Condition category
Cancer
Date applied
28/11/2006
Date assigned
30/03/2007
Last edited
19/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Dr Laura Magill

ORCID ID

Contact details

Birmingham Clinical Trials Unit
School of Health and Population Sciences
Public Health Building
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Additional identifiers

EudraCT number

2007-001987-55

ClinicalTrials.gov number

NCT00647530

Protocol/serial number

N/A

Study information

Scientific title

Fluoropyrimidine, Oxaliplatin and Targeted Receptor pre-Operative Therapy: a controlled trial in high-risk operable colon cancer

Acronym

FOxTROT

Study hypothesis

For patients with high risk, operable colon cancer:
1. Does giving potent Oxaliplatin/FluoroPyrimidine (OxFP) chemotherapy preoperatively facilitate surgical clearance and eradicate micrometastases more effectively than delayed post-operative chemotherapy?
2. Does the addition of the Epidermal Growth Factor Receptor (EGFR)-targeted therapy, panitumumab, enhance the efficacy of OxFP?

Ethics approval

West Glasgow Research Ethics Committee, 05/06/2007, ref: 07/S0703/57

Study design

Open multicentre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

High risk, operable colon cancer

Intervention

An open, multicentre, randomised controlled trial.
First phase: randomised phase II assessing tolerability, feasibility and radiological/pathological downstaging.
Second phase: randomised phase III trial with primary endpoint relapse-free survival.

Arm A: Six weeks of pre-operative oxaliplatin/fluoropyrimidine chemotherapy followed by surgery then 18 weeks of post-operative oxaliplatin/fluoropyrimidine chemotherapy
Arm B: The same chemotherapy with concomitant panitumumab for the first six weeks
Arm C: Surgery then twenty four weeks of post-operative oxaliplatin/fluoropyrimidine chemotherapy
Arm D: Schedule C with concomitant panitumumab for the first six weeks of post operative therapy

The two allowable oxaliplatin/fluoropyrimidine chemotherapy regimens are twelve two-week courses of Oxaliplatin and Modified deGramont (OxMdG), or eight three-week courses of Oxaliplatin and Capecitabine (OxCap). Patients randomised to receive panitumumab receive this by intravenous (IV) infusion over 60 minutes at 6 mg/kg on day one of each of the first three two-week OxMdG cycles; or at 9 mg/kg on day one of each of the first two three-week OxCap cycles, immediately prior to the start of the chemotherapy regimen.

Post-operative adjuvant therapy will be given, regardless of trial arm and operative histology.

Intervention type

Drug

Phase

Phase II/III

Drug names

Fluoropyrimidine, oxaliplatin, panitumumab

Primary outcome measures

1. Pre- plus post-operative versus post-operative chemotherapy: freedom from recurrence (or residual disease) at two years after randomisation (arms A and B versus C and D)
2. Panitumumab versus not: pathological down-staging (arm B versus A)

Secondary outcome measures

1. Death from colon cancer
2. Overall survival
3. Health-related quality of life
4. Pathological assessment of down-staging (involvement of lymph nodes, serosa, resection margin), and quality of resection specimen
5. Radiological assessment of response in neoadjuvant treatment arms
6. CarcinoEmbryonic Antigen (CEA) level following neo-adjuvant therapy
7. Health Service resource usage
8. Adverse events
9. Surgical morbidity/mortality

Overall trial start date

01/01/2007

Overall trial end date

01/03/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically proven colon cancer with a radiological staging of T3, NX, M0
2. Computed Tomography (CT) scan criteria of poor prognosis (T4 or T3 and more than 5 mm extramural depth and/or probable nodal involvement and/or probable vascular invasion)
3. Fit for the neoadjuvant treatments
4. Patients who have presented with acute colonic obstruction if a successful defunctioning or stent procedure has been performed
5. Patients able and willing to provide written informed consent for the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150 in the pilot phase then a further 900

Participant exclusion criteria

1. Tumour within 15 cm of the anal verge as judged by sigmoidoscopy, or below the level of the sacral promontory, as judged by sagittal CT
2. Indication for radiotherapy
3. Evidence of disseminated disease (M1)
4. Peritonitis (secondary to perforated tumour)
5. Under the age of 18 or pregnant
6. Serious medical co-morbidity

Recruitment start date

01/04/2008

Recruitment end date

31/12/2016

Locations

Countries of recruitment

Denmark, Sweden, United Kingdom

Trial participating centre

University of Birmingham
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Research & Enterprise
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 3898
res-ent@bham.ac.uk

Sponsor type

University/education

Website

http://www.bham.ac.uk/default.asp

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23017669

Publication citations

  1. Results

    Foxtrot Collaborative Group, Feasibility of preoperative chemotherapy for locally advanced, operable colon cancer: the pilot phase of a randomised controlled trial., Lancet Oncol., 2012, 13, 11, 1152-1160, doi: 10.1016/S1470-2045(12)70348-0.

Additional files

Editorial Notes

On 19/02/2016 the recruitment end date was changed from 31/12/2015 to 31/12/2016. On 10/07/2015 the overall trial end date was changed from 31/12/2015 to 01/03/2018. On 25/06/2015 Sweden and Denmark were added to the countries of recruitment.