Resecable Metastatic Cororectal Cancer.
Conditions
Interventions
Trade Name: Eloxatin 5mg/ml
Product Name: Eloxatin 5mg/ml
Pharmaceutical Form: Solution for infusion
Trade Name: CAMPTO 20mg/ml
Product Name: CAMPTO 20mg/ml
Pharmaceutical Form: Concentrate for solut
Sponsors
Cliniques universitaires Saint-Luc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female or male patients with at least 18 years at the time the informed consent is signed 2. EGOG performance status 0 or 1 3. Histological or cytological confirmed diagnostic of adenocarcinoma of the colon or rectum, with or without primary tumour in situ. Wild-type or mutated KRAS tumor status. 4. Patients must present a resectable metastatic disease for which the decision of preoperative chemotherapy is considered. Resectability could be planned in one or multiple stage if indicated. As commonly admitted, resectability means the surgical clearance (+/- radiofrequency ablation) of all detectable (liver) lesions with tumor-free margins and compatible with an adequate hepatic reserve. 5. Partial and minor resection of metastatic disease is allowed within 3 months before inclusion if patient has never received chemotherapy for mCRC. 6. Extra hepatic metastatic location is limited to 1 site. Extra-hepatic location must be easily resectable in one stage surgery. 7. Patients may have received adjuvant chemotherapy or (neo-) adjuvant chemo-radiotherapy to the pelvis, provided the last dose of chemotherapy was administered at least 6 months prior to inclusion (12 months for oxaliplatin). Previous radiotherapy to the pelvis is not an exclusion criterion. 8. Adequate haematological, renal and hepatic function as follows: Haematological Neutrophils > 1.5 x 109/L Platelets > 100 x 109/L Renal Creatinine 150 mmHg and/or diastolic blood pressure > 100 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy. 11. Female patients must either be postmenopausal, sterile (surgically or radiation- or chemically-induced), or if sexually active using an acceptable method of contraception. 12. Male patients must be surgically sterile or if sexually active and having a pre-menopausal partner must be using an acceptable method of contraception. 13. Life expectancy of at least 3 months without any active treatment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Non resectable mCRC at diagnosis. 2. Prior chemotherapy or systemic therapy for mCRC. Adjuvant chemotherapy for colorectal cancer is not an exclusion criterion provided that it was completed more than 6 months prior to inclusion. Oxaliplatin-based chemotherapy must be completed more than 1 year prior to inclusion. 3. Prior utilization of bevacizumab, aflibercept (or other anti-VEGF therapy). 4. Previous radiotherapy delivered to the upper abdomen. 5. Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or thrombosis as determined by clinical or radiologic assessment. 6. Prior major liver resection: remnant liver < 50% of the initial liver volume. 7. Non-malignant disease that would render the patient unsuitable for treatment according to this protocol. 8. Concurrent central nervous systems metastases 9. Peripheric neuropathy = grade 2. 10. Interstitial lung disease 11. Pregnant or breast feeding. 12. The patient has previous or concomitant malignancies, except: Invasive malignancies in remission for more than 5 years and non melanoma skin cancer or carcinoma in situ of the cervix.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To analyze the pathological tumor response on resected colorectal cancer metastases after preoperative treatment with bevacizumab combined with FOLFOX or FOLFIRI regimen in a prospective cohort and to correlate this response with patient’s outcome.;Secondary Objective: •Major pathological response rate (MPRR), Progression Free Survival (PFS), Overall survival (OS), Clinical response rate at time of surgery, Metabolic response rate at time of surgery, pathological complete response (pCR), Curative resection rate (R0 resection). •One month surgical complication rate, Clinical toxicity, Chemotherapy-associated hepatotoxicity. ;Primary end point(s): Major pathological response rate (MPRR). MPRR is defined as the proportion of patients presenting a major pathological response. Pathologic response will be evaluated according the Rubbia-Brandt Tumor Regression Grade classification. For patients with multiple colorectal metastases the global pathological response will be categorized based on the mean TRG of all metastases: a major response is defined as a mean TRG <3, a partial response is defined by a mean TRG = 3 and < 4 and absence of response is characterized by a mean TRG = 4.;Timepoint(s) of evaluation of this end point: After 3 months of medical treatment (Chemotherapy), the surgery will be done to analysed the metastases. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Progression Free Survival (PFS), Overall survival (OS), Pathological complete response (pCR), Clinical response rate at time of surgery, Metabolic response rate at time of surgery, Curative resection rate, Toxicity;Timepoint(s) of evaluation of this end point: Depending of the patient survival | — |
Countries
Belgium
Contacts
Public ContactCentre du Cancer
Cliniques universitaires Saint-Luc
Outcome results
None listed