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

NCT02699073 | Completed Phase 2

• 1 other identifier: TEXCAN C15-2
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 8

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)

Conditions

Metastatic Colorectal Cancer

Keywords

colorectal cancer; metastatic; regorafenib; CHOI criteria; RECIST criteria

Outcome Measures

Primary Outcomes (1)

• Tumor response rate at 2 months according Choi Criteria

  2 months after the beginning of treatment

Secondary Outcomes (11)

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

  At 1 month and 2 months after the beginning of treatment

• Tumor response rate at 1 month according to Choi criteria

  At 1 month after the beginning of treatment

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

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

• Disease control rate (DCR)

  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

• Overall Survival (OS)

  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

Study Arms (1)

Regorafenib

EXPERIMENTAL

dose of regorafenib : 160mg once daily

Drug: regorafenib

Interventions

regorafenib DRUG

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.

Regorafenib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Adequate renal, bone marrow, liver and pancreatic functions:
• Estimated creatinine clearance ≥ 30 mL/min as calculated using the Cockcroft-Gault equation
• 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).

You may not qualify if:

• 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)
• 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
• 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

Sponsors & Collaborators

• GERCOR - Multidisciplinary Oncology Cooperative Group: lead

Study Sites (8)

CHU Jean Minjoz

Besançon, France

Location

Hôpitlal Henri Mondor

Créteil, France

Location

Institut Hospitalier Franco-Britannique

Levallois-Perret, France

Location

CHRU Claude Huriez

Lille, France

Location

ICM Val D'Aurelle

Montpellier, France

Location

Hôpital Pitié Salpêtrière

Paris, France

Location

Hôpital Saint Antoine

Paris, France

Location

Insitut Mutualiste Montouris

Paris, France

Location

Related Publications (2)

• 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.

  PMID: 35489233 DERIVED

• 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.

  PMID: 31818317 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Interventions

regorafenib

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thierry ANDRE, MD

  Hôpital Saint Antoine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: March 4, 2016
• Study Start: February 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: July 9, 2018
• Last Updated: February 28, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)