Drugs / Fluorouracil
Fluorouracil
DrugFluorouracil (5-FU) is a cytotoxic chemotherapy drug in the antimetabolite and pyrimidine analogue classes. It is used systemically for cancers and topically for actinic keratosis and some superficial skin cancers. The drug entered medical use in 1962.
- Trials
- 1959
- Recruiting
- 232
- Completed
- 939
- With results
- 407
Last revised
Pipeline
Phase by status
| Phase | Recruiting | Not yet | By invitation | Active | Completed | Terminated | Withdrawn | Suspended | Unknown | Approved for marketing | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Early Phase 1 | 2 | — | — | 2 | 10 | 3 | — | — | 1 | — | 18 |
| Phase 1 | 35 | 3 | — | 18 | 135 | 23 | 6 | — | 15 | — | 235 |
| Phase 1/2 | 28 | 8 | — | 6 | 65 | 23 | 18 | — | 10 | — | 158 |
| Phase 2 | 89 | 25 | 1 | 55 | 415 | 111 | 34 | 3 | 148 | — | 881 |
| Phase 2/3 | 6 | 6 | — | 5 | 22 | 6 | 5 | — | 11 | — | 61 |
| Phase 3 | 58 | 19 | — | 29 | 245 | 29 | 9 | 2 | 85 | — | 476 |
| Phase 4 | 3 | 5 | 1 | — | 15 | 2 | 2 | 1 | 12 | — | 41 |
| Not applicable | 8 | 5 | 1 | 1 | 21 | 3 | 3 | — | 18 | — | 60 |
| Unknown | 3 | 2 | 1 | 2 | 11 | 1 | — | — | 7 | 2 | 29 |
Trials started per year
Conditions studied, by phase
| Condition | Early Phase 1 | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | Phase 4 | Not applicable | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Colorectal Neoplasms | 1 | 71 | 36 | 223 | 13 | 133 | 10 | 8 | 7 | 502 |
| Rectal Neoplasms | — | 37 | 15 | 136 | 6 | 61 | 1 | 10 | 1 | 267 |
| Colonic Neoplasms | 3 | 31 | 12 | 87 | 6 | 72 | 2 | 5 | 1 | 219 |
| Pancreatic Neoplasms | 3 | 32 | 27 | 82 | 6 | 32 | 1 | 4 | 4 | 191 |
| Stomach Neoplasms | 1 | 22 | 12 | 96 | 6 | 38 | 4 | 6 | 2 | 187 |
| Esophageal Neoplasms | — | 16 | 13 | 71 | 3 | 24 | 2 | 5 | 1 | 135 |
| Breast Neoplasms | 1 | 10 | 1 | 35 | 2 | 61 | 3 | 5 | 1 | 119 |
| Neoplasm Metastasis | — | 23 | 8 | 58 | 3 | 22 | 2 | 1 | 1 | 118 |
| Squamous Cell Carcinoma of Head and Neck | 1 | 10 | 12 | 44 | 2 | 27 | — | — | 1 | 97 |
| Neoplasms | — | 30 | 6 | 37 | 3 | 11 | 2 | 2 | 2 | 93 |
Most active sponsors
| # | Sponsor | Trials | Phase 3 |
|---|---|---|---|
| 1 | National Cancer Institute (NCI) | 82 | 18 |
| 2 | Sun Yat-sen University | 58 | 32 |
| 3 | M.D. Anderson Cancer Center | 39 | 3 |
| 4 | Fudan University | 35 | 12 |
| 5 | Alliance for Clinical Trials in Oncology | 32 | 14 |
| 6 | European Organisation for Research and Treatment of Cancer - EORTC | 31 | 16 |
| 7 | Memorial Sloan Kettering Cancer Center | 31 | 0 |
| 8 | UNICANCER | 31 | 15 |
| 9 | Hoffmann-La Roche | 30 | 11 |
| 10 | Sanofi | 29 | 13 |
Most studied interventions
| # | Intervention | Trials |
|---|---|---|
| 1 | Fluorouracil | 1959 |
| 2 | Leucovorin | 1042 |
| 3 | Oxaliplatin | 877 |
| 4 | Irinotecan | 484 |
| 5 | Cisplatin | 441 |
| 6 | Bevacizumab | 302 |
| 7 | Capecitabine | 295 |
| 8 | Docetaxel | 231 |
| 9 | Radiotherapy | 223 |
| 10 | Gemcitabine | 196 |
Evidence
- Results reported
- 43.3%407 of 939 completed
- Published
- 25.1%236 of 939 completed
- Primary endpoint met
- 42.1%80 of 190 analyses
- Median months to report
- 19
Documents disclosed
Trial profile
- Median enrollment
- 78
- Median duration
- 56months
- Countries
- 85
- Study sites
- 22883
Who is enrolled
Median enrollment by phase
- Early Phase 1
- 22
- Phase 1
- 31
- Phase 1/2
- 45
- Phase 2
- 53
- Phase 2/3
- 192
- Phase 3
- 400
- Phase 4
- 60
- Not applicable
- 74
- Unknown
- 150
Where trials run
Busiest cities
| # | City | Country | Trials |
|---|---|---|---|
| 1 | New York | United States | 225 |
| 2 | Chicago | United States | 181 |
| 3 | Boston | United States | 180 |
| 4 | Houston | United States | 175 |
| 5 | Los Angeles | United States | 172 |
| 6 | Guangzhou | China | 161 |
| 7 | St Louis | United States | 161 |
| 8 | Philadelphia | United States | 153 |
| 9 | Barcelona | Spain | 144 |
| 10 | Madrid | Spain | 144 |
Terminations
- Terminated
- 201
- Withdrawn
- 77
- Suspended
- 6
- Stopped for recruitment
- 3.8%74 of 1959 trials
Stated reasons
Reasons are grouped from the sponsor's own wording with a rule-based classifier; the original text is shown below.
Recently stopped
| Trial | Status | Stated reason | Stopped |
|---|---|---|---|
| NCT04329221 Withdrawn | Withdrawn | The study was withdrawn due to lack of financial support. | 2030-01-31 |
| NCT04642287 Withdrawn | Withdrawn | The study was withdrawn due to lack of financial support. | 2030-01-31 |
| NCT05062889 Suspended | Suspended | due to earlier termination of the agreement between the Sponsor and Central Laboratory for screening test. Enrollment will reopen as soon as a new laboratory is identified. | 2029-12-31 |
| NCT05358704 Suspended | Suspended | no slots available | 2028-01-30 |
| NCT03203525 Terminated | Terminated | \<75% participation | 2026-07-22 |
| NCT02366819 Suspended | Suspended | Pending data analysis | 2026-06-08 |
| NCT00707473 Terminated | Terminated | \<75% participation | 2026-06-01 |
| NCT04488159 Withdrawn | Withdrawn | Lack of funding. | 2026-06-01 |
| NCT04949256 Terminated | Terminated | Trial was rendered as cancelled work ongoing in the book of business. | 2026-05-20 |
| NCT06704724 Terminated | Terminated | The trial was terminated for strategic business reasons; the decision was not based on any safety and/or efficacy concerns. | 2026-05-12 |
Trial records
Individual study records live on ClinicalTrials.gov. A sample of the trials counted above: