Condition category
Cancer
Date applied
09/06/2004
Date assigned
27/09/2004
Last edited
17/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Gabriela Möslein

ORCID ID

Contact details

Klink für Allgemeine und Viszeralchirurgie
Universitätsklinikum Düsseldorf
Düsseldorf
40225
Germany
+49 (0)211/81-16397
moeslein@uni-duesseldorf.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

70-2993 Oh 1

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

HNPCC-associated colorectal carcinoma

Intervention

Subtotal colectomy vs. oncologic resection (restorative proctocolectomy vs rectum resection/extirpation)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2002

Overall trial end date

31/12/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Colorectal carcinoma fulfilling the Amsterdam-criteria for HNPCC or
2. Colorectal carcinoma in patients with known pathogenic mismatch repair gene mutation or
3. Colorectal carcinoma at the age of 50 or less and detection of microsatellite instability in a tumor biopsy and
4. Age between 18 and 65 years
5. Operability for subtotal colectomy/(restorative) proctocolectomy as estimated by the surgeon
6. Exclusion of metastases, local resection of the complete tumor likely to be possible
7. Elective tumorsurgical operation
8. Willingness of the patient to participate in surveillance required by the trial
9. Informed consent

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2002

Recruitment end date

31/12/2004

Locations

Countries of recruitment

Germany

Trial participating centre

Klink für Allgemeine und Viszeralchirurgie
Düsseldorf
40225
Germany

Sponsor information

Organisation

Deutsche Krebshilfe e. V. - German Cancer Aid (Germany)

Sponsor details

Thomas-Mann-Strasse 40
Bonn
53004
Germany
+49 (0)228/72990-0
deutsche@krebshilfe.de

Sponsor type

Charity

Website

http://www.krebshilfe.de/startseite-dkh.html

Funders

Funder type

Charity

Funder name

Deutsche Krebshilfe e. V. (70-2993 Oh 1)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes