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
Sponsor:
Information provided by:
Kaunas University of Medicine
ClinicalTrials.gov Identifier:
NCT00597311
First received: January 9, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  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 3

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:


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
  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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014