Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416858
Status:
COMPLETED
Last Update Posted:
2014-03-04
First Post:
2006-12-27
Brief Title:
Radiation Therapy and Combination Chemotherapy With or Without Surgery in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed By Surgery
Sponsor:
Federation Francophone de Cancerologie Digestive
Organization:
Federation Francophone de Cancerologie Digestive
Study Overview
Official Title:
Randomized Study of Adjuvant Radiochemotherapy After Surgery Versus Radiochemotherapy Alone in Patients With Locally Advanced Esophageal Cancer
Status:
COMPLETED
Status Verified Date:
2007-04
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 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 combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed Giving these treatments after surgery may kill any tumor cells that remain
PURPOSE This randomized phase III trial is studying radiation therapy together with combination chemotherapy to see how well they work with or without surgery in treating patients with locally advanced esophageal cancer that can be removed by surgery
PURPOSE This randomized phase III trial is studying radiation therapy together with combination chemotherapy to see how well they work with or without surgery in treating patients with locally advanced esophageal cancer that can be removed by surgery
Detailed Description:
OBJECTIVES
Compare the survival of patients with locally advanced esophageal cancer treated with neoadjuvant radiotherapy and chemotherapy comprising fluorouracil and cisplatin followed by surgery or radiotherapy and chemotherapy
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to gender histology epidermoid vs glandular response to induction therapy complete vs partial and tumor differentiation little differentiated vs undifferentiatedgood vs moderately differentiated
Induction therapy All patients receive induction therapy comprising fluorouracil IV continuously over 24 hours on days 1-5 and cisplatin IV over 1 hour on days 1-5 or on day 2 Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity Patients also undergo radiotherapy twice daily on days 1-5 and 22-26 or once daily 5 days a week for 4½ weeks Patients achieving complete or partial response are randomized to 1 of 2 treatment arms
Arm I Patients undergo surgery Patients may receive 1 course of adjuvant chemotherapy as in induction therapy and undergo additional radiotherapy
Arm II Patients receive additional fluoroucacil and cisplatin as in induction therapy Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity Patients also undergo additional radiotherapy once daily 5 days a week for 2 weeks
Quality of life is assessed at baseline after treatment on arms I or II and then every 2 months arm I or every 6 months arm II thereafter
After completion of study therapy patients are followed periodically
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Compare the survival of patients with locally advanced esophageal cancer treated with neoadjuvant radiotherapy and chemotherapy comprising fluorouracil and cisplatin followed by surgery or radiotherapy and chemotherapy
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to gender histology epidermoid vs glandular response to induction therapy complete vs partial and tumor differentiation little differentiated vs undifferentiatedgood vs moderately differentiated
Induction therapy All patients receive induction therapy comprising fluorouracil IV continuously over 24 hours on days 1-5 and cisplatin IV over 1 hour on days 1-5 or on day 2 Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity Patients also undergo radiotherapy twice daily on days 1-5 and 22-26 or once daily 5 days a week for 4½ weeks Patients achieving complete or partial response are randomized to 1 of 2 treatment arms
Arm I Patients undergo surgery Patients may receive 1 course of adjuvant chemotherapy as in induction therapy and undergo additional radiotherapy
Arm II Patients receive additional fluoroucacil and cisplatin as in induction therapy Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity Patients also undergo additional radiotherapy once daily 5 days a week for 2 weeks
Quality of life is assessed at baseline after treatment on arms I or II and then every 2 months arm I or every 6 months arm II thereafter
After completion of study therapy patients are followed periodically
PROJECTED ACCRUAL A total of 40 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 |
|---|---|---|---|
| ESSAI-FFCD-9102 | None | None | None |
| FFCD-9102 | None | None | None |
| EU-20539 | None | None | None |