Clinical trial · Observational
Genetic Trial to Study Diarrhea in Patients With Stage III Colon Cancer Who Are Receiving Chemotherapy
A Pharmacogenetic Case-Control Study of Severe Diarrhea and Life-Threatening Neutropenia in Patients Treated With Irinotecan, 5-Fluorouracil and Leucovorin
NCT00048971CI-TRIAL-00022856completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
RATIONALE: Genetic testing may help predict how patients will respond to chemotherapy drugs and may help doctors plan more effective treatment with fewer side effects. PURPOSE: Genetic study to determine how genes affect the severity of diarrhea in patients with stage III colon cancer who are receiving chemotherapy.
Conditions
Conditions (3)
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 |
| Diarrhea | — | UNRESOLVED | — |
| Neutropenia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mutation analysis | Genetic | — | UNRESOLVED |
| polymorphic microsatellite marker analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Group 1
- description
- Patients undergo collection of blood specimens for polymerase chain reaction and restriction fragment length polymorphism analysis. Genotyping assays are performed to determine UGT1A1 promoter genotyping, UGT1A1 coding polymorphisms, TS promoter polymorphisms, and MTHFR polymorphisms.
- interventionNames
- Genetic: mutation analysis
- Genetic: polymorphic microsatellite marker analysis
Primary outcomes (1)
- measure
- response
- timeFrame
- Up to 4 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed stage III adenocarcinoma of the colon
* Enrolled on CALGB-89803 and must fall into 1 of the following categories:
* Received irinotecan, fluorouracil, and leucovorin calcium and experienced at least 1 of the following:
* Grade 3-4 diarrhea
* Grade 4 neutropenia
* Grade 1 or lower diarrhea AND grade 2 or lower neutropenia
* Received fluorouracil and leucovorin calcium and experienced at least 1 of the following:
* Grade 3-4 diarrhea
* Grade 1 or lower diarrhea AND grade 2 or lower neutropenia
PATIENT CHARACTERISTICS:
Age
* 18 and overReferences
Publications (0)
Data not yet available
No reference posted for this study.