Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003862
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
1999-11-01
Brief Title:
Chemotherapy and Radiation Therapy in Treating Patients With Stomach Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase II Trial of Preoperative Chemotherapy and Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Stomach
Status:
COMPLETED
Status Verified Date:
2003-09
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 may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of chemotherapy and radiation therapy in treating patients who have stomach cancer
PURPOSE Phase II trial to study the effectiveness of chemotherapy and radiation therapy in treating patients who have stomach cancer
Detailed Description:
OBJECTIVES
Determine the feasibility of preoperative chemoradiotherapy in patients with potentially resectable adenocarcinoma of the stomach
Determine the pathologic response rate curative resection rate and survival in patients treated with this regimen
Determine the tolerability of this regimen in these patients
OUTLINE Patients receive fluorouracil IV over 24 hours on days 1-21 cisplatin IV over 1 hour on days 1-5 and leucovorin calcium IV over 15 minutes on days 1 8 15 and 22 A second course is administered beginning on day 29
Chemoradiotherapy begins at the end of the second course of chemotherapy and 1 week of rest day 57 Patients receive fluorouracil IV over 24 hours 5 days a week concurrently with radiotherapy for 5 weeks and paclitaxel IV over 3 hours once weekly during these 5 weeks on days 1 8 15 22 and 29
Approximately 4-5 weeks after chemoradiotherapy patients with no evidence of metastatic disease undergo surgical resection
Patients are followed every 3 months for 1 year every 6 months for 5 years then annually thereafter
PROJECTED ACCRUAL A total of 21-49 patients will be accrued for this study within 25 years
Determine the feasibility of preoperative chemoradiotherapy in patients with potentially resectable adenocarcinoma of the stomach
Determine the pathologic response rate curative resection rate and survival in patients treated with this regimen
Determine the tolerability of this regimen in these patients
OUTLINE Patients receive fluorouracil IV over 24 hours on days 1-21 cisplatin IV over 1 hour on days 1-5 and leucovorin calcium IV over 15 minutes on days 1 8 15 and 22 A second course is administered beginning on day 29
Chemoradiotherapy begins at the end of the second course of chemotherapy and 1 week of rest day 57 Patients receive fluorouracil IV over 24 hours 5 days a week concurrently with radiotherapy for 5 weeks and paclitaxel IV over 3 hours once weekly during these 5 weeks on days 1 8 15 22 and 29
Approximately 4-5 weeks after chemoradiotherapy patients with no evidence of metastatic disease undergo surgical resection
Patients are followed every 3 months for 1 year every 6 months for 5 years then annually thereafter
PROJECTED ACCRUAL A total of 21-49 patients will be accrued for this study within 25 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 |
|---|---|---|---|
| CDR0000067026 | None | None | None |