A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)
NCT06997497
Colon Adenocarcinoma, Colonic Diseases
Los Angeles, California, United States
View Trial DetailsNCT Number: NCT06840977
In this retrospective observational study, the case series of patients undergoing first-line treatment for metastatic colorectal adenocarcinoma with doublet fixed-dose and reduced-dose chemotherapy in combination with full-dose monoclonal antibody in patients aged 70 years or older is collected.
Interested in participating?
Request Info70 year–99 year
All sexes
Observational
E.O. Ospedali Galliera, Genova, GE, Italy
Treatment in the elderly first-line patient of metastatic colorectal cancer is often conditioned by the age and general condition of the patient.
Such treatment involves the combination of chemotherapy and biological therapy targeted on the basis of the site and genetic mutations of the colorectal tumour, in particular RAS and BRAF.
With regard to targeted biologic therapy, the choice of monoclonal antibody is determined by tumour site and mutations. In particular, for right-sided and/or RAS/BRAF mutated tumours anti-VEGF therapy with Bevacizumab is the best option, whereas for left-sided and RAS/BRAF WT tumours monoclonal antibodies Panitumunab or Cetuximab are the choice.
In the elderly patient, the intensity of chemotherapy to be combined with targeted biologic therapy varies according to the patient's age, general condition and treatment goals. In particular for patients aged 70 years or older, a valid option is the combination of monochemotherapy with fluorodrugs in combination with bevacizumab. In addition, an Italian randomised trial tested monochemotherapy with 5-Fluorouracil in combination with Panitumumab in RAS WT/BRAF WT tumours and obtained the same efficacy as a doublet of chemotherapy with FOLFOX also in combination with Panitumumab.
Full-dose doublet chemotherapy is hardly feasible in the elderly patient because of the frailty of these patients and the high risk of toxicity.
In this retrospective observational study, we report on the case series of patients undergoing first-line treatment for metastatic colorectal adenocarcinoma with doublet of fixed-dose and reduced-dose chemotherapy in combination with full-dose monoclonal antibody in patients 70 years of age and older.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 24 months
overall incidence of grade 4 neutropenia or febrile neutropenia of less than 8%
Time frame: 24 months
incidence of grade 3-4 diarrhea of less than 8%.
Time frame: 24 months
Progression Free Survival (PFS), i.e. the time from day 1 of cycle 1 of treatment to the date of progression or death, whichever occurs first
Time frame: 24 months
Overall Survival (OS), which is the time between the date of cycle day 1 of treatment and death
Time frame: 24 months
Assess toxicity between in ANTI-VEGF monoclonal antibodies
Time frame: 24 months
Assess toxicity between in ANTI-EGFR monoclonal antibodies
Contact information is provided by the study sponsor or research team.
Matteo Clavarezza
Other
RETROSPECTIVE OBSERVATIONAL STUDY OF CHEMOTHERAPY IN ELDERLY PATIENTS IN THE FIRST-LINE TREATMENT OF METASTATIC COLORECTAL CANCER
Acronym: CELOW
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