or minimizing side effects of repeat irradiation in these patients
OUTLINE Patients undergo surgical resection of gross disease if not already done followed by 4-6 weeks of rest Patients receive radiotherapy over 5 consecutive days on weeks 1 2 4 and 5 Intravenous cisplatin is administered on days 1-3 and 29-31 Intravenous amifostine is administered 15-30 minutes prior to radiotherapy and cisplatin therapy Patients receive fluorouracil IV continuously on days 1-4 and 29-32
Patients are followed every month for 1 year every 2 months for 1 year every 3 months for 1 year every 4 months for 1 year then every 6 months thereafter
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study
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 |
|---|---|---|---|
| NCI-V99-1518 | None | None | None |
| UPCC-6398 | None | None | None |
| ALZA-98-023-ii | None | None | None |