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

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ClinicalTrials.gov Identifier: NCT00597311
Recruitment Status : Unknown
Verified January 2008 by Kaunas University of Medicine.
Recruitment status was:  Recruiting
First Posted : January 18, 2008
Last Update Posted : January 18, 2008
Sponsor:
Information provided by:
Kaunas University of Medicine

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.

Condition or disease Intervention/treatment Phase
Primary Rectal Cancer Radiation: radiotherapy Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2007
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : January 2012

Arm Intervention/treatment
Experimental: 1
preoperative short term radiation group 5x5 Gy and surgery after 6 weeks
Radiation: radiotherapy
  1. Short term radiotherapy 5x5 Gy during 5 days
  2. Chemoradiotherapy 50 Gy + 5Fu/Lv

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




Primary Outcome Measures :
  1. 5 years overall and disease free survival [ Time Frame: 5 years ]
  2. recurrence rate [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. pathological "complete response" and downstaging rates [ Time Frame: 5 years ]
  2. Impact on sphincter sparing operation rates [ Time Frame: 5 years ]
  3. morbidity and mortality rates [ Time Frame: 5 years ]
  4. Impact on quality of surgical resection [ Time Frame: 5 years ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tadas Latkauskas, Kaunas University of Medicine
ClinicalTrials.gov Identifier: NCT00597311     History of Changes
Other Study ID Numbers: BE-2-48
137/2006
First Posted: January 18, 2008    Key Record Dates
Last Update Posted: January 18, 2008
Last Verified: January 2008

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