NCT00403624

Brief Summary

Primary objective: \- To evaluate the rate of responses to neoadjuvant therapy + radiotherapy Secondary objective: \- tolerability (toxicity) and time to progression

Trial Health

100
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2001

Longer than P75 for phase_1

Status
completed

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

July 1, 2001

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 27, 2006

Completed
Last Updated

August 27, 2010

Status Verified

April 1, 2008

Enrollment Period

4.3 years

First QC Date

November 23, 2006

Last Update Submit

August 26, 2010

Conditions

Rectal Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Tumour response

Secondary Outcomes (1)

  • Disease free and Overall survival ; Adverse events

Interventions

OXALIPLATINDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with measurable, histologically proven rectal cancer.
  • No history of previous malignancy but adequately treated skin / cervical cancer.
  • Adequate haematological, renal and liver function.

You may not qualify if:

  • No cardiopulmonary insufficiency or coronary disease. No sensory neuropathy prior to study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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, Dr.

    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 23, 2006

First Posted

November 27, 2006

Study Start

July 1, 2001

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

August 27, 2010

Record last verified: 2008-04