Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047112
Status:
COMPLETED
Last Update Posted:
2020-03-30
First Post:
2002-10-03
Brief Title:
Surgery With or Without Radiation Therapy and Chemotherapy in Treating Patients With Esophageal Cancer
Sponsor:
Federation Francophone de Cancerologie Digestive
Organization:
Federation Francophone de Cancerologie Digestive
Study Overview
Official Title:
Randomized Study of Pre-Operative Radio-Chemotherapy Versus Surgery Alone in Thoracic Esophageal Cancer Deemed to be Resectable
Status:
COMPLETED
Status Verified Date:
2020-03
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 Giving combination chemotherapy with radiation therapy before surgery may shrink the tumor so it can be removed during surgery It is not yet known if surgery is more effective with or without radiation therapy and chemotherapy in treating esophageal cancer
PURPOSE Randomized phase III trial to compare the effectiveness of surgery with or without radiation therapy and chemotherapy in treating patients who have esophageal cancer
PURPOSE Randomized phase III trial to compare the effectiveness of surgery with or without radiation therapy and chemotherapy in treating patients who have esophageal cancer
Detailed Description:
OBJECTIVES
Compare the overall survival of patients with resectable thoracic esophageal cancer treated with neoadjuvant radio-chemotherapy and surgery versus surgery alone
Compare the disease-free survival of patients treated with these regimens
Compare the surgical mortality and morbidity of patients treated with these regimens
Compare the resectability of patients treated with these regimens
Determine the validation of new prognostic factors for survival of these patients andor the efficacy of this neoadjuvant treatment
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to histology epidermoid carcinoma vs adenocarcinoma vs undifferentiated carcinoma stage I vs IIA vs IIB tumor location above the carina vs below the carina and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo radiotherapy daily 5 days a week for 5 weeks Patients receive fluorouracil IV continuously on days 1-4 and 29-32 and cisplatin IV on days 1 or 2 and 29 or 30 or a lower dose on days 1-5 and 29-33 Within 4-8 weeks after completion of radio-chemotherapy patients undergo surgical resection
Arm II Patients undergo surgical resection Patients are followed every 4 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 380 patients 190 per treatment arm will be accrued for this study within 3 years
Compare the overall survival of patients with resectable thoracic esophageal cancer treated with neoadjuvant radio-chemotherapy and surgery versus surgery alone
Compare the disease-free survival of patients treated with these regimens
Compare the surgical mortality and morbidity of patients treated with these regimens
Compare the resectability of patients treated with these regimens
Determine the validation of new prognostic factors for survival of these patients andor the efficacy of this neoadjuvant treatment
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to histology epidermoid carcinoma vs adenocarcinoma vs undifferentiated carcinoma stage I vs IIA vs IIB tumor location above the carina vs below the carina and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo radiotherapy daily 5 days a week for 5 weeks Patients receive fluorouracil IV continuously on days 1-4 and 29-32 and cisplatin IV on days 1 or 2 and 29 or 30 or a lower dose on days 1-5 and 29-33 Within 4-8 weeks after completion of radio-chemotherapy patients undergo surgical resection
Arm II Patients undergo surgical resection Patients are followed every 4 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 380 patients 190 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-20215 | None | None | None |
| FFCD-9901 | None | None | None |
| EORTC-22001 | None | None | None |
| EORTC-40001 | None | None | None |
| FRE-FNCLCC-FFCD-9901 | None | None | None |
| FRE-GERCOR-FFCD-9901 | None | None | None |
| SFRO-FFCD-9901 | None | None | None |