metastatic colorectal cancer MedDRA version: 21.0 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. To enter this trial, the oncologist has to confirm that the reason for entering the trial was advanced age alone or age and frailty. As an operational definition for frailty the G8 screening tool will be used upon inclusion of the patient in a standardized manner. Briefly, G8 is an established screening tool that includes seven items from the Mini Nutritional Assessment (MNA) and an age-related item (=65 years) yes F.1.3.1 Number of subjects for this age range 124
Exclusion criteria
Exclusion criteria: 1. Prior systemic chemotherapy for mCRC 2. Other concomitant or previous malignancy, except: • Adequately treated in-situ carcinoma of the uterine cervix • Basal or squamous cell carcinoma of the skin • Cancer in complete remission for >3 years 3. Any other serious and uncontrolled non-malignant disease, major surgery or traumatic injury within the last 28 days before start of study treatment. 4. History or evidence upon physical examination of CNS metastasis unless adequately treated (irradiation and no seizure with appropriate treatment) 5. Uncontrolled hypercalcemia 6. Pre-existing peripheral neuropathy (NCI grade =2) resulting from previous therapy 7. Concomitant protocol unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy), 8. Treatment with any other investigational medicinal product within 28 days prior to study treatment. 9. Significant cardiovascular disease: • Cardiovascular accident or myocardial infarction or unstable angina =6 months before start of study treatment • Severe cardiac arrhythmia • New York Heart Association grade =2 congestive heart failure • Uncontrolled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy. • History of stroke or transient ischemic attack =6 months before start of study treatment • Coronary/peripheral artery bypass graft =6 months before start of study treatment. • Deep vein thrombosis or thromboembolic events =1 month before start of study treatment 10. Patients with known allergy to any excipient to study drugs, 11. Any of the following within 3 months prior to randomization: Grade 3-4 gastrointestinal bleeding/hemorrhage, treatment resistant peptic ulcer disease, erosive oesophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism or other uncontrolled thromboembolic event. 12. Bowel obstruction before start of study treatment. 13. Treatment with CYP3A4 inducers unless discontinued > 7 days prior to randomization 14. Known dihydropyrimidine dehydrogenase (DPD) deficiency 15. Involvement in the planning and/or conduct of the study (applies to both Sanofi staff and/or staff of sponsor and study site) 16. Patient who might be dependent on the sponsor, site or the investigator 17. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 S. 3 Nr. 4 AMG. 18. Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [§ 40 Abs. 1 S. 3 Nr. 3a AMG].
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the rates of progression-free survival at six months calculated from the start of treatment in elderly / frail elderly patients with metastatic colorectal cancer undergoing a 1st line treatment.;Secondary Objective: To compare the treatment arms with respect to: Safety -Dose intensities of study medication -Type, incidence and severity of AEs and SAEs -Laboratory parameters Efficacy -Response rate assessed by the local investigators -Overall and progression-free survival Patient reported outcomes -Quality of life -Geriatric assessment -Overall treatment utility ;Primary end point(s): Rate of patients free of progression at the time point of 6 months calculated from the start of treatment. Response assessment will be done in a standardized manner using CT scan. ;Timepoint(s) of evaluation of this end point: at 6 months calculated from the start of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety • Dose intensities of study medication • Type, incidence and severity of AEs, SAEs (CTCAE version 4.03) • Dose reduction or discontinuation of study drug due to adverse events • Rate of treatment discontination due to toxicity • Type, incidence and severity of laboratory abnormalities Efficacy • Response rates (response will be assessed by the local investigator using RECIST criteria v. 1.1; CT scans are conducted at 2, 4 and 6 months and every two months thereafter) • Overall and progression-free survival (OS) Patient reported outcomes • Quality of life using EQ5D • Geriatric assessment using G8, ADL and IADL • Overall treatment utility (as defined in FOCUS2 trial) ;Timepoint(s) of evaluation of this end point: - Safety and tolerability: continuously - Response Rate (ORR): at 2, 4 and 6 months and every two months thereafter - Overall survival (OS) and Progression-free Survival (PFS): continuously - Patient reported outcomes: QoL baseline and every 4 weeks; geriatric assessment: baseline, after 3 and 6 months; OTU: after 3 and 6 months | — |
Countries
Germany
Contacts
Public ContactIKF
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Outcome results
None listed