Preoperative Chemoradiation Versus Short Term Radiation Alone With Delayed Surgery for Stage II and III Resectable Rectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2008 by Kaunas University of Medicine. Recruitment status was Recruiting

First Received on January 9, 2008. No Changes Posted

Sponsor:	Kaunas University of Medicine
Information provided by:	Kaunas University of Medicine
ClinicalTrials.gov Identifier:	NCT00597311

Purpose

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.

Condition	Intervention	Phase
Primary Rectal Cancer	Radiation: radiotherapy	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Preoperative Chemoradiation Versus Short Term Radiation Alone With Delayed Surgery for Stage II and III Resectable Rectal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Kaunas University of Medicine:

Primary Outcome Measures:

5 years overall and disease free survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
recurrence rate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

pathological "complete response" and downstaging rates [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Impact on sphincter sparing operation rates [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
morbidity and mortality rates [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Impact on quality of surgical resection [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	January 2007
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 preoperative short term radiation group 5x5 Gy and surgery after 6 weeks	Radiation: radiotherapy Short term radiotherapy 5x5 Gy during 5 days Chemoradiotherapy 50 Gy + 5Fu/Lv
Experimental: 2 preoperative chemoradiotherapy group 50Gy + 5FU/Lv and surgery after 6 weeks.	Radiation: radiotherapy Short term radiotherapy 5x5 Gy during 5 days Chemoradiotherapy 50 Gy + 5Fu/Lv

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00597311

Contacts

Contact: Tadas Latkauskas

+370 676 08901

tadas.latkauskas@kmuk.lt

Locations

Lithuania
KMUH, surgery department	Recruiting
Kaunas, Lithuania, LT3000
Contact: Tadas Latkauskas +370 676 08901 tadas.latkauskas@kmuk.lt

Sponsors and Collaborators

Kaunas University of Medicine

Investigators

Principal Investigator:

Dainius Pavalkis, professor

Kaunas Medical University

More Information

No publications provided

Responsible Party:	Tadas Latkauskas, Kaunas University of Medicine
ClinicalTrials.gov Identifier:	NCT00597311 History of Changes
Other Study ID Numbers:	BE-2-48, 137/2006
Study First Received:	January 9, 2008
Last Updated:	January 9, 2008
Health Authority:	Lithuania: Kaunas University of Medicine

Keywords provided by Kaunas University of Medicine:

rectal cancer
radiotherapy
radiochemotherapy

Additional relevant MeSH terms:

Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site

Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on February 09, 2012