Study of LV5FU2 Versus FOLFOX for Curatively-resected, No... | NCT01467921

Studies
Study of LV5FU2 Versus FOLFOX for Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma

NCT01467921

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Nov 16, 2011Estimated

Enrollment

68Estimated

Phase

Phase 2

Conditions

Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma

Interventions

oxaliplatin

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Feb 2012Estimated

Completion Date

Not provided

First Submitted Date

Nov 6, 2011

First Submission Date that Met QC Criteria

Nov 8, 2011

First Posted Date

Nov 9, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2011

Last Update Posted Date

Nov 16, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Oxaliplatin is a platinum analogue that has significant antitumor activity with better tolerability than cisplatin. The objective of the study is to evaluate the safety and activity of leucovorin and 5-fluorouracil and leucovorin and 5-fluorouracil plus oxaliplatin combination chemotherapy given as adjuvant therapy for curatively-resected, node-positive esophageal cancer.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

68Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LV5FU2	Active Comparator	leucovorin 200 mg/m2 and 5-fluorouracil 400 mg/m2 intravenously on day 1, followed by a 46-h protracted infusion of 5-fluorouracil 2,400 mg/m2	Drug: oxaliplatin
FOLFOX	Experimental	leucovorin 200 mg/m2 and 5-fluorouracil 400 mg/m2 intravenously on day 1, followed by a 46-h protracted infusion of 5-fluorouracil 2,400 mg/m2 oxaliplatin 85 mg/m2 will be given intravenously on day 1 for over 2 h	Drug: oxaliplatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oxaliplatin	Drug	oxaliplatin 85 mg/m2 will be given intravenously on day 1 for over 2 h	FOLFOX LV5FU2

Measure	Description	Time Frame
disease-free survival		36 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 20 years or older
Histologically confirmed squamous cell carcinoma of esophagus
Curatively (R0) resected, lymph node positive
ECOG performance status of 0 or 1
Restoration of oral intake >1500 kcal/d
No prior chemotherapy except for neoadjuvant ones
No prior radiotherapy within 1 month before registration
Adequate marrow, hepatic, renal and cardiac functions
Provision of a signed written informed consent

Exclusion Criteria:

Severe co-morbid illness and/or active infections
Prior treatment with oxaliplatin
Pregnant or lactating women
Active CNS metastases not controllable with radiotherapy or corticosteroids
Known history of hypersensitivity to study drugs

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
mi yeon kwon, RN	Contact	+82-2-3410-1248		miyeon.kwon@samsung.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center	Recruiting	Seoul			South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D000077150	Oxaliplatin

Ancestor Terms

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided