Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112697
Status:
COMPLETED
Last Update Posted:
2021-02-17
First Post:
2005-06-02
Brief Title:
Radiation Therapy and Docetaxel With Either Fluorouracil or Cisplatin as First-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Randomized Phase II Trial Evaluating Radiotherapy-Docetaxel-5 Fluorouracil Association Versus Radiotherapy-Docetaxel-Cisplatin Association in Non Resecables First Line of Chemotherapy in Metastatics Pancreas Cancers Patients
Status:
COMPLETED
Status Verified Date:
2021-02
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 kill tumor cells Drugs used in chemotherapy such as docetaxel fluorouracil and cisplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving radiation therapy together with chemotherapy may kill more tumor cells It is not yet known whether radiation therapy docetaxel and fluorouracil are more effective than radiation therapy docetaxel and cisplatin as first-line therapy in treating pancreatic cancer
PURPOSE This randomized phase II trial is studying radiation therapy docetaxel and fluorouracil to see how well they work as first-line therapy compared to radiation therapy docetaxel and cisplatin in treating patients with metastatic pancreatic cancer that cannot be removed by surgery
PURPOSE This randomized phase II trial is studying radiation therapy docetaxel and fluorouracil to see how well they work as first-line therapy compared to radiation therapy docetaxel and cisplatin in treating patients with metastatic pancreatic cancer that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Compare the 6-month progression-free survival rate in patients with unresectable metastatic adenocarcinoma of the pancreas treated with radiotherapy and docetaxel in combination with either fluorouracil or cisplatin as first-line therapy
Secondary
Compare the toxicity of these regimens in these patients
Compare the objective response rate in patients treated with these regimens
Compare overall survival of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo radiotherapy to the celiac area once daily 5 days a week for 6 weeks Patients also receive docetaxel IV weekly and fluorouracil IV daily for 6 weeks
Arm II Patients undergo radiotherapy and receive docetaxel as in arm I Patients also receive cisplatin IV weekly for 6 weeks
In both arms patients experiencing disease progression after completion of chemoradiotherapy may receive additional courses of chemotherapy
PROJECTED ACCRUAL A total of 80 patients 40 per treatment arm will be accrued for this study within 3 years
Primary
Compare the 6-month progression-free survival rate in patients with unresectable metastatic adenocarcinoma of the pancreas treated with radiotherapy and docetaxel in combination with either fluorouracil or cisplatin as first-line therapy
Secondary
Compare the toxicity of these regimens in these patients
Compare the objective response rate in patients treated with these regimens
Compare overall survival of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo radiotherapy to the celiac area once daily 5 days a week for 6 weeks Patients also receive docetaxel IV weekly and fluorouracil IV daily for 6 weeks
Arm II Patients undergo radiotherapy and receive docetaxel as in arm I Patients also receive cisplatin IV weekly for 6 weeks
In both arms patients experiencing disease progression after completion of chemoradiotherapy may receive additional courses of chemotherapy
PROJECTED ACCRUAL A total of 80 patients 40 per treatment arm will be accrued for this study within 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| EU-20511 | None | None | None |
| FRE-FNCLCC-ACCORD-090201 | None | None | None |