Clinical trial · Interventional
Trial Comparing Two Strategies of Chemotherapy for Metastatic Colorectal Cancer
Randomized Trial of Treatment Strategy for Chemotherapy in Colorectal Cancer, FFCD 2000-05
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The standard treatment of metastatic colorectal cancer is based on systemic chemotherapy. Several effective drugs are currently available and can be administered either sequentially or in combination. Most patients receive 2 or 3 lines of chemotherapy. The aim of this randomized trial is to evaluate the potential benefit of a bitherapy with 5-fluorouracil (5-FU) and oxaliplatin as first line chemotherapy compared with a sequential chemotherapy with 5-FU alone as first line chemotherapy followed by the combination of 5-FU with oxaliplatin in case of progressive disease, in terms of progression-free survival and overall survival in patients with advanced colorectal cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Metastasis | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil | Drug | Fluorouracil | ALIAS |
| irinotecan | Drug | Irinotecan | ALIAS |
| leucovorin | Drug | Leucovorin | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression-free survival after two lines of chemotherapy, defined as the time duration from randomization until progression after two lines of chemotherapy or death whatever the cause in the absence of progression or last-follow-up
Secondary outcomes (7)
- measure
- Overall survival
- measure
- Secondary surgery
- measure
- Response rate
- measure
- Progression-free survival after the first and the third line of chemotherapy
- measure
- Safety
- measure
- Quality of life
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed metastatic colorectal adenocarcinoma * Unresectable metastasis * Bidimensionally measurable disease (World Health Organization \[WHO\] criteria) * WHO performance status of 2 or less * Adequate hematologic functions (neutrophil count, at least 1500 per cubic millimeter; and platelet count, at least 100,000 per cubic millimetre) * Adequate renal function (serum creatinine, less than 125 micromol per liter) * Adequate liver function (bilirubin, not more than 5 times the upper limit of normal) * No previous chemotherapy other than previous adjuvant chemotherapy or concomitant chemoradiotherapy with 5-fluorouracil and leucovorin for the treatment of the primary tumor completed at least 6 months before inclusion * Signed written inform consent * Quality of life questionnaire (QLQ C-30) filled out Exclusion Criteria: * Pregnant or breast - feeding women * Impossibility of regular follow-up for psychological, social or geographical reason * Severe cardiac, respiratory, renal or hepatic failure * Active coronary heart disease * Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study * Central nervous system metastases * Past history of second malignancies * Another investigational drug * Chronic inflammatory bowel disease * Previous chemotherapy with irinotecan or oxaliplatin based regimens
References
Publications (2)
- DERIVEDPenichoux J, Michiels S, Bouche O, Etienne PL, Texereau P, Auby D, Rougier P, Ducreux M, Pignon JP; FFCD 2000-05 trial investigators. Taking into account successive treatment lines in the analysis of a colorectal cancer randomised trial. Eur J Cancer. 2013 May;49(8):1882-8. doi: 10.1016/j.ejca.2013.02.006. Epub 2013 Mar 13. PMID 23490654
- DERIVEDDucreux M, Malka D, Mendiboure J, Etienne PL, Texereau P, Auby D, Rougier P, Gasmi M, Castaing M, Abbas M, Michel P, Gargot D, Azzedine A, Lombard-Bohas C, Geoffroy P, Denis B, Pignon JP, Bedenne L, Bouche O; Federation Francophone de Cancerologie Digestive (FFCD) 2000-05 Collaborative Group. Sequential versus combination chemotherapy for the treatment of advanced colorectal cancer (FFCD 2000-05): an open-label, randomised, phase 3 trial. Lancet Oncol. 2011 Oct;12(11):1032-44. doi: 10.1016/S1470-2045(11)70199-1. Epub 2011 Sep 6. PMID 21903473