Last reviewed · How we verify
NCT00647530: FOxTROT
Fluorouracil and Oxaliplatin With or Without Panitumumab In Treating Patients With High-Risk Colon Cancer That Can Be Removed by Surgery
Phase 2, PHASE3 trial testing panitumumab in Colorectal Cancer in 1,053 participants. Status unknown.
23 December 2016
Quick facts
| Lead sponsor | University of Birmingham |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1,053 |
| Start date | 15 May 2008 |
| Primary completion | 23 December 2016 |
| Estimated completion | 31 December 2019 |
| Sites | 10 locations across United Kingdom |
Drugs / interventions tested
- panitumumab
- capecitabine (capecitabine) — full drug profile →
- fluorouracil — full drug profile →
- oxaliplatin (Oxaliplatin) — full drug profile →
Conditions studied
- Colorectal Cancer — all drugs for Colorectal Cancer →
Sponsor
University of Birmingham
Who can join
18 and older, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
RATIONALE: Drugs used in chemotherapy, such as fluorouracil and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether chemotherapy is more effective with or without panitumumab in treating patients with colon cancer. PURPOSE: This randomized phase III trial assessing whether preoperative chemotherapy and/or an anti-EGFR monoclonal antibody improve outcome in high risk operable colon cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Preoperative Chemotherapy for Operable Colon Cancer: Mature Results of an International Randomized Controlled Trial.
Morton D, Seymour M, Magill L, Handley K, et al · · 2023 · cited 285× · PMID 36657089 · DOI 10.1200/jco.22.00046 -
Dynamic and adaptive cancer stem cell population admixture in colorectal neoplasia.
Vasquez EG, Nasreddin N, Valbuena GN, Mulholland EJ, et al · · 2022 · cited 96× · PMID 35931031 · DOI 10.1016/j.stem.2022.07.008 -
Early stage colon cancer: Current treatment standards, evolving paradigms, and future directions.
Chakrabarti S, Peterson CY, Sriram D, Mahipal A. · · 2020 · cited 89× · PMID 32879661 · DOI 10.4251/wjgo.v12.i8.808 -
Neoadjuvant Chemotherapy without Radiation in Colorectal Cancer.
Bhudia J, Glynne-Jones R, Smith T, Hall M. · · 2020 · cited 9× · PMID 32968364 · DOI 10.1055/s-0040-1713746 -
Immunotherapy for Early Stage Colorectal Cancer: A Glance into the Future.
Cohen R, Shi Q, André T. · · 2020 · cited 9× · PMID 32708216 · DOI 10.3390/cancers12071990 -
Risk of Bowel Obstruction in Patients Undergoing Neoadjuvant Chemotherapy for High-risk Colon Cancer: A Nested Case-control-matched Analysis of an International, Multicenter, Randomized Controlled Trial (FOxTROT).
FOxTROT Collaborating Group. · · 2024 · cited 7× · PMID 37947140 · DOI 10.1097/sla.0000000000006145 -
Evaluating the oncological safety of neoadjuvant chemotherapy in locally advanced colon carcinoma: a systematic review and meta-analysis of randomised clinical trials and propensity-matched studies.
Davey MG, Amir AH, Ryan OK, Donnelly M, et al · · 2023 · cited 7× · PMID 37432559 · DOI 10.1007/s00384-023-04482-x -
A panel of DNA methylation markers for the classification of consensus molecular subtypes 2 and 3 in patients with colorectal cancer.
van den Berg I, Smid M, Coebergh van den Braak RRJ, van de Wiel MA, et al · · 2021 · cited 6× · PMID 34510716 · DOI 10.1002/1878-0261.13098
Verify or expand the search:
- PubMed search for NCT00647530
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of panitumumab
Trials testing the same drug.
- NCT07094204 — A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors · Phase 1 · recruiting
- NCT06714357 — ValproIc Acid to Potentiate Anti-EGFR Treatment Efficacy and Prevent/Revert Resistance in Colorectal Cancer · Phase 2 · recruiting
- NCT01814501 — Panitumumab and Chemotherapy in Patients With Advanced Colorectal Cancer After Prior Therapy With Bevacizumab · Phase 2 · completed
- NCT01312857 — Study of Hepatic Arterial Infusion With Intravenous Irinotecan, 5FU and Leucovorin With or Without Panitumumab, in Patie · Phase 2 · completed
- NCT00820248 — Radiation + Cisplatin or Panitumumab in Locally Advanced Stage III or Stage IV Head and Neck Cancer · Phase 3 · completed
Other recruiting trials for Colorectal Cancer
Currently open trials in the same condition.
- NCT07152821 — Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcino · Phase 3 · recruiting
- NCT07353645 — KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer · Phase 1, PHASE2 · recruiting
- NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications · Phase 1, PHASE2 · recruiting
- NCT07523919 — Functional and Respiratory Determinants of Long-Term Colorectal Cancer Outcomes · recruiting
- NCT07529301 — Functional and Respiratory Predictors of Early Postoperative Outcomes · recruiting
Other University of Birmingham trials
Trials by the same sponsor.
- NCT07160686 — Apixaban to Prevent Venous Thromboembolism in Ambulatory Lung Cancer Patients Undergoing Systemic Anticancer Treatment · Phase 3 · not yet recruiting
- NCT07446166 — TETANUS Antibody Detection in Saliva Study · NA · not yet recruiting
- NCT07294794 — Personalised Pharmacometabolomic-guided Strategy Trial to Optimise Treatment for Hypertension · NA · not yet recruiting
- NCT07246356 — Feasibility and Efficacy of GTEP for Birth Trauma · NA · recruiting
- NCT06932653 — Reducing Deaths After Surgery in Low- and Middle-income Countries: A Pilot Cluster Randomised Trial · NA · not yet recruiting
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 NCT00647530 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- 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 Birmingham
- Last refreshed: 17 May 2019
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/NCT00647530.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing