Colorectal CancerPhase 2/3FOxTROTNCT00647530
Fluorouracil and Oxaliplatin With or Without Panitumumab In Treating Patients With High-Risk Colon Cancer That Can Be Removed by Surgery
A Phase 2/3 study testing panitumumab, capecitabine and fluorouracil in people with Colorectal Cancer, run by University of Birmingham at 10 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- panitumumab, capecitabine and fluorouracil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,053 participants
- Where
- 10 sitesUnited Kingdom
- Study dates
- 15 May 2008to 31 Dec 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven adenocarcinoma of the colon or high grade dysplasia on histology plus unequivocal radiological evidence of invasive cancer.
- A candidate for adjuvant oxaliplatin/ fluoropyrimidine chemotherapy based on:
- Either radiological high risk (rT4 or rT3 tumour with extramural extension ≥ 5mm)
- Or radiological intermediate risk (rT3 tumour with <5mm extramural extension) and younger age/good general health
- Patients presenting with acute colonic obstruction may enter the trial only after obstruction is relieved by a successful defunctioning stoma, and when recovered to a fitness level consistent with the other eligibility criteria
- Adequate full blood count: WBC >3.0 x109/l; Plts >100 x109/l. Anaemia (Hb < 10.0 g/dl) is not an exclusion, but should be corrected by transfusion prior to surgery and chemotherapy. If Hb remains low despite transfusions, surgery and chemotherapy can be given at the decision of the surgical and oncology teams.
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- Adequate renal biochemistry: GFR >50 ml/min calculated by the Wright or Cockroft formula or EDTA clearance >70 ml/min
- Adequate hepatobiliary function: bilirubin < 25 μmol/l (Patients with Gilbert's syndrome who have raised bilirubin but otherwise normal liver function tests are eligible for the study.)
- Aged 18 or over
- WHO performance status of 0, 1 or 2
- If female and of childbearing potential, must:
- Have a negative pregnancy test ≤72hours prior to initiating study treatment
- Agree to avoid pregnancy during and for 6 months after study treatment
- If male with a partner of childbearing potential, must:
- Agree to use adequate, medically approved, contraceptive precautions during and for 90 days after the last dose of study treatment
- Patient able and willing to provide written informed consent for the study
Who cannot join
- Any patient for whom radiotherapy is advised by the MDT
- Strong evidence of distant metastases or peritoneal nodules (M1)
- Peritonitis (secondary to perforated tumour)
- Colonic obstruction that has not been defunctioned
- Serious medical comorbidity, eg uncontrolled inflammatory bowel disease, uncontrolled angina or recent (<6 months) MI
- Another serious medical condition judged to compromise ability to tolerate neoadjuvant therapy and/or surgery
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- Any other malignant disease within the preceding 5 years with the exception of non-melanomatous skin cancer, carcinoma in situ and early stage disease with a recurrence risk <5%
- ADDITIONAL EXCLUSION CRITERIA FOR PANITUMUMAB RANDOMISATION
- RAS-mutant or unknown RAS status tumours
- Allocated post-operative chemotherapy
- History of interstitial pneumonitis or pulmonary fibrosis
- History of severe or life-threatening hypersensitivity reactions
- Serum magnesium levels within the normal range at trial entry (which can include intravenous correction)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United Kingdom10 sites
Birmingham Clinical Trials Unit
Birmingham, England, B15 2RR
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, B15 2TH
Queen Elizabeth Hospital
Gateshead, England, NE9 6SX
Huddersfield Royal Infirmary
Huddersfield, West Yorks, England, HD3 3EA
Royal Lancaster Infirmary
Lancaster, England, LA1 4RP
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Clatterbridge Centre for Oncology
Metropolitan Borough of Wirral, England, CH63 4JY
Derriford Hospital
Plymouth, England, PL6 8DH
Southport and Formby District General Hospital
Southport, England, PR8 6PN
Sandwell General Hospital
West Bromwich, England, B71 4HJ
About this study
Official title: FOxTROT - Fluoropyrimidine, Oxaliplatin and Targeted Receptor Pre-Operative Therapy: a Controlled Trial in High-Risk Operable Colon Cancer
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.
Read the detailed description
FOxTROT is a multi-centre randomised controlled trial (RCT) with the following objectives:
Primary objectives:
- To determine if neoadjuvant chemotherapy with or without panitumumab followed by deferred surgery and completion of chemotherapy postoperatively can reduce the 2-year recurrence as compared to surgery and postoperative chemotherapy with or without panitumumab.
- To determine if, in patients with RAS-wt tumours, adding panitumumab to neoadjuvant therapy increases anti-tumour activity as measured by tumour shrinkage.
Secondary
- To assess the accuracy of pre-treatment CT scan staging.
- To assess the tolerability of the neoadjuvant therapies.
- To assess the nature and frequency of surgical complications.
- To measure the impact of the treatments on quality of life and on resource usage.
- To assess whether adding panitumumab to neoadjuvant CT reduces 2-year recurrence
- To assess the prognostic and predictive value of tumour biomarkers
- To assess the influence of resectional quality on outcome
OUTLINE: This is a multicenter study. Patients are stratified according to age (< 50 year vs 50-59 years vs 60-69 years vs ≥ 70 years), radiological T-stage (T3 vs T4), radiological nodal status (Nx vs N0 vs N1 vs N2), site of primary tumor, proposed chemotherapy (OxMdG vs OxCap), and defunctioning colostomy (yes vs no). Planned chemo duration 12 or 24 weeks.
Patients receive 1 of the 2 following treatment regimens:
- OxMdG: Patients receive oxaliplatin IV and folinic acid IV over 2 hours followed by fluorouracil IV continuously over 46 hours on day 1 for 1 course.
- OxCap: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-15 for 1 course.
Patients are randomized to 1 of 2 treatment arms.
- Neoadjuvant therapy:
- Arm I: Patients receive 1 of the following chemotherapy regimens:
- OxMdG: Patients receive oxaliplatin IV over 2 hours and fluorouracil IV continuously over 46 hours on day 1. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
- OxCap: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-15. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive the following regimen:
- OxMdG + panitumumab: Patients receive panitumumab IV over 60 minutes on day 1 followed by oxaliplatin IV over 2 hours and fluorouracil IV continuously over 46 hours on day 1. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Approximately 52 days after beginning chemotherapy, patients in both arms proceed to surgery.
- Surgery: Patients in both arms undergo surgical resection of the primary tumour.
- Adjuvant therapy: Beginning 4-8 weeks after completion of surgery, patients receive adjuvant treatment on the same arm for which they received neoadjuvant therapy.
- Patients receive either nine 2-week courses of OxMdG therapy or six 3-week courses of OxCap therapy.
Tumour tissue is collected during surgery and blood samples are collected periodically for biomarker studies. Samples are analyzed for the detection of KRAS and NRAS mutations; the detection of EGFR expression and/or functional genetic polymorphisms of the EGFR gene via PCR; the detection of copy number EGFR gene amplification via fluorescence in situ hybridization (FISH); the detection of EGFR activation via immunohistochemistry (IHC); the detection of EGFR by downstream parameters via western blotting and/or gene expression microarray techniques; for proteomics; and for epigenetics.
Patients complete quality of life questionnaires prior to surgery, before first course of postoperative chemotherapy, and at 1 year following randomization.
After completion of study treatment, patients are followed every 6 months for 3 years and then annually thereafter.
- Conditions
- Colorectal Cancer
- Being tested
- panitumumab, capecitabine, fluorouracil, oxaliplatin
- Keywords
- adenocarcinoma of the colon, stage I colon cancer, stage II colon cancer, stage III colon cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
panitumumabBiological
capecitabineDrug
fluorouracilDrug
oxaliplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Pre&Post Op Chemo | Experimental | 12 weeks of OxFP neuoadjuvantly followed by surgery and 18 weeks of OxFP Receives: Drug: capecitabine; Drug: fluorouracil; Drug: oxaliplatin |
| Pre&Post Op Chemo with P-mab | Experimental | 12 weeks of OxFP and panitumumab neuoadjuvantly followed by surgery and 18 weeks of OxFP alone. Receives: Biological: panitumumab; Drug: fluorouracil; Drug: oxaliplatin |
| Post Op Chemo | Active comparator | surgery followed by 24 weeks of OxFP. Receives: Drug: capecitabine; Drug: fluorouracil; Drug: oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from recurrence or persistent disease (including failure of macroscopic disease clearance at primary surgery) within the first two years following randomization
Measured: 2 year post randomization
Pathological down-staging as measured by depth of extramural spread among patients allocated to preoperative chemotherapy with or without panitumumab
Measured: Time of surgery
Secondary outcomes (11)
Death from colon cancer
Measured: 2 years
Overall survival
Measured: 2 years
Freedom from recurrence or persistent disease at 2 years (panitumumab comparison)
Measured: 2 years
Pathological assessment of downstaging (involvement of lymph nodes, serosa, and resection margin) and quality of resection specimen
Measured: at surgery
Quality of resection specimen and distance to high-tie
Measured: post surgery
Radiological assessment of response to neoadjuvant treatment
Measured: prior to surgery
Quality of life by EORTC QLQ C-30 and EuroQol EQ-5D
Measured: before surgery, before 1st post-op chemo, 1 year post randomization
Lenght of hospital stay
Measured: post surgery
Surgical morbidity/mortality
Measured: 30 days post surgery
Chemotherapy toxicity
Measured: during chemotherapy administration
Adverse events
Measured: throughout the trial, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2008 (estimated)
- Study start15 May 2008
- Primary completion23 Dec 2016
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pre- plus Post-operative chemotherapy (+/- Panitumumab) vs standard post-operative chemotherapy.
- Masking
- None (open label)
- Enrolment
- 1,053 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dion Morton, MD, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00647530
- Sponsor's protocol ID
- BCTU-FOXTROT-001
- Other IDs
- CDR0000590089, ISCRTN 87163246, EUDRACT 2007-001987-55, EU-20830, MREC-07/S0703/57, UKCRN 3771
- Acronym
- FOxTROT
- Status last verified
- May 2019
- First submitted
- 28 Mar 2008
- Last updated
- 17 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
FOxTROT Collaborating Group. 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). Ann Surg. 2024 Aug 1;280(2):283-293. doi: 10.1097/SLA.0000000000006145. Epub 2023 Nov 10.
PubMed 37947140Morton D, Seymour M, Magill L, Handley K, Glasbey J, Glimelius B, Palmer A, Seligmann J, Laurberg S, Murakami K, West N, Quirke P, Gray R; FOxTROT Collaborative Group. Preoperative Chemotherapy for Operable Colon Cancer: Mature Results of an International Randomized Controlled Trial. J Clin Oncol. 2023 Mar 10;41(8):1541-1552. doi: 10.1200/JCO.22.00046. Epub 2023 Jan 19.
PubMed 36657089van den Berg I, Smid M, Coebergh van den Braak RRJ, van de Wiel MA, van Deurzen CHM, de Weerd V, Martens JWM, IJzermans JNM, Wilting SM. A panel of DNA methylation markers for the classification of consensus molecular subtypes 2 and 3 in patients with colorectal cancer. Mol Oncol. 2021 Dec;15(12):3348-3362. doi: 10.1002/1878-0261.13098. Epub 2021 Sep 30.
PubMed 34510716
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FOxTROT - Fluoropyrimidine, Oxaliplatin and Targeted Receptor Pre-Operative Therapy: a Controlled Trial in High-Risk Operable Colon Cancer
- ClinicalTrials.gov ID
- NCT00647530
- Acronym / sponsor ID
- FOxTROT / BCTU-FOXTROT-001
- Conditions
- Colorectal Cancer
- Keywords
- adenocarcinoma of the colon, stage I colon cancer, stage II colon cancer, stage III colon cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,053 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- 15 May 2008 (actual)
- Primary completion
- 23 Dec 2016 (actual)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 31 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
FOxTROT is a multi-centre randomised controlled trial (RCT) with the following objectives:
Primary objectives:
- To determine if neoadjuvant chemotherapy with or without panitumumab followed by deferred surgery and completion of chemotherapy postoperatively can reduce the 2-year recurrence as compared to surgery and postoperative chemotherapy with or without panitumumab.
- To determine if, in patients with RAS-wt tumours, adding panitumumab to neoadjuvant therapy increases anti-tumour activity as measured by tumour shrinkage.
Secondary
- To assess the accuracy of pre-treatment CT scan staging.
- To assess the tolerability of the neoadjuvant therapies.
- To assess the nature and frequency of surgical complications.
- To measure the impact of the treatments on quality of life and on resource usage.
- To assess whether adding panitumumab to neoadjuvant CT reduces 2-year recurrence
- To assess the prognostic and predictive value of tumour biomarkers
- To assess the influence of resectional quality on outcome
OUTLINE: This is a multicenter study. Patients are stratified according to age (< 50 year vs 50-59 years vs 60-69 years vs ≥ 70 years), radiological T-stage (T3 vs T4), radiological nodal status (Nx vs N0 vs N1 vs N2), site of primary tumor, proposed chemotherapy (OxMdG vs OxCap), and defunctioning colostomy (yes vs no). Planned chemo duration 12 or 24 weeks.
Patients receive 1 of the 2 following treatment regimens:
- OxMdG: Patients receive oxaliplatin IV and folinic acid IV over 2 hours followed by fluorouracil IV continuously over 46 hours on day 1 for 1 course.
- OxCap: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-15 for 1 course.
Patients are randomized to 1 of 2 treatment arms.
- Neoadjuvant therapy:
- Arm I: Patients receive 1 of the following chemotherapy regimens:
- OxMdG: Patients receive oxaliplatin IV over 2 hours and fluorouracil IV continuously over 46 hours on day 1. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
- OxCap: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-15. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive the following regimen:
- OxMdG + panitumumab: Patients receive panitumumab IV over 60 minutes on day 1 followed by oxaliplatin IV over 2 hours and fluorouracil IV continuously over 46 hours on day 1. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Approximately 52 days after beginning chemotherapy, patients in both arms proceed to surgery.
- Surgery: Patients in both arms undergo surgical resection of the primary tumour.
- Adjuvant therapy: Beginning 4-8 weeks after completion of surgery, patients receive adjuvant treatment on the same arm for which they received neoadjuvant therapy.
- Patients receive either nine 2-week courses of OxMdG therapy or six 3-week courses of OxCap therapy.
Tumour tissue is collected during surgery and blood samples are collected periodically for biomarker studies. Samples are analyzed for the detection of KRAS and NRAS mutations; the detection of EGFR expression and/or functional genetic polymorphisms of the EGFR gene via PCR; the detection of copy number EGFR gene amplification via fluorescence in situ hybridization (FISH); the detection of EGFR activation via immunohistochemistry (IHC); the detection of EGFR by downstream parameters via western blotting and/or gene expression microarray techniques; for proteomics; and for epigenetics.
Patients complete quality of life questionnaires prior to surgery, before first course of postoperative chemotherapy, and at 1 year following randomization.
After completion of study treatment, patients are followed every 6 months for 3 years and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Pre- plus Post-operative chemotherapy (+/- Panitumumab) vs standard post-operative chemotherapy.
| Arm | Type | Receives |
|---|---|---|
| Pre&Post Op Chemo | Experimental | Drug: capecitabine, Drug: fluorouracil, Drug: oxaliplatin12 weeks of OxFP neuoadjuvantly followed by surgery and 18 weeks of OxFP |
| Pre&Post Op Chemo with P-mab | Experimental | Biological: panitumumab, Drug: fluorouracil, Drug: oxaliplatin12 weeks of OxFP and panitumumab neuoadjuvantly followed by surgery and 18 weeks of OxFP alone. |
| Post Op Chemo | Active comparator | Drug: capecitabine, Drug: fluorouracil, Drug: oxaliplatinsurgery followed by 24 weeks of OxFP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically proven adenocarcinoma of the colon or high grade dysplasia on histology plus unequivocal radiological evidence of invasive cancer.
- A candidate for adjuvant oxaliplatin/ fluoropyrimidine chemotherapy based on:
- Patients presenting with acute colonic obstruction may enter the trial only after obstruction is relieved by a successful defunctioning stoma, and when recovered to a fitness level consistent with the other eligibility criteria
- Adequate full blood count: WBC >3.0 x109/l; Plts >100 x109/l. Anaemia (Hb < 10.0 g/dl) is not an exclusion, but should be corrected by transfusion prior to surgery and chemotherapy. If Hb remains low despite transfusions, surgery and chemotherapy can be given at the decision of the surgical and oncology teams.
- Adequate renal biochemistry: GFR >50 ml/min calculated by the Wright or Cockroft formula or EDTA clearance >70 ml/min
Key exclusion criteria (13 listed)
- Any patient for whom radiotherapy is advised by the MDT
- Strong evidence of distant metastases or peritoneal nodules (M1)
- Peritonitis (secondary to perforated tumour)
- Colonic obstruction that has not been defunctioned
- Serious medical comorbidity, eg uncontrolled inflammatory bowel disease, uncontrolled angina or recent (<6 months) MI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| panitumumab | Biological | Pre&Post Op Chemo with P-mab |
| capecitabine | Drug | Post Op Chemo, Pre&Post Op Chemo |
| fluorouracil | Drug | Post Op Chemo, Pre&Post Op Chemo, Pre&Post Op Chemo with P-mab |
| oxaliplatin | Drug | Post Op Chemo, Pre&Post Op Chemo, Pre&Post Op Chemo with P-mab |
Primary outcome
Freedom from recurrence or persistent disease (including failure of macroscopic disease clearance at primary surgery) within the first two years following randomization
Time frame: 2 year post randomization
Pathological down-staging as measured by depth of extramural spread among patients allocated to preoperative chemotherapy with or without panitumumab
Time frame: Time of surgery
11 secondary outcomes
Death from colon cancer
Time frame: 2 years
Overall survival
Time frame: 2 years
Freedom from recurrence or persistent disease at 2 years (panitumumab comparison)
Time frame: 2 years
Pathological assessment of downstaging (involvement of lymph nodes, serosa, and resection margin) and quality of resection specimen
Time frame: at surgery
Quality of resection specimen and distance to high-tie
Time frame: post surgery
Radiological assessment of response to neoadjuvant treatment
Time frame: prior to surgery
Quality of life by EORTC QLQ C-30 and EuroQol EQ-5D
Time frame: before surgery, before 1st post-op chemo, 1 year post randomization
Lenght of hospital stay
Time frame: post surgery
Surgical morbidity/mortality
Time frame: 30 days post surgery
Chemotherapy toxicity
Time frame: during chemotherapy administration
Adverse events
Time frame: throughout the trial, up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
- Derived from this study: PubMed 37947140FOxTROT Collaborating Group. 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). Ann Surg. 2024 Aug 1;280(2):283-293. doi: 10.1097/SLA.0000000000006145. Epub 2023 Nov 10.
- Derived from this study: PubMed 36657089Morton D, Seymour M, Magill L, Handley K, Glasbey J, Glimelius B, Palmer A, Seligmann J, Laurberg S, Murakami K, West N, Quirke P, Gray R; FOxTROT Collaborative Group. Preoperative Chemotherapy for Operable Colon Cancer: Mature Results of an International Randomized Controlled Trial. J Clin Oncol. 2023 Mar 10;41(8):1541-1552. doi: 10.1200/JCO.22.00046. Epub 2023 Jan 19.
- Derived from this study: PubMed 34510716van den Berg I, Smid M, Coebergh van den Braak RRJ, van de Wiel MA, van Deurzen CHM, de Weerd V, Martens JWM, IJzermans JNM, Wilting SM. A panel of DNA methylation markers for the classification of consensus molecular subtypes 2 and 3 in patients with colorectal cancer. Mol Oncol. 2021 Dec;15(12):3348-3362. doi: 10.1002/1878-0261.13098. Epub 2021 Sep 30.
- Feasibility of preoperative chemotherapy for locally advanced, operable colon cancer: the pilot phase of a randomised controlled trial. Lancet Oncol. 2012 Nov;13(11):1152-60. doi: 10.1016/S1470-2045(12)70348-0. Epub 2012 Sep 25.Link provided by the sponsor.
- FOxTROT websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dion Morton, MD principal investigator
University of Birmingham
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing panitumumab, capecitabine and fluorouracil in people with Colorectal Cancer, run by University of Birmingham at 10 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from recurrence or persistent disease (including failure of macroscopic disease clearance at primary surgery) within the first two years following randomization (time frame: 2 year post randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00647530, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2019.