Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00268437
Status:
TERMINATED
Last Update Posted:
2016-07-06
First Post:
2005-12-20
Brief Title:
Radiation Therapy Pemetrexed Disodium and Carboplatin in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed By Surgery
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Trial of Preoperative Radiation and Chemotherapy Pemetrexed and Carboplatin for Locally Advanced Esophageal Cancer
Status:
TERMINATED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Trial closed early because during an interim analysis the primary endpoint fell short
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 pemetrexed disodium and carboplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Giving radiation therapy together with pemetrexed disodium and carboplatin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed
PURPOSE This phase II trial is studying how well giving radiation therapy together with pemetrexed disodium and carboplatin works in treating patients with locally advanced esophageal cancer that can be removed by surgery
PURPOSE This phase II trial is studying how well giving radiation therapy together with pemetrexed disodium and carboplatin works in treating patients with locally advanced esophageal cancer that can be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Determine the pathologic complete response rate of radiotherapy pemetrexed disodium and carboplatin when administered prior to esophagectomy in patients with locally advanced esophageal cancer
Secondary
Determine the activity in terms of clinical response rate and adverse event profile of radiotherapy pemetrexed disodium and carboplatin when administered prior to esophagectomy
Determine the overall survival time-to-progression and time-to-treatment failure for patients receiving the above combined modality treatment
Determine the surgical outcome for all patients who undergo esophagectomy
Determine the time-to-disease recurrence and disease-free survival for patients who have a curative resection
Determine quality of life of patients treated with this regimen OUTLINE This is a multicenter study Patients undergo radiotherapy once daily 5 days a week for 5 ½ weeks and concurrently receive pemetrexed disodium IV over 10 minutes and carboplatin IV over 30 minutes on days 1 and 22 Treatment continues in the absence of disease progression or unacceptable toxicity Patients who are eligible will undergo esophagectomy between 4-12 weeks after completion of radiotherapy
Quality of life is assessed at baseline immediately prior to day 22 of chemotherapy and within 2 weeks prior to surgery
After completion of study treatment patients are followed periodically for approximately 4 years
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
Primary
Determine the pathologic complete response rate of radiotherapy pemetrexed disodium and carboplatin when administered prior to esophagectomy in patients with locally advanced esophageal cancer
Secondary
Determine the activity in terms of clinical response rate and adverse event profile of radiotherapy pemetrexed disodium and carboplatin when administered prior to esophagectomy
Determine the overall survival time-to-progression and time-to-treatment failure for patients receiving the above combined modality treatment
Determine the surgical outcome for all patients who undergo esophagectomy
Determine the time-to-disease recurrence and disease-free survival for patients who have a curative resection
Determine quality of life of patients treated with this regimen OUTLINE This is a multicenter study Patients undergo radiotherapy once daily 5 days a week for 5 ½ weeks and concurrently receive pemetrexed disodium IV over 10 minutes and carboplatin IV over 30 minutes on days 1 and 22 Treatment continues in the absence of disease progression or unacceptable toxicity Patients who are eligible will undergo esophagectomy between 4-12 weeks after completion of radiotherapy
Quality of life is assessed at baseline immediately prior to day 22 of chemotherapy and within 2 weeks prior to surgery
After completion of study treatment patients are followed periodically for approximately 4 years
PROJECTED ACCRUAL A total of 50 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 |
|---|---|---|---|
| CDR0000455635 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02678 | REGISTRY | None | None |