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

Primary Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00597311
• Other study ID #: BE-2-48
• Secondary ID: 137/2006
• Status: Recruiting
• Phase: Phase 3
• First received: January 9, 2008
• Last updated: January 9, 2008
• Start date: January 2007
• Est. completion date: January 2012

Study information

• Verified date: January 2008
• Source: Kaunas University of Medicine
• Contact: Tadas Latkauskas
• Phone: +370 676 08901
• Email: tadas.latkauskas[@]kmuk.lt
• Is FDA regulated: No
• Health authority: Lithuania: Kaunas University of Medicine
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Primary Rectal Cancer
• Rectal Neoplasms

Intervention

Radiation:
• radiotherapy
Short term radiotherapy 5x5 Gy during 5 days Chemoradiotherapy 50 Gy + 5Fu/Lv

Locations

Country	Name	City	State
Lithuania	KMUH, surgery department	Kaunas

Sponsors (1)

Lead Sponsor	Collaborator
Kaunas University of Medicine

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5 years overall and disease free survival		5 years	Yes
Primary	recurrence rate		5 years	Yes
Secondary	pathological "complete response" and downstaging rates		5 years	Yes
Secondary	Impact on sphincter sparing operation rates		5 years	Yes
Secondary	morbidity and mortality rates		5 years	Yes
Secondary	Impact on quality of surgical resection		5 years	Yes