Randomized Clinical Trial on Preoperative Radiotherapy 25 Gy in Rectal Cancer
NCT ID: NCT01444495
Last Updated: 2023-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
154 participants
INTERVENTIONAL
1999-01-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Short time interval
Patients operated on 7-10 days after completing preoperative radiotherapy 5x5Gy.
Preoperative radiotherapy
Preoperative radiotherapy 5x5 Gy (total dose of 25 Gy)
Surgery
Total mesorectal excision of rectal cancer
Long time interval
Patients operated on 4-5 weeks after completing preoperative radiotherapy 5x5Gy.
Preoperative radiotherapy
Preoperative radiotherapy 5x5 Gy (total dose of 25 Gy)
Surgery
Total mesorectal excision of rectal cancer
Interventions
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Preoperative radiotherapy
Preoperative radiotherapy 5x5 Gy (total dose of 25 Gy)
Surgery
Total mesorectal excision of rectal cancer
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* tumor localised in middle or lower rectum
* age \> 18 years
* locally advanced cancer
Exclusion Criteria
* lack of patient's consent
* lack of possibility to begin radiotherapy during 14 days after inclusion to the study
18 Years
ALL
No
Sponsors
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Jagiellonian University
OTHER
Responsible Party
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Radoslaw Pach, MD, PhD
Assisstant Professor
Principal Investigators
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Jan Kulig, Prof.
Role: STUDY_CHAIR
First Department of General Surgery, Jagiellonian University
Radoslaw Pach, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
First Department of General Surgery, Jagiellonian University
Locations
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First Department of Surgery
Krakow, Malopolska, Poland
Countries
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References
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Pach R, Kulig J, Richter P, Gach T, Szura M, Kowalska T. Randomized clinical trial on preoperative radiotherapy 25 Gy in rectal cancer--treatment results at 5-year follow-up. Langenbecks Arch Surg. 2012 Jun;397(5):801-7. doi: 10.1007/s00423-011-0890-8. Epub 2011 Dec 15.
Pach R, Kulig J, Richter P, Gach T, Szura M, Kowalska T. Erratum to: Randomized clinical trial on preoperative radiotherapy 25 Gy in rectal cancer-treatment results at 5 year follow-up. Langenbecks Arch Surg. 2019 Sep;404(Suppl 1):19-20. doi: 10.1007/s00423-012-0940-x. No abstract available.
Pach R, Sierzega M, Szczepanik A, Popiela T, Richter P. Preoperative radiotherapy 5 x 5 Gy and short versus long interval between surgery for resectable rectal cancer: 10-Year follow-up of the randomised controlled trial. Radiother Oncol. 2021 Nov;164:268-274. doi: 10.1016/j.radonc.2021.10.006. Epub 2021 Oct 13.
Pach R, Richter P, Sierzega M, Papp N, Szczepanik A. Preoperative Short-Course Radiotherapy and Surgery versus Surgery Alone for Patients with Rectal Cancer: A Propensity Score-Matched Analysis at 18-Year Follow-Up. Biomedicines. 2021 Jun 24;9(7):725. doi: 10.3390/biomedicines9070725.
Pach R, Szczepanik AM, Sierzega M, Daniluk M, Richter P. Prognostic value of lymph node ratio in resectable rectal cancer after preoperative short-course radiotherapy-results from randomized clinical trial. Langenbecks Arch Surg. 2022 Nov;407(7):2969-2980. doi: 10.1007/s00423-022-02603-8. Epub 2022 Jul 4.
Other Identifiers
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Cracow Rectal Cancer Trial
Identifier Type: -
Identifier Source: org_study_id
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