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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: Completed Phase 2 study, sponsored by SWOG Cancer Research Network.
NCT03365882 is a Phase 2 study that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 240 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To evaluate the efficacy of trastuzumab and pertuzumab (TP) in HER-2 amplified metastatic colorectal cancer (mCRC) by comparing progression-free survival (PFS) on TP compared to control arm of cetuximab and irinotecan (CETIRI). Progression-free survival is defined as the time from date of randomization to date of first documentation of progression. Using RECIST 1.1, progression is defined as a 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observe
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 |
What the finished NCT03365882 record still lists
NCT03365882 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% higher).
The record links to 0 conditions, and to 5 interventions - of which Cetuximab is the first listed.
NCT03365882 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03365882's enrollment target sits among peer trials
240 239th of 2000 higher than 1,746 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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