Panitumumab, Regorafenib, or TAS-102, in Treating Patients With Metastatic and/or Unresectable RAS Wild-Type Colorectal Cancer
Public ClinicalTrials.gov record NCT03992456. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
PULSE: A Randomized, Phase II Open Label Study of PanitUmumab RechaLlenge Versus Standard Therapy After Progression on Anti-EGFR Therapy in Patients With Metastatic and/or Unresectable RAS Wild-Type Colorectal Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase II trial studies how well retreatment with panitumumab works compared to standard of care regorafenib or trifluridine and tipiracil hydrochloride (TAS-102) in treating patients with colorectal cancer that is negative for RAS wild-type colorectal cancer has spread to other places in the body (metastatic), and/or cannot be removed by surgery (unresectable), and is negative for resistance mutations in blood. Treatment with panitumumab may interfere with the ability of tumor cells to grow and spread. Some tumors need growth factors to keep growing. Growth factor antagonists, such as regorafenib, may interfere with the growth factor and stop the tumor from growing. Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving panitumumab may work better in treating patients with colorectal cancer than with the usual treatment of regorafenib or TAS-102.
Study identification
- NCT ID
- NCT03992456
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 12 participants
Conditions and interventions
Conditions
- Metastatic Colon Adenocarcinoma
- Metastatic Colorectal Carcinoma
- Metastatic Rectal Adenocarcinoma
- Stage III Colon Cancer AJCC v8
- Stage III Colorectal Cancer AJCC v8
- Stage III Rectal Cancer AJCC v8
- Stage IIIA Colon Cancer AJCC v8
- Stage IIIA Colorectal Cancer AJCC v8
- Stage IIIA Rectal Cancer AJCC v8
- Stage IIIB Colon Cancer AJCC v8
- Stage IIIB Colorectal Cancer AJCC v8
- Stage IIIB Rectal Cancer AJCC v8
- Stage IIIC Colon Cancer AJCC v8
- Stage IIIC Colorectal Cancer AJCC v8
- Stage IIIC Rectal Cancer AJCC v8
- Stage IV Colon Cancer AJCC v8
- Stage IV Colorectal Cancer AJCC v8
- Stage IV Rectal Cancer AJCC v8
- Stage IVA Colon Cancer AJCC v8
- Stage IVA Colorectal Cancer AJCC v8
- Stage IVA Rectal Cancer AJCC v8
- Stage IVB Colon Cancer AJCC v8
- Stage IVB Colorectal Cancer AJCC v8
- Stage IVB Rectal Cancer AJCC v8
- Stage IVC Colon Cancer AJCC v8
- Stage IVC Colorectal Cancer AJCC v8
- Stage IVC Rectal Cancer AJCC v8
- Unresectable Colon Adenocarcinoma
- Unresectable Colorectal Carcinoma
- Unresectable Rectal Adenocarcinoma
Interventions
- Panitumumab Biological
- Quality-of-Life Assessment Other
- Questionnaire Administration Other
- Regorafenib Drug
- Trifluridine and Tipiracil Hydrochloride Drug
Biological · Other · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 23, 2020
- Primary completion
- Nov 30, 2023
- Completion
- Oct 6, 2024
- Last update posted
- May 20, 2024
2020 – 2024
United States locations
- U.S. sites
- 18
- U.S. states
- 13
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | — |
| UC San Diego Moores Cancer Center | La Jolla | California | 92093 | — |
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | — |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | — |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | — |
| Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | 30322 | — |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | — |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | — |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| M D Anderson Cancer Center | Houston | Texas | 77030 | — |
| Aurora Cancer Care-Milwaukee West | Wauwatosa | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03992456, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 20, 2024 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03992456 live on ClinicalTrials.gov.