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COLON ERDERLY LOW DOSE

ConditionColon Adenocarcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age70-99
SponsorMatteo Clavarezza

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with metastatic colorectal adenocarcinoma not treated with any therapy in the metastatic phase. Previous (neo)-adjuvant treatment with fluoroderivatives with or without Oxaliplatin is permitted.

Age ≥ 70 years

G8 score ≥ 12

Patients with colorectal adenocarcinoma MSS

Disqualifiers

Patients with MSI tumours

Patients with BRAF V600E mutated tumours

Patients not eligible for doublet chemotherapy by clinical decision

Trial population

The study population includes patients aged 70 years and older, with metastatic colorectal adenocarcinoma, MSS, BRAF WT, with a G8 score greater than or equal to 12, candidates for metastatic first-line treatment

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

51 Participants
are grouped into 1 trial group
Group A: Retrospective

Trial outcomes

Primary outcomes

1

Neutropenia incidence

overall incidence of grade 4 neutropenia or febrile neutropenia of less than 8%

Time frame
24 months
2

Diarrehea incidence

incidence of grade 3-4 diarrhea of less than 8%.

Time frame
24 months

Secondary outcomes

1

PFS

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
2

OS

Overall Survival (OS), which is the time between the date of cycle day 1 of treatment and death

Time frame
24 months
3

differences in toxicity of anti-VEGF monoclonal antibodies

Assess toxicity between in ANTI-VEGF monoclonal antibodies

Time frame
24 months
4

differences in toxicity of anti-EGFR monoclonal antibodies

Assess toxicity between in ANTI-EGFR monoclonal antibodies

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Matteo Clavarezza

Lead sponsor

Ente Ospedaliero Ospedali Galliera

Sponsor institution

Source ClinicalTrials.gov
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