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NCT00647530: FOxTROT

Fluorouracil and Oxaliplatin With or Without Panitumumab In Treating Patients With High-Risk Colon Cancer That Can Be Removed by Surgery

Status unknown Phase 2, PHASE3 Last updated 17 May 2019
What this trial tests

Phase 2, PHASE3 trial testing panitumumab in Colorectal Cancer in 1,053 participants. Status unknown.

Timeline
15 May 2008
Primary endpoint
23 December 2016
31 December 2019

Quick facts

Lead sponsorUniversity of Birmingham
PhasePhase 2, PHASE3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment1,053
Start date15 May 2008
Primary completion23 December 2016
Estimated completion31 December 2019
Sites10 locations across United Kingdom

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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:

Other trials of panitumumab

Trials testing the same drug.

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Other University of Birmingham trials

Trials by the same sponsor.

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Data sources for this page

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.

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