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NCT03365882 · ClinicalTrials.gov registry record · Phase 2
S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic HER2/Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery
A Phase 2 study, sponsored by SWOG Cancer Research Network.
- Completed
- Registry status
- Phase 2
- Development phase
- 240
- Enrollment target
NCT03365882 is a Phase 2 study that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 240 participants.
The verdict
NCT03365882, a Phase 2 study, has completed, sponsored by SWOG Cancer Research Network.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 240 participants
- Enrollment target
Study Summary
This randomized phase II trial studies how well trastuzumab and pertuzumab work compared to cetuximab and irinotecan hydrochloride in treating patients with HER2/neu amplified colorectal cancer that has spread from where it started to other places in the body and cannot be removed by surgery. Monoclonal antibodies, such as trastuzumab and pertuzumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cetuximab and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving trastuzumab and pertuzumab may work better compared to cetuximab and irinotecan hydrochloride in treating patients with colorectal cancer.
Interventions
- BIOLOGICAL Cetuximab
- OTHER Laboratory Biomarker Analysis
- DRUG Irinotecan Hydrochloride
- BIOLOGICAL Trastuzumab
- BIOLOGICAL Pertuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2017-11-27 |
| Est. Completion | 2025-07-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03365882
The ClinicalTrials.gov registry entry for NCT03365882 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SWOG Cancer Research Network, which has 270 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cetuximab is the first listed.
NCT03365882 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03365882 about?
NCT03365882 is a clinical study titled "S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic HER2/Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery". This randomized phase II trial studies how well trastuzumab and pertuzumab work compared to cetuximab and irinotecan hydrochloride in treating patients with HER2/neu amplified colorectal cancer that has spread from where it started to other places in the body and cannot be removed by surgery. Monocl...
What is the current status of trial NCT03365882?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 240 participants. The study started on 2017-11-27. Estimated completion is 2025-07-01.
What interventions are being tested in trial NCT03365882?
The interventions under investigation include: Cetuximab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Irinotecan Hydrochloride (DRUG), Trastuzumab (BIOLOGICAL), Pertuzumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03365882?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
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