ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

colon cancer

Condition category

Condition code

Cancer

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]

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]

Disease-free survival (DFS)

Timepoint [1]

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]

Overall Survival (OS)

Timepoint [1]

3-year survival rate (following randomisation). This outcome is assessed using clinical data records

Secondary outcome [2]

Toxicity

Timepoint [2]

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

Sex

Both males and females

Can healthy volunteers participate?

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

8/01/1999

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

870

Accrual to date

Final

Recruitment outside Australia

Country [1]

Greece

State/province [1]

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Hellenic Cooperative Oncology Group

Address [1]

18 Hatzikostandi str, 11524 Athens

Country [1]

Greece

Primary sponsor type

Other Collaborative groups

Name

Hellenic Cooperative Oncology Group

Address

18 Hatzikostandi str, 11524 Athens

Country

Greece

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Helen Papakostaki

Address

Hellenic Cooperative Oncology Group, 18 Hatzikostandi str, 11524 Athens

Country

Greece

Phone

+302106912520

Fax

+302106912713

[email protected]

Contact person for scientific queries

Name

George Fountzilas

Address

Hellenic Cooperative Oncology Group, 18 Hatzikostandi str, 11524 Athens

Country

Greece

Phone

+302106912520

Fax

+302106912713

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	A randomized phase III trial of adjuvant chemotherapy with irinotecan, leucovorin and fluorouracil versus leucovorin and fluorouracil for stage II and III colon cancer: A Hellenic Cooperative Oncology Group study	2011	https://doi.org/10.1186/1741-7015-9-10

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically