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Metastatic Colorectal CancerPhase 2TEXCANNCT02699073

Evaluation of Treatment Response With CHOI and RECIST Criteria and CT Texture Analysis in Patients With Metastatic Colorectal Cancer Treated With Regorafenib

A Phase 2 study testing regorafenib in people with Metastatic Colorectal Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 8 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to evaluate the performance of various tumor response criteria (Choi and RECIST1.1 criteria) in the assessment of regorafenib activity. Moreover, an assessment of the tumor heterogeneity will be made using computed tomographic texture analysis (CTTA) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
regorafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
8 sitesFrance
Study dates
Feb 2016to 9 Jul 2018
Phase
Phase 2
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

  • Signed and dated informed consent.
  • Patients with histologically proven metastatic colorectal cancer
  • Patients previously treated with, or who are not considered candidates for available therapies, i.e., fluoropyrimidine-based chemotherapy, anti-VEGF therapy and anti-EGFR therapy (if patients were RAS wild-type).
  • ECOG PS = 0 or 1
  • Aged 18-years or older
  • Life expectancy of at least 3 months
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  • Adequate renal, bone marrow, liver and pancreatic functions:
  • Estimated creatinine clearance ≥ 30 mL/min as calculated using the Cockcroft-Gault equation
  • Platelet count ≥ 100.000/mm3; hemoglobin ≥ 9 g/dL; absolute neutrophil count ≥ 1500/mm3. Transfusion to meet the inclusion criteria will not be allowed
  • Total bilirubin ≤ 1.5 the upper limit of normal value (ULN); alanine aminotransferase (ALAT) and aspartame aminotransferase (ASAT) ≤ 3.0 x ULN (≤ 5.0 x ULN for patients with liver involvement of their cancer); alkaline phosphatase (ALP) ≤ 2.5 x ULN (≤ 5.0 x ULN for patients with liver involvement of their cancer and/or have bone metastases)
  • International normalized ratio (INR) ≤ 1.5 x ULN and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless receiving treatment with therapeutic anticoagulation. Patients being treated with anticoagulant, e.g., heparin, will be allowed to participate provided no prior evidence of an underlying abnormality in these parameters exists. Close monitoring of at least weekly evaluation will be performed until INR and PTT are stable based on a pre-dose measurement as defined by the local standard of care
  • At least one target lesion on CT scan
  • No contraindication to Iodine contrast media injection during CT.
  • For women of childbearing potential, blood or urine pregnancy test performed a maximum of 7 days before start of study treatment and negative result documented before start of study treatment
  • When applicable, i.e., women of childbearing potential having sexual activity, men having sexual activity, must agree to use an adequate contraception before entering the study, until at least 8 weeks after the last study drug administration
  • Registration in a national health care system (CMU included).

Who cannot join

  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before inclusion in the trial ; planned surgical procedure within the first month of treatment or any procedure that might change the timing of regorafenib administration during the first month of treatment
  • Patients under judicial protection (curatorship, tutorship) and/or deprived of freedom
  • Major surgical procedure, open biopsy or significant traumatic injury within 28 days before start of study medication
  • Pregnancy or breastfeeding
  • Congestive heart failure ≥ New York Heart Association (NYHA) class 2
  • Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months)
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  • Myocardial infarction less than 6 months before the start of study medication
  • Cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted)
  • Uncontrolled hypertension (systolic blood pressure >140 mmHg or diastolic pressure >90 mmHg despite optimal medical management)
  • Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before the start of study medication (except for adequately treated catheter-related venous thrombosis occurring more than one month before the start of study medication
  • Pleural effusion or ascites that causes respiratory compromise (≥ CTCAE grade 2, NCI-CTCAE v 4.0 dyspnea)
  • Ongoing infection >grade 2, NCI- CTCAE v 4.0
  • Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to inclusion, except for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors (Ta [non-invasive tumor], Tis [carcinoma in situ] and T1 [tumor invades lamina propria])
  • Known history of human immunodeficiency virus (HIV) infection
  • Active hepatitis B or C or chronic hepatitis B or C requiring treatment with antiviral therapy
  • Patients with seizure disorder requiring medication
  • History of organ allograft
  • Patients with evidence or history of any bleeding diathesis, irrespective of severity
  • Any hemorrhage or bleeding event ≥ Grade 3, NCI-CTCAE v 4.0 within 4 weeks prior to the start of study medication
  • Non-healing wound, non-healing ulcer or non-healing bone fracture
  • Dehydration grade ≥1, NCI-CTCAE v 4.0
  • Known hypersensitivity to the study drug, study drug classes or excipient in the formulation
  • Interstitial lung disease with ongoing signs or symptoms at the time of inclusion
  • Persistent proteinuria >3.5 g/24 hour measured by urine protein-creatinine ratio from a random urine sample (≥ Grade 3, NCI-CTCAE v 4.0)
  • Patients unable to swallow oral medication
  • Any malabsorption condition
  • Unresolved toxicity higher than Grade 1, NCI-CTCAE v 4.0, attributed to any prior therapy/procedure excluding alopecia and oxaliplatin induced neuropathy
  • Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 3 weeks
  • Treatment with any other investigational medicinal product within 28 days prior to study entry
  • Chronic treatment potentially interacting with the study medication, i.e. strong CYP3A4 inducers/inhibitors, strong UGT1A9 inhibitors

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

France8 sites

  • CHU Jean Minjoz

    Besançon

  • Hôpitlal Henri Mondor

    Créteil

  • Institut Hospitalier Franco-Britannique

    Levallois-Perret

  • CHRU Claude Huriez

    Lille

  • ICM Val D'Aurelle

    Montpellier

  • Hôpital Pitié Salpêtrière

    Paris

  • Hôpital Saint Antoine

    Paris

  • Insitut Mutualiste Montouris

    Paris

Other trials in France

About this study

Official title: Evaluation of Treatment Response With CHOI and RECIST Criteria and CT Texture Analysis in Patients With Metastatic Colorectal Cancer Treated With Regorafenib. A GERCOR Phase II Study

The purpose of the study is to evaluate the performance of various tumor response criteria (Choi and RECIST1.1 criteria) in the assessment of regorafenib activity.

Moreover, an assessment of the tumor heterogeneity will be made using computed tomographic texture analysis (CTTA)

Read the detailed description

This is a phase II study in patients with metastatic colorectal cancer treated by regorafenib.

Being tested
regorafenib
Keywords
colorectal cancer, metastatic, regorafenib, CHOI criteria, RECIST criteria
Medical subject headings
Colorectal Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • regorafenibDrug

    160mg once daily during 3 weeks followed by 1 week off therapy.

    Regorafenib will be taken until disease progression according to the CHOI and RECIST1.1 criteria, death or inacceptable toxicity.

Study groups in NCT02699073
Study groupRoleWhat they receive
RegorafenibExperimentaldose of regorafenib : 160mg once daily
Receives: Drug: regorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tumor response rate at 2 months according Choi Criteria

    Measured: 2 months after the beginning of treatment

Secondary outcomes (11)

  1. Tumor response rate at 1 and 2 months according to RECIST1.1

    Measured: At 1 month and 2 months after the beginning of treatment

  2. Tumor response rate at 1 month according to Choi criteria

    Measured: At 1 month after the beginning of treatment

  3. Best overall response rate (BOR) according to Choi criteria and to RECIST 1.1

    Measured: BOR is the best response recorded from the strat of treatment until treatment failure up to 36 months

  4. Disease control rate (DCR)

    Measured: DCR is the proportion of patient with tumor response (CR or RP) or tumor stabilization as best response from the inclusion until treatment failure, up to 36 months

  5. Overall Survival (OS)

    Measured: Assessed from the date of study drug start to the date of patient death, due to any cause or to the last date the patient was known to be alive, up to 36 months

  6. Progression free survival (PFS)

    Measured: PFS is the time from the date of study drug start to the date of progressive disease or death due to any cause, up to 36 months

  7. Specificity of Choi criteria at 1 month in identifying patients with long or short OS (using median OS as cut-off value).

    Measured: At 1 month after inclusion

  8. Evaluation of tumor heterogeneity with TexRAD software

    Threshold of the CTTA parameters (Skewness, Kurtosis, Entropy, Uniformity) provided by the TexRAD software at baseline and optimal variations of these parameters on the CT performed at one month (compared to baseline).

    Measured: At baseline and 1 month after inclusion

  9. Serious adverse events( SAE) and adverse event (AE)

    assessed by NCI-CTCAE4.0

    Measured: Up to 36 months

  10. Identify early prognostic biomarkers of regorafenib

    Measured: at baseline, Cycle 1 Day 15, cycle 2 Day 15 and end of treatment

  11. Correlation between Baseline cell free DNA and survival outcomes (PFS and OS)

    Measured: at baseline, Cycle 1 Day 15, cycle 2 Day 15 and end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionDec 2017
  4. Study completion9 Jul 2018

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02699073
Sponsor's protocol ID
TEXCAN C15-2
Acronym
TEXCAN
Status last verified
Feb 2019
First submitted
23 Feb 2016
Last updated
28 Feb 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Rousseau B, Boukerma AK, Henriques J, Cohen R, Lucidarme O, Borg C, Tournigand C, Kim S, Bachet JB, Mazard T, Louvet C, Chibaudel B, Vernerey D, Andre T, Hulin A. Impact of trough concentrations of regorafenib and its major metabolites M-2 and M-5 on overall survival of chemorefractory metastatic colorectal cancer patients: Results from a multicentre GERCOR TEXCAN phase II study. Eur J Cancer. 2022 Jun;168:99-107. doi: 10.1016/j.ejca.2022.03.009. Epub 2022 Apr 27.

    PubMed 35489233

  • Lucidarme O, Wagner M, Gillard P, Kim S, Bachet JB, Rousseau B, Mazard T, Louvet C, Chibaudel B, Cohen R, Garcia-Larnicol ML, Gobert A, Henriques J, Andre T. RECIST and CHOI criteria in the evaluation of tumor response in patients with metastatic colorectal cancer treated with regorafenib, a prospective multicenter study. Cancer Imaging. 2019 Dec 9;19(1):85. doi: 10.1186/s40644-019-0271-z.

    PubMed 31818317

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing regorafenib in people with Metastatic Colorectal Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 8 sites in France.

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 30 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: finished, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in France. 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 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Tumor response rate at 2 months according Choi Criteria (time frame: 2 months after the beginning of treatment). 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 NCT02699073, which also lists 2 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 28 Feb 2019.

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