drugset / Trial / NCT00002570
Immediate Compared With Delayed Chemotherapy in Advanced Colorectal Cancer Without Signs or Symptoms of Disease
Phase 3
Completed
67 enrolled
NCIC Clinical Trials Group
North Central Cancer Treatment Group · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which treatment regimen is more effective for colorectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of immediate with delayed fluorouracil plus leucovorin in treating patients with advanced colorectal cancer without signs or symptoms of disease.
Timeline
- Start
- 1994-07-15
- Primary completion
- 2000-11
- Completion
- 2009-02-10
Publications
- Results Hummer A, Carlo W, Sullivan D, et al.: Extensive hepatic resection does not correlate with toxicity following adjuvant chemotherapy. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-526, 2002.
- Results Ackland SP, Jones M, Tu D, Simes J, Yuen J, Sargeant AM, Dhillon H, Goldberg RM, Abdi E, Shepherd L, Moore MJ. A meta-analysis of two randomised trials of early chemotherapy in asymptomatic metastatic colorectal cancer. Br J Cancer. 2005 Nov 28;93(11):1236-43. doi: 10.1038/sj.bjc.6602841.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Leucovorin | Small molecule | 20 mg/m2 | Intravenous |
| Comparator | fluorouracil | Small molecule | 425 mg/m2 | Intravenous |