- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01157806
Palliative Radiochemotherapy Against Palliative Surgery in Stage IV Rectal Cancer With Unresectable Metastases
February 14, 2011 updated by: Maria Sklodowska-Curie National Research Institute of Oncology
Palliative Radiotherapy Followed by Chemotherapy Against Palliative Surgery in Patients With Rectal Cancer With Unresectable Synchronous Distant Metastases
Short course palliative radiotherapy (5x5Gy)to the pelvis in patients with symptomatic rectal tumours and with unresectable metastases may prevent palliative surgery with a good palliative outcome.The consolidating chemotherapy of XELOX may increase the efficacy of irradiation.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Patients with symptomatic rectal cancer and unresectable metastases receive 25 Gy in 5 fractions of 5 Gy over 5 days to the pelvis and XELOX consolidating chemotherapy after one week.
Investigators arbitrarily assumed that palliative radiotherapy to the pelvis can replace the immediate surgery if at least 30% of patients would avoid delayed surgery until the end of their lives, or for at least 18 months in the case of long-term survival.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: : Krzysztof Bujko, Prof.
- Phone Number: +48226439287
- Email: bujko@coi.waw.pl
Study Locations
-
-
-
Warsaw, Poland, 02-781
- Recruiting
- M. Sklodowska-Curie Memorial Cancer Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically confirmed primary carcinoma of the rectum (Lower border of tumour ≤ 10 cm from anal verge)
- Occurrence of subjective clinical symptoms of the primary tumor
- Non-resectable synchronous distant metastases. The decision of non-resectable metastases will be made at multidisciplinary clinical meetings.
Exclusion Criteria:
- Obstruction of the gastrointestinal tract
- Previously constructed stoma
- prior radiotherapy of the pelvis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: radiochemotherapy instead of surgery
|
5x5 Gy + XELOX 7 days after radiotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
percentage of patients not requiring palliative surgery during the follow-up
Time Frame: every three months
|
every three months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The rate of early toxicity of radiotherapy according to the NCI CTCAE (version 3.0)
Time Frame: 3 months
|
Assess prospectively by filling forms.
|
3 months
|
Palliative effect of radiotherapy
Time Frame: every three months
|
Assessment of radiochemotherpy effectivenes by patients using questionaire.
|
every three months
|
Time from palliative radiotherapy to delayed palliative surgery
Time Frame: 18 months
|
18 months
|
|
Determination of prognostic factors indicating the need for immediate palliative surgery.
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Krzysztof Bujko, Prof., M. Sklodowska-Curie Memorial Cancer Centre Warsaw, Poland
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Anticipated)
December 1, 2010
Study Completion (Anticipated)
June 1, 2012
Study Registration Dates
First Submitted
July 6, 2010
First Submitted That Met QC Criteria
July 6, 2010
First Posted (Estimate)
July 7, 2010
Study Record Updates
Last Update Posted (Estimate)
February 16, 2011
Last Update Submitted That Met QC Criteria
February 14, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0109
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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