Adjuvant therapy: colorectal cancer chemotherapy study (LIitännäishoito: Paksu- ja PeräsuoliSYövän SYtostaattiTerapiaTutkimus): comparison of 5-fluorouracil (5-FU) and leucovorin as bolus injection or continuous infusion with special emphasis on toxicity, cost-benefit, quality of life, effect of nutrition, changes in bacterial flora and prognostic factors

A comparison of 5-FU and leucovorin treatment as bolus injection or continuous infusion in the adjuvant therapy of Dukes' B, C and radically operated D colorectal cancer: a randomized phase III trial studying toxicity, cost-benefit and quality of life in bolus injection and continuous infusion treatment regimens, effects of nutrition and nutritional support, changes in bacterial flora and prognostic factors

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN98405441

Enrollment

450

Registered

2012-07-16

Start date

1997-11-07

Completion date

Unknown

Last updated

2021-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radically operated colorectal cancer Stage II-IV Cancer Malignant neoplasm of colon, rectum

Interventions

Comparison of 5-fluorouracil and leucovorin as bolus injection or continuous infusion. Secondary randomization to 1. Nutritional counselling 1/3 2. Lac

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years 2. Had histologically confirmed radically operated stage II-IV colorectal cancer (CRC) 3. WHO performance status 0 ? 2 and adequate bone marrow, kidney and liver function

Exclusion criteria

Exclusion criteria: 1. Presence of other invasive cancer than CRC in history except for adequately treated carcinoma in situ of the cervix or non-melanoma skin cancer 2. Metabolic, neurological or psychiatric illness that was incompatible with chemotherapy 3. Serious thromboembolic event currently under treatment 4. Pregnancy, lactation or absence of adequate contraception in fertile patients

Design outcomes

Primary

Measure	Time frame
1. Differences in toxicity profile, adverse events and quality of life in bolus and infusional treatment regimens. The aim is to develop a new adjuvant treatment standard that enables cytostatics in home care, and to prevent and treat side-effects efficiently. The intention is to interfere with patients' everyday life as little as possible during the 6 months of adjuvant treatment. 2. Cost-benefit differences in bolus and infusional treatment. In preliminary calculations the continuous infusion at home should be 30% cheaper than bolus treatment in the clinics. Though continuous infusion has been considered expensive, no accurate studies verifying these assumptions have been made. 3. The relationship between nutrition, nutritional status, lactose tolerance and adverse events. Is nutrition a prognostic factor in the outcome of colorectal cancer and does the tolerance of chemo- and radiotherapy correlate with nutritional factors? 4. Lactobacillus GG:s preventive and curative effect on gastrointestinal side-effects, especially the reduction of diarrhoea incidence that is apparent in 33-42% of patients. 5. Effect of hydrolyzed guar gum fiber on gastrointestinal side-effects. Benefiber is an essential ingredient of the nutritional support given during periods of gastrointestinal side-effects. Does the fiber reduce and alleviate diarrhoea? 6. The possible synergetic effect of guar gum fiber and lactobacillus GG will also be assessed. 7. Effects of prophylactic additional nutritional support on nutritional status and adverse events. Supplemental oral nutrition with fiber is given prophylactically during 8 days per month in order to maintain a resonable oral intake when side-effects affect eating. Can nutritional disadvantegous changes of chemo- and radiotherapy be prevented? 8. Changes in gastrointestinal bacterial flora during treatment and symptoms. General chan	—

Measure

Time frame

1. Differences in toxicity profile, adverse events and quality of life in bolus and infusional treatment regimens. The aim is to develop a new adjuvant treatment standard that enables cytostatics in home care, and to prevent and treat side-effects efficiently. The intention is to interfere with patients' everyday life as little as possible during the 6 months of adjuvant treatment. 2. Cost-benefit differences in bolus and infusional treatment. In preliminary calculations the continuous infusion at home should be 30% cheaper than bolus treatment in the clinics. Though continuous infusion has been considered expensive, no accurate studies verifying these assumptions have been made. 3. The relationship between nutrition, nutritional status, lactose tolerance and adverse events. Is nutrition a prognostic factor in the outcome of colorectal cancer and does the tolerance of chemo- and radiotherapy correlate with nutritional factors? 4. Lactobacillus GG:s preventive and curative effect on gastrointestinal side-effects, especially the reduction of diarrhoea incidence that is apparent in 33-42% of patients. 5. Effect of hydrolyzed guar gum fiber on gastrointestinal side-effects. Benefiber is an essential ingredient of the nutritional support given during periods of gastrointestinal side-effects. Does the fiber reduce and alleviate diarrhoea? 6. The possible synergetic effect of guar gum fiber and lactobacillus GG will also be assessed. 7. Effects of prophylactic additional nutritional support on nutritional status and adverse events. Supplemental oral nutrition with fiber is given prophylactically during 8 days per month in order to maintain a resonable oral intake when side-effects affect eating. Can nutritional disadvantegous changes of chemo- and radiotherapy be prevented? 8. Changes in gastrointestinal bacterial flora during treatment and symptoms. General chan

—

Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

Finland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 10, 2026