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

Phase 3

Completed

• Conditions: Radically operated colorectal cancer Stage II-IV; Cancer; Malignant neoplasm of colon, rectum

• Registration Number: ISRCTN98405441
• Lead Sponsor: Helsinki University Central Hospital (Finland)

Brief Summary

2007 Results article in http://www.ncbi.nlm.nih.gov/pubmed/17895895 results 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/32790589/ post-hoc analysis (added 17/08/2020) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/34359796/ Lead Time and Prognostic Role of Serum CEA, CA19-9, IL-6, CRP, and YKL-40 after Adjuvant Chemotherapy in Colorectal Cancer (added 09/08/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-16
• Study Completion: 2012-12-31
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 450

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified