Back to resultsPreoperative Chemoradiation Versus Short Term Radiation Alone With Delayed Surgery for Stage II and III Resectable Rectal Cancer
Primary Purpose
Primary Rectal Cancer
Status
Unknown status
Phase
Phase 3
Locations
Lithuania
Study Type
Interventional
Intervention
radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Primary Rectal Cancer focused on measuring rectal cancer, radiotherapy, radiochemotherapy
Eligibility Criteria
Inclusion Criteria:
- histologically confirmed stage II and III rectal cancer less than 15 cm from anal verge
- less than 80 years old
- no other cancer during 5 years period
- compensate cardiovascular, pulmonary, hepatic and renal functions.
Exclusion Criteria:
- stage I or IV rectal cancer
- 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
Sites / Locations
- KMUH, surgery departmentRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
preoperative short term radiation group 5x5 Gy and surgery after 6 weeks
preoperative chemoradiotherapy group 50Gy + 5FU/Lv and surgery after 6 weeks.
Outcomes
Primary Outcome Measures
5 years overall and disease free survival
recurrence rate
Secondary Outcome Measures
pathological "complete response" and downstaging rates
Impact on sphincter sparing operation rates
morbidity and mortality rates
Impact on quality of surgical resection
Full Information
NCT ID
NCT00597311
First Posted
January 9, 2008
Last Updated
January 9, 2008
Sponsor
Kaunas University of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00597311
Brief Title
Preoperative Chemoradiation Versus Short Term Radiation Alone With Delayed Surgery for Stage II and III Resectable Rectal Cancer
Official Title
Preoperative Chemoradiation Versus Short Term Radiation Alone With Delayed Surgery for Stage II and III Resectable Rectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
January 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Kaunas University of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Trial compares two preoperative stage II and III rectal cancer treatment strategies: short term radiotherapy 5x5 Gy and delayed surgery after 6 weeks versus conventional chemoradiotherapy 50 Gy + 5Fu/Lv and surgery also after 6 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Rectal Cancer
Keywords
rectal cancer, radiotherapy, radiochemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
preoperative short term radiation group 5x5 Gy and surgery after 6 weeks
Arm Title
2
Arm Type
Experimental
Arm Description
preoperative chemoradiotherapy group 50Gy + 5FU/Lv and surgery after 6 weeks.
Intervention Type
Radiation
Intervention Name(s)
radiotherapy
Intervention Description
Short term radiotherapy 5x5 Gy during 5 days
Chemoradiotherapy 50 Gy + 5Fu/Lv
Primary Outcome Measure Information:
Title
5 years overall and disease free survival
Time Frame
5 years
Title
recurrence rate
Time Frame
5 years
Secondary Outcome Measure Information:
Title
pathological "complete response" and downstaging rates
Time Frame
5 years
Title
Impact on sphincter sparing operation rates
Time Frame
5 years
Title
morbidity and mortality rates
Time Frame
5 years
Title
Impact on quality of surgical resection
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
histologically confirmed stage II and III rectal cancer less than 15 cm from anal verge
less than 80 years old
no other cancer during 5 years period
compensate cardiovascular, pulmonary, hepatic and renal functions.
Exclusion Criteria:
stage I or IV rectal cancer
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tadas Latkauskas
Phone
+370 676 08901
Email
tadas.latkauskas@kmuk.lt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dainius Pavalkis, professor
Organizational Affiliation
Kaunas Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
KMUH, surgery department
City
Kaunas
ZIP/Postal Code
LT3000
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tadas Latkauskas
Phone
+370 676 08901
Email
tadas.latkauskas@kmuk.lt
12. IPD Sharing Statement
Citations:
PubMed Identifier
27903247
Citation
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.
Results Reference
derived
Learn more about this trial
Preoperative Chemoradiation Versus Short Term Radiation Alone With Delayed Surgery for Stage II and III Resectable Rectal Cancer
We'll reach out to this number within 24 hrs