Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00335959
Status:
TERMINATED
Last Update Posted:
2012-08-17
First Post:
2006-06-08
Brief Title:
S0425 Oxaliplatin Capecitabine and RT in Treating Patients WStomach Cancer That Can Be Removed By Surgery
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Neoadjuvant Chemoradiation Therapy With Oxaliplatin and Capecitabine for Patients With Surgically Resectable Gastric Cancer A Pilot Phase II Trial With Molecular Correlates
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closed due to slow accrual
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 oxaliplatin and capecitabine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells Radiation therapy uses high-energy x-rays to kill tumor cells Giving chemotherapy together with radiation therapy 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 oxaliplatin and capecitabine together with radiation therapy works in treating patients with stomach cancer that can be removed by surgery
PURPOSE This phase II trial is studying how well giving oxaliplatin and capecitabine together with radiation therapy works in treating patients with stomach cancer that can be removed by surgery
Detailed Description:
OBJECTIVES
Determine the pathologic complete response rate in patients with primary gastric adenocarcinoma treated with neoadjuvant chemoradiotherapy comprising oxaliplatin capecitabine and radiotherapy This will not be completed as this study was closed early due to poor accrual
Assess the frequency and severity of toxicities associated with this regimen
Explore preliminarily the association between DNA repair genes ERCC-1 XRCC1 GST-P1 XPD XPA ribonucleotide reductase target enzymes thymidylate synthase TS dihydropyrimidine dehydrogenase thymidine phosphorylase TP and angiogenic factors vascular endothelial growth factor VEGF epidermal growth factor EGF PD-ECGF basic fibroblast growth factor TSP-1 and -2 transforming growth factor TGF-β and IL-8 and response to neoadjuvant therapy in patients with adenocarcinoma of the stomach This will not be completed as this study was closed early due to poor accrual
Explore preliminarily the association of haplotypes of candidate genes of TS TP ERCC-1 XPD GST-P1 cyclooxygenase-2 EGF receptor TGF-β VEGF and IL-8 with response and toxicity to neoadjuvant chemoradiation therapy in these patients This will not be completed as this study was closed early due to poor accrual
Explore preliminarily the feasibility of performing comparative genomic hybridization for analysis of DNA copy number changes in predicting response to neoadjuvant chemoradiation therapy This will not be completed as this study was closed early due to poor accrual
OUTLINE This is a multicenter pilot study
Neoadjuvant chemotherapy Patients receive oxaliplatin IV over 2 hours on days 1 and 22 and oral capecitabine twice daily on days 1-14 and 22-35 in the absence of disease progression or unacceptable toxicity
Neoadjuvant chemoradiotherapy Patients receive oral capecitabine twice daily on days 43-77 and undergo radiotherapy once daily on days 43-47 50-54 57-61 64-68 and 71-75 in the absence of disease progression or unacceptable toxicity
Surgery Patients with stable or responding disease undergo surgery 4-6 weeks after completion of chemoradiotherapy
Tumor tissue is obtained at surgery or endoscopic biopsy Gene expression analysis and comparative genomic hybridization testing are conducted on the tissue Blood is drawn prior to beginning study treatment and is analyzed for germline polymorphisms
After completion of study treatment patients are followed periodically for up to 3 years
PROJECTED ACCRUAL A total of 75 patients will be accrued for this study
Determine the pathologic complete response rate in patients with primary gastric adenocarcinoma treated with neoadjuvant chemoradiotherapy comprising oxaliplatin capecitabine and radiotherapy This will not be completed as this study was closed early due to poor accrual
Assess the frequency and severity of toxicities associated with this regimen
Explore preliminarily the association between DNA repair genes ERCC-1 XRCC1 GST-P1 XPD XPA ribonucleotide reductase target enzymes thymidylate synthase TS dihydropyrimidine dehydrogenase thymidine phosphorylase TP and angiogenic factors vascular endothelial growth factor VEGF epidermal growth factor EGF PD-ECGF basic fibroblast growth factor TSP-1 and -2 transforming growth factor TGF-β and IL-8 and response to neoadjuvant therapy in patients with adenocarcinoma of the stomach This will not be completed as this study was closed early due to poor accrual
Explore preliminarily the association of haplotypes of candidate genes of TS TP ERCC-1 XPD GST-P1 cyclooxygenase-2 EGF receptor TGF-β VEGF and IL-8 with response and toxicity to neoadjuvant chemoradiation therapy in these patients This will not be completed as this study was closed early due to poor accrual
Explore preliminarily the feasibility of performing comparative genomic hybridization for analysis of DNA copy number changes in predicting response to neoadjuvant chemoradiation therapy This will not be completed as this study was closed early due to poor accrual
OUTLINE This is a multicenter pilot study
Neoadjuvant chemotherapy Patients receive oxaliplatin IV over 2 hours on days 1 and 22 and oral capecitabine twice daily on days 1-14 and 22-35 in the absence of disease progression or unacceptable toxicity
Neoadjuvant chemoradiotherapy Patients receive oral capecitabine twice daily on days 43-77 and undergo radiotherapy once daily on days 43-47 50-54 57-61 64-68 and 71-75 in the absence of disease progression or unacceptable toxicity
Surgery Patients with stable or responding disease undergo surgery 4-6 weeks after completion of chemoradiotherapy
Tumor tissue is obtained at surgery or endoscopic biopsy Gene expression analysis and comparative genomic hybridization testing are conducted on the tissue Blood is drawn prior to beginning study treatment and is analyzed for germline polymorphisms
After completion of study treatment patients are followed periodically for up to 3 years
PROJECTED ACCRUAL A total of 75 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 |
|---|---|---|---|
| S0425 | OTHER | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| U10CA032102 | NIH | None | None |