metastatic colorectal cancer
Conditions
Interventions
ARM A: Modified LV5FU2 as described below (6.2.1) D1-2 +/- bevacizumab 5 mg/kg
over 30 min or +/- cetuximab 250 mg/m² weekly or 500 mg/m² biweekly or +/-
panitumumab 6 mg/kg (according its previous
Sponsors
UZ Antwerpen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide written informed consent 2. Histologically confirmed adenocarcinoma of the colon or rectum, with or without primary tumour in situ. Unequivocal and measurable (RECIST 1.1) CT evidence of liver metastases which are not treatable by surgical resection or local ablation with curative intent at the time of trial entry. 3. Partial response or stable disease (RECIST 1.1 criteria, controlled metastatic disease) after chemotherapy induction with oxaliplatin and/or irinotecan- based induction chemotherapy (doublet or triplet combinations) +/- targeted therapies during 3 to 6 months. 4. Trial inclusion must be performed between 3 and 6 months since the date of the first course of chemotherapy (induction) administration. 5. Limited extra-hepatic metastases in the lung and/or lymph nodes are permitted. Metastases in the lung must either be not more than five nodules in number with no nodule more than 1 cm in diameter or 1 single lesion of up to 1.7 cm in diameter. Involvement of lymph nodes in 1 single anatomic region (pelvis, abdomen or chest) are permitted provided their longest diameter measures less than 2 cm. 6. All imaging evidence used as part of the screening process must be within 28 days prior to randomisation. 7. Suitable for either treatment regimen as determined by clinical assessment undertaken by the Investigator. 8. 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 begin chemotherapy induction. Previous radiotherapy to the pelvis is not an exclusion criterion. 9. WHO performance status 0 * 1 10. Adequate haematological, renal and hepatic function as follows: Haematological Neutrophils > 1.5 x 109/L Platelets > 100 x 109/L Renal Creatinine
Exclusion criteria
Exclusion criteria: 1. Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or thrombosis as determined by clinical or radiologic assessment. 2. More than 6 weeks since the last chemotherapy administration before trial inclusion. 3. Previous radiotherapy delivered to the upper abdomen. 4. Non-malignant disease that would render the patient unsuitable for treatment according to this protocol. 5. Prior major liver resection: remnant liver 80% before study inclusion (not at diagnosis but when trial inclusion for the patent is planned). 7. Resectable metastatic disease at trial inclusion. 8. Progressive disease during first-line metastatic chemotherapy. Adjuvant chemotherapy for colorectal cancer is not an exclusion criterion provided that it was completed more than 6 months prior to start of 1st line therapy. 9. No oxaliplatin or irinotecan use during the first 3 to 6 months induction chemotherapy. 10. Pregnant or breast feeding. 11. Concurrent or prior history of cancer other than adequately treated non melanoma skin cancer or carcinoma in situ of the cervix 12. Severe allergy to non-ionic contrast agents which would prevent contrast media use during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end-points: - Time to first progression (TTP1 overall) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end-points: - Time to global progression (TTP1 + TTP2), Time to second progression (TTP2), TTP1 liver only - Progression Free Survival (PFS) - Overall Survival (OS) - Safety - Ro resection rate - Quality of Life Exploratory analysis: - Prediction and evaluation of SIR-Spheres treatment response (only for Belgian centres) | — |
Countries
Netherlands
Outcome results
None listed