Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00425425
Status:
UNKNOWN
Last Update Posted:
2014-05-01
First Post:
2007-01-19
Brief Title:
Cetuximab Oxaliplatin Fluorouracil and Radiation Therapy in Treating Patients With Stage II or Stage III Esophageal Cancer
Sponsor:
Technical University of Munich
Organization:
Technical University of Munich
Study Overview
Official Title:
Neoadjuvant Radiochemotherapy in Local Advanced Squamous Cell Carcinoma of the Esophagus With Weekly Cetuximab Plus Oxaliplatin Plus Continuous IV 5-FU and Conventional Fractionated External Multi-Field Irradiation up to 45 Gray A Phase III Study
Status:
UNKNOWN
Status Verified Date:
2014-04
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 Monoclonal antibodies such as cetuximab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Cetuximab may also make tumor cells more sensitive to radiation therapy Drugs used in chemotherapy such as oxaliplatin and fluorouracil work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Radiation therapy uses high-energy x-rays to kill tumor cells Giving cetuximab chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed
PURPOSE This phase III trial is studying the side effects and best dose of oxaliplatin and fluorouracil when given together with cetuximab and radiation therapy and to see how well they work in treating patients with stage II or stage III esophageal cancer
PURPOSE This phase III trial is studying the side effects and best dose of oxaliplatin and fluorouracil when given together with cetuximab and radiation therapy and to see how well they work in treating patients with stage II or stage III esophageal cancer
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of oxaliplatin and fluorouracil when administered with cetuximab and radiotherapy in patients with stage II or III squamous cell carcinoma of the esophagus Phase I
Determine the response rate in patients treated with this regimen Phase II
Secondary
Determine the toxicity of this regimen in these patients
Determine the postoperative complication rate and lethality in patients treated with this regimen
Determine the R0 resection rate in patients treated with this regimen
Determine the overall survival of patients treated with this regimen
Determine the event-free survival of patients treated with this regimen
Determine the metabolic response rate in patients treated with this regimen
OUTLINE This is a phase I dose-escalation study of oxaliplatin and fluorouracil followed by an open-label phase II study
Phase I Patients receive cetuximab IV over 60-90 minutes on days -15 -8 1 8 15 22 and 29 oxaliplatin IV over 120 minutes on days 1 8 22 and 29 and fluorouracil IV continuously on days 1-5 8-12 15-19 22-26 and 29-33 Patients undergo radiotherapy on days 1-5 8-12 15-19 22-26 and 29-33 Patients then undergo radical esophagectomy 29-42 days after the completion of chemoradiotherapy
Cohorts of 3-6 patients receive escalating doses of oxaliplatin and fluorouracil until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive oxaliplatin and fluorouracil as in phase I at the MTD determined in phase I Patients also receive cetuximab and undergo radiotherapy and radical esophagectomy as in phase I
After completion of study therapy patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 43 patients will be accrued for this study
Primary
Determine the maximum tolerated dose of oxaliplatin and fluorouracil when administered with cetuximab and radiotherapy in patients with stage II or III squamous cell carcinoma of the esophagus Phase I
Determine the response rate in patients treated with this regimen Phase II
Secondary
Determine the toxicity of this regimen in these patients
Determine the postoperative complication rate and lethality in patients treated with this regimen
Determine the R0 resection rate in patients treated with this regimen
Determine the overall survival of patients treated with this regimen
Determine the event-free survival of patients treated with this regimen
Determine the metabolic response rate in patients treated with this regimen
OUTLINE This is a phase I dose-escalation study of oxaliplatin and fluorouracil followed by an open-label phase II study
Phase I Patients receive cetuximab IV over 60-90 minutes on days -15 -8 1 8 15 22 and 29 oxaliplatin IV over 120 minutes on days 1 8 22 and 29 and fluorouracil IV continuously on days 1-5 8-12 15-19 22-26 and 29-33 Patients undergo radiotherapy on days 1-5 8-12 15-19 22-26 and 29-33 Patients then undergo radical esophagectomy 29-42 days after the completion of chemoradiotherapy
Cohorts of 3-6 patients receive escalating doses of oxaliplatin and fluorouracil until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive oxaliplatin and fluorouracil as in phase I at the MTD determined in phase I Patients also receive cetuximab and undergo radiotherapy and radical esophagectomy as in phase I
After completion of study therapy patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 43 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 |
|---|---|---|---|
| EUDRACT-2006-001097-24 | None | None | None |
| KRDI-TUM-OE7-432-LOR-0033-I | None | None | None |
| EU-20658 | None | None | None |