Conversion From Unresectable To Resectable Metastatic Colorectal Cancer.
ConditionMetastatic Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Saskatchewan
About this trial
Most patients with mCRC are treated with palliative chemotherapy and only a small number of patients with limited metastatic disease achieve long-term remission following metastasectomy. There is a growing need for more effective treatment in patients with liver-only mCRC to improve the rate of curative resection without compromising QOL.The current study is informed by our patient's needs. It aims to evaluate the rate of conversion therapy in patients with unresectable liver-only mCRC using the combination of FOLFOXIRI and bevacizumab and to assess the association between an early FDG-PT/CT response and other clinical and pathological biomarkers and hepatic metastasectomy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients, aged between 18 and 70 years with histologically proven adenocarcinoma or poorly differentiated carcinoma of the colon and rectum with unresectable liver-only metastases and no extra-hepatic disease.
World Health Organization (WHO) performance status of 0-1.
No previous chemotherapy for advanced disease.
Adequate functioning of the bone marrow, liver, and kidneys.
Disqualifiers
Breastfeeding or pregnancy.
An active second primary cancer with the exception of squamous cell carcinoma of the skin or an in situ cancer.
Severe or uncompensated concomitant medical conditions.
Trial design
Design model
Single group
Treatments tested in this trial
FOLFOXIRI and Bevacizumab
DrugEvery 2 week for a total of 12 cycles
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: Single armOther 1 intervention
Trial outcomes
Primary outcomes
1
Rate of liver metastasectomy
Conversion From Unresectable To Resectable Liver Metastases
Time frame
Up to 3 years from the date of enrolment into the studySecondary outcomes
1
Response rate
Based on RECIST criteria
Time frame
Up to 12 weeks of last cycle of FOLFOXIRI from the date of enrolment till the date of maximum response2
30 days rates of Grade III and IV toxicity
As per National Cancer Institute Common Toxicity Criteria
Time frame
Up to 30 days of last cycle of FOLFOXIRI from the date of enrolment till the date of toxicity3
The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30)
Quality of life questionnaire related to cancer and its treatment
Time frame
up to 3 years from the date of enrolment or till the progression of the disease4
The European Organization for Research and Treatment of Cancer (EORTC) Colorectal Cancer Module (QLQ-CR29)
Quality of life questionnaire specifically related to colorectal cancer
Time frame
up to 3 years from the date of enrolment or till the progression of the diseaseSponsors and contacts
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Source ClinicalTrials.gov