Adjuvant treatment with 5-fluorouracil and folinic acid with or without irinotecan in patients with Dukes B2 or C colon cancer.

Conditions

None listed

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).

Papadimitriou CA, Papakostas P, Karina M, Malettou L, Dimopoulos MA, Pentheroudakis G, Samantas E, Bamias A, Miliaras D, Basdanis G, Xiros N, Klouvas G, Bafaloukos D, Kafiri G, Papaspirou I, Pectasides D, Karanikiotis C, Economopoulos T, Efstratiou I, Korantzis I, Pisanidis N, Makatsoris T, Matsiakou F, Aravantinos G, Kalofonos HP, Fountzilas G.

2011-01-3130 citations

10.1186/1741-7015-9-10

Interventions

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 intoler

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.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

No

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.

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

Outcome results