Palliative Radiochemotherapy Against Palliative Surgery in Stage IV Rectal Cancer With Unresectable Metastases
Palliative Radiotherapy Followed by Chemotherapy Against Palliative Surgery in Patients With Rectal Cancer With Unresectable Synchronous Distant Metastases
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 6, 2010
CompletedFirst Posted
Study publicly available on registry
July 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFebruary 16, 2011
February 1, 2011
11 months
July 6, 2010
February 14, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
percentage of patients not requiring palliative surgery during the follow-up
every three months
Secondary Outcomes (4)
The rate of early toxicity of radiotherapy according to the NCI CTCAE (version 3.0)
3 months
Palliative effect of radiotherapy
every three months
Time from palliative radiotherapy to delayed palliative surgery
18 months
Determination of prognostic factors indicating the need for immediate palliative surgery.
18 months
Study Arms (1)
radiochemotherapy instead of surgery
EXPERIMENTALInterventions
5x5 Gy + XELOX 7 days after radiotherapy
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Obstruction of the gastrointestinal tract
- Previously constructed stoma
- prior radiotherapy of the pelvis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
M. Sklodowska-Curie Memorial Cancer Centre
Warsaw, 02-781, Poland
Related Publications (1)
Tyc-Szczepaniak D, Wyrwicz L, Kepka L, Michalski W, Olszyna-Serementa M, Palucki J, Pietrzak L, Rutkowski A, Bujko K. Palliative radiotherapy and chemotherapy instead of surgery in symptomatic rectal cancer with synchronous unresectable metastases: a phase II study. Ann Oncol. 2013 Nov;24(11):2829-34. doi: 10.1093/annonc/mdt363. Epub 2013 Sep 6.
PMID: 24013512DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Krzysztof Bujko, Prof.
M. Sklodowska-Curie Memorial Cancer Centre Warsaw, Poland
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 6, 2010
First Posted
July 7, 2010
Study Start
January 1, 2010
Primary Completion
December 1, 2010
Study Completion
June 1, 2012
Last Updated
February 16, 2011
Record last verified: 2011-02