Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00509561
Status:
UNKNOWN
Last Update Posted:
2012-12-18
First Post:
2007-07-30
Brief Title:
Cisplatin Capecitabine and Radiation Therapy With or Without Cetuximab in Treating Patients With Esophageal Cancer
Sponsor:
Wales Cancer Trials Unit
Organization:
Wales Cancer Trials Unit
Study Overview
Official Title:
A Randomised Phase IIIII Multi-Centre Clinical Trial of Definitive Chemotherapy With or Without Cetuximab in Carcinoma of the Oesophagus
Status:
UNKNOWN
Status Verified Date:
2012-12
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 such as cisplatin and capecitabine work in different ways to kill tumor cells or stop them from growing Radiation therapy uses high-energy x-rays to kill tumor cells 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 stop the growth of tumor cells by blocking some of the enzymes needed for cell growth It is not yet known whether giving cisplatin together with capecitabine and radiation therapy is more effective with or without cetuximab in treating esophageal cancer
PURPOSE This randomized phase IIIII trial is studying the side effects and how well giving cisplatin together with capecitabine radiation therapy and cetuximab works compared with giving cisplatin capecitabine and radiation therapy without cetuximab in treating patients with esophageal cancer
PURPOSE This randomized phase IIIII trial is studying the side effects and how well giving cisplatin together with capecitabine radiation therapy and cetuximab works compared with giving cisplatin capecitabine and radiation therapy without cetuximab in treating patients with esophageal cancer
Detailed Description:
OBJECTIVES
Primary
To determine whether the addition of cetuximab to definitive chemoradiotherapy comprising cisplatin capecitabine and radiotherapy shows evidence of enhanced overall survival in patients with carcinoma of the esophagus
To determine the safety of this regimen in these patients
To determine the feasibility of this regimen in these patients
OUTLINE This is a multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive cisplatin IV over 2 hours on days 1 22 43 and 64 and oral capecitabine twice daily on days 1-84 Beginning in week 7 patients also undergo radiotherapy 5 days a week for 5 weeks weeks 7-11 Treatment continues in the absence of disease progression or unacceptable toxicity
Arm II Patients receive cisplatin and capecitabine and undergo radiotherapy as in arm I Patients also receive cetuximab IV over 1-2 hours on day 1 in weeks 1-12 Treatment continues in the absence of disease progression or unacceptable toxicity
Quality of life and health economics are assessed at baseline during treatment and at pre-specified time points during follow-up
After completion of study treatment patients are followed every 3 months for 1 year every 4 months for 1 year and then annually for a minimum of 5 years
Primary
To determine whether the addition of cetuximab to definitive chemoradiotherapy comprising cisplatin capecitabine and radiotherapy shows evidence of enhanced overall survival in patients with carcinoma of the esophagus
To determine the safety of this regimen in these patients
To determine the feasibility of this regimen in these patients
OUTLINE This is a multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive cisplatin IV over 2 hours on days 1 22 43 and 64 and oral capecitabine twice daily on days 1-84 Beginning in week 7 patients also undergo radiotherapy 5 days a week for 5 weeks weeks 7-11 Treatment continues in the absence of disease progression or unacceptable toxicity
Arm II Patients receive cisplatin and capecitabine and undergo radiotherapy as in arm I Patients also receive cetuximab IV over 1-2 hours on day 1 in weeks 1-12 Treatment continues in the absence of disease progression or unacceptable toxicity
Quality of life and health economics are assessed at baseline during treatment and at pre-specified time points during follow-up
After completion of study treatment patients are followed every 3 months for 1 year every 4 months for 1 year and then annually for a minimum of 5 years
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 |
|---|---|---|---|
| WCTU-SCOPE-1 | None | None | None |
| EU-20739 | None | None | None |
| EUDRACT-2006-002241-37 | None | None | None |
| ISRCTN47718479 | None | None | None |
| CTA-178530202001-0001 | None | None | None |