Oxaliplatin in Rectal Cancer | NCT00259363

Studies
Oxaliplatin in Rectal Cancer

NCT00259363

Sponsor

Sanofi

Status

Terminated

Last Update Posted

Dec 7, 2009Estimated

Enrollment

46Actual

Phase

Phase 1Phase 2

Conditions

Rectal Neoplasms

Interventions

Oxaliplatin

Countries

Spain

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

Dec 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study cancelled because recruitment rate was too slow

Expanded Access Info

Start Date

Oct 2002

Primary Completion Date

Jun 2006Actual

Completion Date

Not provided

First Submitted Date

Nov 28, 2005

First Submission Date that Met QC Criteria

Nov 28, 2005

First Posted Date

Nov 29, 2005Estimated

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

Dec 4, 2009

Last Update Posted Date

Dec 7, 2009Estimated

Description Module

Brief Summary

Phase I: To determine the maximum tolerated dose, and recommended dose of the proposed doses of oxaliplatin in this study
Phase II: To determine the treatment efficacy according to response rates from phase I.

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxaliplatin	Drug	oxaliplatin 60/mg/m2/15 days, 5-FU 225 mg/m2/day 5 weeks during radiotherapy (RT) 45 Gys/25 days

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Phase I : Maximum Tolerated Dose & Recommended Dose		Days 1, 15, 29
Phase II : Response and resectability rate.		6 cycles in 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

Main criteria are listed hereafter:

Inclusion Criteria:

ECOG: 0-2
Histological proved rectal adenocarcinoma
No chemotherapy treatment on the previous 6 months before inclusion.
No previous pelvic radiotherapy treatment

Exclusion Criteria:

Important Biological abnormality (renal, hepatic and/or hematological)
Intestinal occlusion or subocclusion
Peripheral neuropathy
Pregnant or breast-feeding women. Potential child-bearing women with a positive pregnancy test.
Participation in other trials on the previous 4 months.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
José Mª Taboada	Sanofi	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D012004	Rectal Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals