Fluoropyrimidine, oxaliplatin and targeted receptor pre-operative therapy: ... | Not Recruiting
Fluoropyrimidine, oxaliplatin and t... | Not Recruiting
Fluoropyrimidine, oxaliplatin and targeted receptor pre-operative therapy: a controlled trial in high-risk operable colon cancer
FOxTROT

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Medical Conditions
  • High risk, operable colon cancer
Primary Contact Details
Recruitment Status
Not Recruiting
Trial source and source ID number
ISRCTN87163246
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
http://www.cancerhelp.org.uk/trials/a-trial-looking-at-chemotherapy-and-panitumumab-before-and-after-surgery-for-bowel-cancer
Research Details
  • 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?
Phase
Phase II/III
Study Design
Open multicentre randomised controlled trial
Study Type
Interventional
Intervention

Current interventions as of 05/01/2017:

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

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, immediately prior to the start of the chemotherapy regimen.

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

Previous interventions:

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
Primary Outcome Measures
    Current primary outcome measures as of 26/01/2018:
    1. Freedom from recurrent of persistent disease (including failure of macroscopic disease clearance at primary surgery) within the first two years following randomisation
    2. Pathological down-staging as measured by depth of extramural spread among patients allocated to preoperative chemotherapy with or without panitumumab

    Previous 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
    Current secondary outcome measures as of 26/01/2018:
    1. Death from colon cancer
    2. Overall survival
    3. Freedom from recurrence or persistent disease at 2 years (panitumumab comparison)
    4. Pathological assessment of downstaging (involvement of lymph nodes, serosa, and resection margin) and quality of resection specimen
    5. Quality of resection specimen and distance to high-tie
    6. Radiological assessment of response to neoadjuvant treatment
    7. Quality of life by EORTC QLQ C-30 and EuroQol EQ-5D
    8. Length of hospital stay
    9. Surgical morbidity/mortality
    10. Chemotherapy toxicity
    11. Adverse events

    Previous 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
Publication(s)
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23017669
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
150 in the pilot phase then a further 900
Participant Inclusion Criteria
    Current inclusion criteria as of 26/01/2018:
    1. Histologically proven adenocarcinoma of the colon or high grade dysplasia on histology plus unequivocal radiological evidence of invasive cancer
    2. A candidate for adjuvant oxaliplatin/ fluoropyrimidine chemotherapy based on:
    2.1. Either radiological high risk (rT4 or rT3 tumour with extramural extension ≥ 5mm)
    2.2. Or radiological intermediate risk (rT3 tumour with <5mm extramural extension) and younger age/good general health
    3. 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
    4. 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.
    5. Adequate renal biochemistry: GFR >50 ml/min calculated by the Wright or Cockroft formula or EDTA clearance >70 ml/min
    6. 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.)
    7. Aged 18 or over
    8. WHO performance status of 0, 1 or 2
    9. If female and of childbearing potential, must:
    9.1. Have a negative pregnancy test ≤72hours prior to initiating study treatment
    9.2. Agree to avoid pregnancy during and for 6 months after study treatment
    10. 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
    11. Patient able and willing to provide written informed consent for the study


    Previous 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 Exclusion Criteria
    Current exclusion criteria as of 26/01/2018:
    1. MorbidityAny patient for whom radiotherapy is advised by the MDT
    2. Strong evidence of distant metastases or peritoneal nodules (M1)
    3. Peritonitis (secondary to perforated tumour)
    4. Colonic obstruction that has not been defunctioned
    5. Serious medical comorbidity, eg uncontrolled inflammatory bowel disease, uncontrolled angina or recent (<6 months) MI
    6. Another serious medical condition judged to compromise ability to tolerate neoadjuvant therapy and/or surgery
    7. 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
    1. RAS-mutant or unknown RAS status tumours
    2. Allocated post-operative chemotherapy
    3. History of interstitial pneumonitis or pulmonary fibrosis
    4. History of severe or life-threatening hypersensitivity reactions
    5. Serum magnesium levels within the normal range at trial entry (which can include intravenous correction)

    Previous 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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Pfizer Investigational Site
Birmingham
B15 2TT
Trial Contact(s)
Primary Trial Contact
Dr Laura Magill
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Denmark, Sweden, United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Fluoropyrimidine, Oxaliplatin and Targeted Receptor pre-Operative Therapy: a controlled trial in high-risk operable colon cancer
EudraCT Number
2007-001987-55
Funder(s)
  • Cancer Research UK (CRUK) (UK)
Other Study ID Numbers
N/A
Sponsor(s)
University of Birmingham (UK)
Key Dates

Recruitment Start Date

01 Apr 2008

Recruitment End Date

23 Dec 2016

Trial Start Date

01 Jan 2007

Trial End Date

31 Dec 2019

Date added to source

30 Mar 2007

Date updated in source

26 Jan 2018