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Trial registered on ANZCTR


Registration number
ACTRN12610000148077
Ethics application status
Approved
Date submitted
9/02/2010
Date registered
12/02/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Adjuvant treatment with 5-fluorouracil and folinic acid with or without irinotecan in patients with Dukes B2 or C colon cancer.
Scientific title
The effect of adjuvant treatment with 5-fluorouracil, folinic acid and irinotecan versus 5-fluorouracil and folinic acid only, on disease free survival in Dukes B2 and C colon cancer. A multicenter phase III trial
Secondary ID [1] 1396 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
colon cancer 237349 0
Condition category
Condition code
Cancer 239671 239671 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Camptothecin-11 (CPT – 11): 80 mg/m2 in 250 ml normal saline 0,9% over a 90 min infusion followed immediately by:
Folinic acid (FA): 200 mg/m2 in 500 ml normal saline 0,9% over a 120 min infusion
5-Fluorouracil (5FU): 450 mg/m2 intravenous (IV) bolus, given 60 min after initiation of FA infusion.
The regimen will be administered once weekly for 4 consecutive weeks on days 1,8,15,22 followed by a 2 – week rest period. Start next cycle on day 36, for a total of 6 treatment cycles (unless intolerable toxicity occurs, which requires discontinuation of treatment).
The treatment consists of 6 treatment cycles in total. Each cycle consists of 4 weeks of treatment followed by a 2-week rest period.
Intervention code [1] 237011 0
Treatment: Drugs
Comparator / control treatment
FA: 200 mg/m2 in 500 ml normal saline 0,9% over a 120 min infusion
5-FU: 500 mg.m2 IV bolus, given 60 min after initiation of FA infusion
The regimen will be administered once weekly for 6 consecutive weeks on days 1,8,15,22,29 and 36, followed by a 2 week rest period. Start next cycle on day 50, for a total of 4 treatment cycles (unless intolerable toxicity occurs, which requires discontinuation of treatment).
The treatment consists of 4 treatment cycles in total. Each cycle consists of 6 weeks of treatment followed by a 2-week rest period.
Control group
Active

Outcomes
Primary outcome [1] 240446 0
Disease-free survival (DFS)
Timepoint [1] 240446 0
3-year DFS rate (following randomisation). This outcome is assessed by physical examination, laboratory evaluation of hematology and biochemistry, computed tomography (CT), bone scan (if indicated), endoscopy at the end of the study
Secondary outcome [1] 244952 0
Overall Survival (OS)
Timepoint [1] 244952 0
3-year survival rate (following randomisation). This outcome is assessed using clinical data records
Secondary outcome [2] 263219 0
Toxicity
Timepoint [2] 263219 0
1 month since the last administration of the drug. Toxicity is assessed by laboratory evaluation of hematology and biochemistry, physical examination etc

Eligibility
Key inclusion criteria
Histologic proof of adenocarcinoma of the colon in who complete resection of the primary tumor has been performed with neither gross nor microscopic evidence of residual disease.
Dukes stage B or C disease.
The patient should be randomized into the study between 3 and 6 weeks postoperatively.
The patient must be willing and able to give informed consent according to the dispositions of the Helsinki convention and its Tokyo and Venice amendments.
The patient must be maintaining oral nutrition and must be ambulatory at least 50% of the day.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
White Blood Cells (WBC) less than 3,500/mm3 or platelets < 100,000mm3
Any concurrent second malignant disease or any previous malignant tumor within the previous 3 years except superficial squamous cell or basal cell carcinoma of the skin or in situ carcinoma of the cervix.
Evidence of unresected distant or regional metastasis
Pregnant or lactating women
Ambulatory less than 50% of the day.
Current history of chronic diarrhea
Other serious illness

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1917 0
Greece
State/province [1] 1917 0

Funding & Sponsors
Funding source category [1] 256213 0
Other Collaborative groups
Name [1] 256213 0
Hellenic Cooperative Oncology Group
Address [1] 256213 0
18 Hatzikostandi str, 11524 Athens
Country [1] 256213 0
Greece
Primary sponsor type
Other Collaborative groups
Name
Hellenic Cooperative Oncology Group
Address
18 Hatzikostandi str, 11524 Athens
Country
Greece
Secondary sponsor category [1] 251553 0
None
Name [1] 251553 0
Address [1] 251553 0
Country [1] 251553 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The aim of this multicenter randomized phase III trial is to compare the disease free and overall survival and to assess the toxicity profile of Dukes B2 and C colon cancer patients treated postoperatively with 5-Fluorouracil (5-FU) and folinic acid (FA) (which is considered as standard adjuvant treatment) or with a regimen including the same drugs plus irinotecan (CPT –11).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29962 0
Address 29962 0
Country 29962 0
Phone 29962 0
Fax 29962 0
Email 29962 0
Contact person for public queries
Name 13209 0
Helen Papakostaki
Address 13209 0
Hellenic Cooperative Oncology Group, 18 Hatzikostandi str, 11524 Athens
Country 13209 0
Greece
Phone 13209 0
+302106912520
Fax 13209 0
+302106912713
Email 13209 0
hecogoff@otenet.gr
Contact person for scientific queries
Name 4137 0
George Fountzilas
Address 4137 0
Hellenic Cooperative Oncology Group, 18 Hatzikostandi str, 11524 Athens
Country 4137 0
Greece
Phone 4137 0
+302106912520
Fax 4137 0
+302106912713
Email 4137 0
hecogoff@otenet.gr

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary