Watchful Waiting. An Observational Study of Patients With Rectal Cancer After Concomitant Radiation and Chemotherapy
A Prospective Observational Study of Patients With Rectal Cancer After Concomitant Radiation and Chemotherapy
1 other identifier
observational
55
1 country
1
Brief Summary
The purpose of this study is to investigate if operation and permanent stoma can be omitted in patients with cancer in the lower part of the rectum.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2009
Longer than P75 for all trials
1 active site
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
First Submitted
Initial submission to the registry
August 3, 2009
CompletedFirst Posted
Study publicly available on registry
August 6, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedFebruary 5, 2020
January 1, 2019
4.3 years
August 3, 2009
February 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of local recurrence
1 year
Secondary Outcomes (3)
Frequency of cumulative local recurrence
Up to 5 years
Frequency of distant metastases verified by planned PET/CT scans
Up to 5 years.
Overall survival
Up to 5 years.
Eligibility Criteria
Patients referred from surgical departments in Denmark.
You may qualify if:
- Histopathologically verified adenocarcinoma in the rectum
- Planned APR or ultra low resection
- Primary resectable T2 or T3 tumor
- Distance from anus to lower edge of tumor ≤ 6 cm
- Suited for curative intended radiation and chemotherapy
- Accept taking of biopsy and blood samples for translational research
- Age ≥ 18 years
- Normal function of bone marrow
- leukocytes ≥ 3 x 10\^9/l
- thrombocytes ≥ 100
- Normal liver function
- ALAT \< 2.5 x upper normal value
- bilirubin \< 2.5 x upper normal value
- Renal function
- Serum creatinin \< 1.5 x upper normal value
- +1 more criteria
You may not qualify if:
- Other malignant disease within the last 5 years apart from basocellular skin cancer and carcinoma in situ cervicis uteri
- Distant metastases
- Pregnant or breast feeding patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vejle Hospitallead
Study Sites (1)
Vejle Hospital
Vejle, DK-7100, Denmark
Related Publications (1)
Appelt AL, Ploen J, Harling H, Jensen FS, Jensen LH, Jorgensen JC, Lindebjerg J, Rafaelsen SR, Jakobsen A. High-dose chemoradiotherapy and watchful waiting for distal rectal cancer: a prospective observational study. Lancet Oncol. 2015 Aug;16(8):919-27. doi: 10.1016/S1470-2045(15)00120-5. Epub 2015 Jul 5.
PMID: 26156652DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anders Jakobsen, DMSc
Vejle Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2009
First Posted
August 6, 2009
Study Start
October 1, 2009
Primary Completion
January 1, 2014
Study Completion
December 1, 2019
Last Updated
February 5, 2020
Record last verified: 2019-01