Preoperative Chemoradiation Versus Short Term Radiation Alone With Delayed Surgery for Stage II and III Resectable Rectal Cancer
NCT ID: NCT00597311
Last Updated: 2008-01-18
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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UNKNOWN
PHASE3
150 participants
INTERVENTIONAL
2007-01-31
2012-01-31
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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1
preoperative short term radiation group 5x5 Gy and surgery after 6 weeks
radiotherapy
1. Short term radiotherapy 5x5 Gy during 5 days
2. Chemoradiotherapy 50 Gy + 5Fu/Lv
2
preoperative chemoradiotherapy group 50Gy + 5FU/Lv and surgery after 6 weeks.
radiotherapy
1. Short term radiotherapy 5x5 Gy during 5 days
2. Chemoradiotherapy 50 Gy + 5Fu/Lv
Interventions
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radiotherapy
1. Short term radiotherapy 5x5 Gy during 5 days
2. Chemoradiotherapy 50 Gy + 5Fu/Lv
Eligibility Criteria
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Inclusion Criteria
* less than 80 years old
* no other cancer during 5 years period
* compensate cardiovascular, pulmonary, hepatic and renal functions.
Exclusion Criteria
* other cancer in 5 years period
* radiotherapy or chemotherapy in anamnesis
* not compensate cardiovascular, pulmonary, hepatic or renal functions, neurological, psychiatric disease, sepsis, etc.
* pregnancy or baby feeding
18 Years
80 Years
ALL
No
Sponsors
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Kaunas University of Medicine
OTHER
Responsible Party
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Kaunas University of Medicine
Principal Investigators
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Dainius Pavalkis, professor
Role: PRINCIPAL_INVESTIGATOR
Kaunas Medical University
Locations
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KMUH, surgery department
Kaunas, , Lithuania
Countries
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Central Contacts
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Facility Contacts
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References
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Latkauskas T, Pauzas H, Kairevice L, Petrauskas A, Saladzinskas Z, Janciauskiene R, Gudaityte J, Lizdenis P, Svagzdys S, Tamelis A, Pavalkis D. Preoperative conventional chemoradiotherapy versus short-course radiotherapy with delayed surgery for rectal cancer: results of a randomized controlled trial. BMC Cancer. 2016 Dec 1;16(1):927. doi: 10.1186/s12885-016-2959-9.
Other Identifiers
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137/2006
Identifier Type: -
Identifier Source: secondary_id
BE-2-48
Identifier Type: -
Identifier Source: org_study_id
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