Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002884
Status:
UNKNOWN
Last Update Posted:
2013-08-07
First Post:
1999-11-01
Brief Title:
Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus
Sponsor:
Centre Hospitalier Lyon Sud
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A PROSPECTIVE RANDOMISED NON SURGICAL TREATMENT OF OESOPHAGEAL CANCER WITH COMBINED CHEMOTHERAPY AND EXTERNAL BEAM IRRADIATION WITH VS WITHOUT HIGH-DOSE BRACHYTHERAPY
Status:
UNKNOWN
Status Verified Date:
2007-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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 It is not yet known whether external-beam radiation therapy plus chemotherapy is more effective with or without internal radiation therapy
PURPOSE Randomized phase III trial to compare chemotherapy and external-beam radiation therapy with or without internal radiation therapy in treating patients with stage I stage II or stage III esophageal cancer
PURPOSE Randomized phase III trial to compare chemotherapy and external-beam radiation therapy with or without internal radiation therapy in treating patients with stage I stage II or stage III esophageal cancer
Detailed Description:
OBJECTIVES I Compare the complete local remission rate in patients with unresectable stage I II or III esophageal cancer treated with chemoradiotherapy with or without endoluminal brachytherapy II Compare the complete remission rate local locoregional and distant in these patients III Compare the overall and disease-free survival in these patients at 2 and 5 years after therapy IV Compare the toxicity and quality of life experienced by these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center tumor stage and chemotherapy All patients receive fluorouracil IV continuously over 4 days days 1-4 andor cisplatin on day 2 of weeks 1 and 5 External beam radiotherapy begins on day 1 of chemotherapy and is delivered in daily fractions 5 days per week for 5 weeks followed by a cone down dose administered during week 6 Patients randomized to brachytherapy Iridium 192 high-dose rate are treated on weeks 11 and 12 and receive 2 additional courses of chemotherapy at weeks 9 and 14 Patients randomized to no brachytherapy receive additional chemotherapy courses on weeks 9 and 13 Quality of life is assessed Patients are followed every 6 months for 2 years and then annually for 3 years years
PROJECTED ACCRUAL A total of 326 patients will be accrued for this study
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center tumor stage and chemotherapy All patients receive fluorouracil IV continuously over 4 days days 1-4 andor cisplatin on day 2 of weeks 1 and 5 External beam radiotherapy begins on day 1 of chemotherapy and is delivered in daily fractions 5 days per week for 5 weeks followed by a cone down dose administered during week 6 Patients randomized to brachytherapy Iridium 192 high-dose rate are treated on weeks 11 and 12 and receive 2 additional courses of chemotherapy at weeks 9 and 14 Patients randomized to no brachytherapy receive additional chemotherapy courses on weeks 9 and 13 Quality of life is assessed Patients are followed every 6 months for 2 years and then annually for 3 years years
PROJECTED ACCRUAL A total of 326 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 |
|---|---|---|---|
| EU-96013 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000065193 | REGISTRY | None | None |