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NCT00262808 · ClinicalTrials.gov registry record · Phase 2
GM-CSF and Combination Chemotherapy in Treating Patients Who Are Undergoing Surgery for Stage II or Stage III Colon Cancer
A Phase 2 study, sponsored by University of Rochester.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT00262808 is a Phase 2 study that has completed, run by University of Rochester. The registered enrollment target is 50 participants.
The verdict
NCT00262808, a Phase 2 study, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
RATIONALE: Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy or kill tumor cells. Drugs used in chemotherapy, such as fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy after surgery may kill any remaining tumor cells. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. PURPOSE: This phase II trial is studying how well GM-CSF and combination chemotherapy work in treating patients who are undergoing surgery for stage II or stage III colon cancer.
Interventions
- DRUG oxaliplatin
- DRUG fluorouracil
- DRUG leucovorin calcium
- PROCEDURE adjuvant therapy
- BIOLOGICAL sargramostim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2004-03 |
| Est. Completion | 2006-09 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00262808
The ClinicalTrials.gov registry entry for NCT00262808 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Rochester, which has 636 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which oxaliplatin is the first listed.
NCT00262808 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00262808 about?
NCT00262808 is a clinical study titled "GM-CSF and Combination Chemotherapy in Treating Patients Who Are Undergoing Surgery for Stage II or Stage III Colon Cancer". RATIONALE: Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy or kill tumor cells. Drugs used in chemotherapy, such as fluorouracil, leucovorin, and ...
What is the current status of trial NCT00262808?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2004-03. Estimated completion is 2006-09.
What interventions are being tested in trial NCT00262808?
The interventions under investigation include: oxaliplatin (DRUG), fluorouracil (DRUG), leucovorin calcium (DRUG), adjuvant therapy (PROCEDURE), sargramostim (BIOLOGICAL).
Who is sponsoring clinical trial NCT00262808?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
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