Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086996
Status:
COMPLETED
Last Update Posted:
2013-10-11
First Post:
2004-07-08
Brief Title:
S0356 Oxaliplatin 5-FU Radiation Therapy RT Surgery for Pts With Stage II or III Cancer of Esophagus or Gastroesophageal GE Junction
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Oxaliplatin NSC-266046 Plus Protracted Infusion 5-Fluorouracil And Radiation For Potentially Curable Esophageal Cancer A Phase II Trial With Molecular Correlates
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
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 oxaliplatin and fluorouracil work in 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 Oxaliplatin and fluorouracil may make tumor cells more sensitive to radiation therapy and may kill more tumor cells Giving chemotherapy and radiation therapy before surgery may shrink the tumor so that it can be removed
PURPOSE This phase II trial is studying how well giving oxaliplatin together with fluorouracil and radiation therapy works in treating patients who are undergoing surgery for stage II or stage III cancer of the esophagus or gastroesophageal junction
PURPOSE This phase II trial is studying how well giving oxaliplatin together with fluorouracil and radiation therapy works in treating patients who are undergoing surgery for stage II or stage III cancer of the esophagus or gastroesophageal junction
Detailed Description:
OBJECTIVES
Primary
Determine the pathologic complete response probability in patients with stage II or III adenocarcinoma of the esophagus or gastroesophageal junction treated with neoadjuvant oxaliplatin fluorouracil and radiotherapy followed by definitive surgical resection
Secondary
Determine the frequency and severity of toxic effects associated with this neoadjuvant regimen in these patients
Determine the overall survival and progression-free survival of patients treated with this regimen
Exploratory Analyses subject to funding availability
Correlate preliminarily initial messenger ribonucleic acid mRNA levels of the genes for thymidylate synthase TS γ-glutamyl transpeptidase γGT γ-glutamyl cysteine γ-GCS DNA excision repair cross-complementing ERCC-1 and xeroderma pigmentosum XPA with response and survival of patients treated with this regimen
Correlate preliminarily the mRNA levels of TS γGT γ-GCS ERCC-1 and XPA before and after treatment with this regimen with survival of these patients
Correlate preliminarily specific genetic polymorphisms of TS and ERCC-1 with tumor response and overall survival of patients treated with this regimen
OUTLINE This is a multicenter study
Neoadjuvant chemoradiotherapy Patients receive oxaliplatin IV over 2 hours on days 1 15 and 29 and fluorouracil 5-FU IV continuously on days 8-43 Beginning on day 8 patients also undergo radiotherapy once daily 5 days a week for 5 weeks
Surgery Patients with stable disease or better undergo surgical resection 4-10 weeks after completion of chemoradiotherapy
Adjuvant chemotherapy Beginning 4-10 weeks after surgery patients receive chemotherapy comprising oxaliplatin IV over 2 hours on days 1 15 and 29 and 5-FU IV continuously on days 1-36
Treatment continues in the absence of unacceptable toxicity or disease progression
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 45-85 patients will be accrued for this study within 17-21 months
Primary
Determine the pathologic complete response probability in patients with stage II or III adenocarcinoma of the esophagus or gastroesophageal junction treated with neoadjuvant oxaliplatin fluorouracil and radiotherapy followed by definitive surgical resection
Secondary
Determine the frequency and severity of toxic effects associated with this neoadjuvant regimen in these patients
Determine the overall survival and progression-free survival of patients treated with this regimen
Exploratory Analyses subject to funding availability
Correlate preliminarily initial messenger ribonucleic acid mRNA levels of the genes for thymidylate synthase TS γ-glutamyl transpeptidase γGT γ-glutamyl cysteine γ-GCS DNA excision repair cross-complementing ERCC-1 and xeroderma pigmentosum XPA with response and survival of patients treated with this regimen
Correlate preliminarily the mRNA levels of TS γGT γ-GCS ERCC-1 and XPA before and after treatment with this regimen with survival of these patients
Correlate preliminarily specific genetic polymorphisms of TS and ERCC-1 with tumor response and overall survival of patients treated with this regimen
OUTLINE This is a multicenter study
Neoadjuvant chemoradiotherapy Patients receive oxaliplatin IV over 2 hours on days 1 15 and 29 and fluorouracil 5-FU IV continuously on days 8-43 Beginning on day 8 patients also undergo radiotherapy once daily 5 days a week for 5 weeks
Surgery Patients with stable disease or better undergo surgical resection 4-10 weeks after completion of chemoradiotherapy
Adjuvant chemotherapy Beginning 4-10 weeks after surgery patients receive chemotherapy comprising oxaliplatin IV over 2 hours on days 1 15 and 29 and 5-FU IV continuously on days 1-36
Treatment continues in the absence of unacceptable toxicity or disease progression
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 45-85 patients will be accrued for this study within 17-21 months
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 |
|---|---|---|---|
| U10CA032102 | NIH | None | None |
| S0356 | OTHER | SWOG | httpsreporternihgovquickSearchU10CA032102 |