Fluorouracil for Stage IIA Colon Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Stage IIA Colon Cancer+5 MoreFluorouracil - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a combination of drugs to treat patients who have had surgery for stage II colon cancer, to see if it is more effective than a standard combination of drugs.

Eligible Conditions
  • Stage IIA Colon Cancer
  • Lynch Syndrome
  • Stage II Colon Cancer
  • Colon Signet Ring Cell Adenocarcinoma
  • Colon Mucinous Adenocarcinoma
  • Stage IIB Colon Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 10 years

Up to 10 years
Disease-free survival
Impact of tumor biologic characteristics and their relationship to overall survival
Incidence of adverse events graded by NCI CTCAE 4.0
Overall survival

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

3 Treatment Groups

Arm A (oxaliplatin, leucovorin calcium, fluorouracil)
1 of 3
Arm C (observation)
1 of 3
Arm B (combination chemotherapy, bevacizumab)
1 of 3

Active Control

Experimental Treatment

3610 Total Participants · 3 Treatment Groups

Primary Treatment: Fluorouracil · No Placebo Group · Phase 3

Arm B (combination chemotherapy, bevacizumab)Experimental Group · 5 Interventions: Bevacizumab, Fluorouracil, Laboratory Biomarker Analysis, Leucovorin Calcium, Oxaliplatin · Intervention Types: Biological, Drug, Other, Drug, Drug
Arm A (oxaliplatin, leucovorin calcium, fluorouracil)ActiveComparator Group · 4 Interventions: Fluorouracil, Laboratory Biomarker Analysis, Leucovorin Calcium, Oxaliplatin · Intervention Types: Drug, Other, Drug, Drug
Arm C (observation)NoIntervention Group · 1 Intervention: Arm C (observation) · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
FDA approved
Fluorouracil
FDA approved
Levoleucovorin
FDA approved
Oxaliplatin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 10 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,068 Previous Clinical Trials
41,125,692 Total Patients Enrolled
5 Trials studying Stage IIA Colon Cancer
2,378 Patients Enrolled for Stage IIA Colon Cancer
Al B BensonPrincipal InvestigatorECOG-ACRIN Cancer Research Group
1 Previous Clinical Trials
235 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

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Who else is applying?

What state do they live in?
North Carolina100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Duke Raleigh Hospital100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%