NCT00835055

Brief Summary

The purpose of this study is to determine whether markers on tumor tissue may be an indicator for good response to neoadjuvant chemoradiotherapy in patients with rectal cancer.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

April 1, 2005

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2009

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

April 5, 2019

Status Verified

April 1, 2019

Enrollment Period

14 years

First QC Date

February 2, 2009

Last Update Submit

April 3, 2019

Conditions

Rectal Cancer

Keywords

rectal cancer with neoadjuvant treatmentstandardized clinical teststumor markers on tumor tissue

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

group is selected from a single institution ( community hospital)

You may qualify if:

  • locally advanced rectal cancer uT3 or uT4
  • no distant metastasis
  • neoadjuvant radiochemotherapy required

You may not qualify if:

  • rejection of radiochemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Claraspital, Chirurgische Klinik

Basel, 4016, Switzerland

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.med

Study Record Dates

First Submitted

February 2, 2009

First Posted

February 3, 2009

Study Start

April 1, 2005

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

April 5, 2019

Record last verified: 2019-04

Locations

CH(1)