NCT00259363

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 29, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Last Updated

December 7, 2009

Status Verified

December 1, 2009

Enrollment Period

3.7 years

First QC Date

November 28, 2005

Last Update Submit

December 4, 2009

Conditions

Rectal Neoplasms

Outcome Measures

Primary Outcomes (2)

  • Phase I : Maximum Tolerated Dose & Recommended Dose

    Days 1, 15, 29

  • Phase II : Response and resectability rate.

    6 cycles in 6 months

Interventions

OxaliplatinDRUG

oxaliplatin 60/mg/m2/15 days, 5-FU 225 mg/m2/day 5 weeks during radiotherapy (RT) 45 Gys/25 days

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ECOG: 0-2
  • Histological proved rectal adenocarcinoma
  • No previous pelvic radiotherapy treatment

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Barcelona, Spain

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Oxaliplatin

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Officials

  • José Mª Taboada

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 28, 2005

First Posted

November 29, 2005

Study Start

October 1, 2002

Primary Completion

June 1, 2006

Last Updated

December 7, 2009

Record last verified: 2009-12

Locations

ES(1)