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

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ClinicalTrials.gov Identifier: NCT02699073
Recruitment Status : Completed
First Posted : March 4, 2016
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
GERCOR - Multidisciplinary Oncology Cooperative Group

Brief 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)


Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: regorafenib Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : July 9, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Regorafenib

Arm Intervention/treatment
Experimental: Regorafenib
dose of regorafenib : 160mg once daily
Drug: regorafenib

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.





Primary Outcome Measures :
  1. Tumor response rate at 2 months according Choi Criteria [ Time Frame: 2 months after the beginning of treatment ]

Secondary Outcome Measures :
  1. Tumor response rate at 1 and 2 months according to RECIST1.1 [ Time Frame: At 1 month and 2 months after the beginning of treatment ]
  2. Tumor response rate at 1 month according to Choi criteria [ Time Frame: At 1 month after the beginning of treatment ]
  3. Best overall response rate (BOR) according to Choi criteria and to RECIST 1.1 [ Time Frame: BOR is the best response recorded from the strat of treatment until treatment failure up to 36 months ]
  4. Disease control rate (DCR) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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). [ Time Frame: At 1 month after inclusion ]
  8. Evaluation of tumor heterogeneity with TexRAD software [ Time Frame: At baseline and 1 month after inclusion ]
    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).

  9. Serious adverse events( SAE) and adverse event (AE) [ Time Frame: Up to 36 months ]
    assessed by NCI-CTCAE4.0

  10. Identify early prognostic biomarkers of regorafenib [ Time Frame: 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) [ Time Frame: at baseline, Cycle 1 Day 15, cycle 2 Day 15 and end of treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed and dated informed consent.
  2. Patients with histologically proven metastatic colorectal cancer
  3. 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).
  4. ECOG PS = 0 or 1
  5. Aged 18-years or older
  6. Life expectancy of at least 3 months
  7. 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)
  8. 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
  9. At least one target lesion on CT scan
  10. No contraindication to Iodine contrast media injection during CT.
  11. 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
  12. 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
  13. Registration in a national health care system (CMU included).

Exclusion Criteria:

  1. 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
  2. Patients under judicial protection (curatorship, tutorship) and/or deprived of freedom
  3. Major surgical procedure, open biopsy or significant traumatic injury within 28 days before start of study medication
  4. Pregnancy or breastfeeding
  5. Congestive heart failure ≥ New York Heart Association (NYHA) class 2
  6. Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months)
  7. Myocardial infarction less than 6 months before the start of study medication
  8. Cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted)
  9. Uncontrolled hypertension (systolic blood pressure >140 mmHg or diastolic pressure >90 mmHg despite optimal medical management)
  10. 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
  11. Pleural effusion or ascites that causes respiratory compromise (≥ CTCAE grade 2, NCI-CTCAE v 4.0 dyspnea)
  12. Ongoing infection >grade 2, NCI- CTCAE v 4.0
  13. 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])
  14. Known history of human immunodeficiency virus (HIV) infection
  15. Active hepatitis B or C or chronic hepatitis B or C requiring treatment with antiviral therapy
  16. Patients with seizure disorder requiring medication
  17. History of organ allograft
  18. Patients with evidence or history of any bleeding diathesis, irrespective of severity
  19. Any hemorrhage or bleeding event ≥ Grade 3, NCI-CTCAE v 4.0 within 4 weeks prior to the start of study medication
  20. Non-healing wound, non-healing ulcer or non-healing bone fracture
  21. Dehydration grade ≥1, NCI-CTCAE v 4.0
  22. Known hypersensitivity to the study drug, study drug classes or excipient in the formulation
  23. Interstitial lung disease with ongoing signs or symptoms at the time of inclusion
  24. 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)
  25. Patients unable to swallow oral medication
  26. Any malabsorption condition
  27. Unresolved toxicity higher than Grade 1, NCI-CTCAE v 4.0, attributed to any prior therapy/procedure excluding alopecia and oxaliplatin induced neuropathy
  28. Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 3 weeks
  29. Treatment with any other investigational medicinal product within 28 days prior to study entry
  30. Chronic treatment potentially interacting with the study medication, i.e. strong CYP3A4 inducers/inhibitors, strong UGT1A9 inhibitors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699073


Locations
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France
CHU Jean Minjoz
Besançon, France
Hôpitlal Henri Mondor
Créteil, France
Institut Hospitalier Franco-Britannique
Levallois Perret, France
CHRU Claude Huriez
Lille, France
ICM Val D'Aurelle
Montpellier, France
Hôpital Pitié Salpêtrière
Paris, France
Hôpital Saint Antoine
Paris, France
Insitut Mutualiste Montouris
Paris, France
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
Investigators
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Principal Investigator: Thierry ANDRE, MD Hôpital Saint Antoine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GERCOR - Multidisciplinary Oncology Cooperative Group
ClinicalTrials.gov Identifier: NCT02699073    
Other Study ID Numbers: TEXCAN C15-2
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by GERCOR - Multidisciplinary Oncology Cooperative Group:
colorectal cancer
metastatic
regorafenib
CHOI criteria
RECIST criteria
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases