Aflibercept and 5-FU vs. FOLFOX as 1st Line Treatment for Elderly or Frail Elderly Patients With … (NCT03530267) | Clinical Trial Compass
CompletedPhase 2
Aflibercept and 5-FU vs. FOLFOX as 1st Line Treatment for Elderly or Frail Elderly Patients With Met. Colorectal Cancer
Germany124 participantsStarted 2018-09-28
Plain-language summary
This is a controlled, open-label, randomized phase- II trial (1:1 randomization) investigating 5-FU + aflibercept and 5-FU + oxaliplatin in elderly and frail elderly patients with mCRC scheduled to receive first line treatment.
Who can participate
Age range70 Years
SexALL
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Inclusion criteria
✓. To enter this trial the oncologist has to confirm, that the patient was in his or her opinion not a candidate for standard full-dose combination therapy. Moreover, the oncologist has to state the reason for entering the trial (Advanced age alone versus both 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 (\<80, 80 to 85, or 85 years). The total score can range from 0 to 17. The result on the G8 is considered abnormal if the score is ≤14, indicating a geriatric risk profile.
✓. Patients have to have histologically confirmed mCRC with unidimensionally measurable inoperable advanced or metastatic disease
✓. ECOG performance status of 2 or better.
✓. Life expectancy of 3 months or longer at enrolment
✓. Patients \>70 years with no upper age limit
✓. Previous adjuvant chemotherapy is allowed if completed more than 6 months before randomisation
✓. Previous rectal (chemo)radiotherapy is allowed if completed more than 6 months before randomisation
✓. Hematological status:
Exclusion criteria
✕. Prior systemic chemotherapy for mCRC
✕. Other concomitant or previous malignancy, except:
What they're measuring
1
Progression-free survival (PFS)
Timeframe: 6 months
Trial details
NCT IDNCT03530267
SponsorInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest