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NCT03300609
5-FU Based Maintenance Therapy in RAS Wild Type Metastatic Colorectal Cancer After Induction With FOLFOX Plus Panitumumab
Phase 3 trial testing Panitumumab in Colorectal Adenocarcinoma in 4 participants. Terminated before completion.
3 October 2019
Quick facts
| Lead sponsor | University of Southern California |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 4 |
| Start date | 27 February 2018 |
| Primary completion | 3 October 2019 |
| Estimated completion | 3 October 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Panitumumab
- Oxaliplatin (Oxaliplatin) — full drug profile →
- Leucovorin Calcium
- Fluorouracil — full drug profile →
- Capecitabine (capecitabine) — full drug profile →
- Quality-of-Life Assessment
- Laboratory Biomarker Analysis
Conditions studied
- Colorectal Adenocarcinoma — all drugs for Colorectal Adenocarcinoma →
- RAS Wild Type — all drugs for RAS Wild Type →
- Stage III Colorectal Cancer AJCC v7 — all drugs for Stage III Colorectal Cancer AJCC v7 →
- Stage IIIA Colorectal Cancer AJCC v7 — all drugs for Stage IIIA Colorectal Cancer AJCC v7 →
Sponsor
University of Southern California
Who can join
18 and older, any sex, with Colorectal Adenocarcinoma or RAS Wild Type. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This randomized trial studies how well panitumumab, leucovorin calcium, and fluorouracil after combination chemotherapy and panitumumab induction work in treating patients with RAS wild type colorectal cancer that has spread from where it started to nearby tissue or lymph nodes or other places in the body or cannot be removed by surgery. Monoclonal antibodies, such as panitumumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin, 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 panitumumab, leucovorin calcium, and fluorouracil after combination chemotherapy and panitumumab induction may work better in treating patients with colorectal cancer.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03300609
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of Southern California trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03300609 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Southern California
- Last refreshed: 11 June 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03300609.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing