Observational Study on Second Line Treatment of Liver Metastases With DEBIRI and Cetuximab
Condition: Colon Cancer Liver Metastasis
MeSH terms: Neoplasm Metastasis; Colonic Neoplasms; Liver Neoplasms
Study type: Observational [Patient Registry]

Summary: 
      -  The recently introduced chemoembolization has been considered to be a very attractive
           new method in terms of response in the treatment of liver metastases from colon cancer
           carcinoma (LM-CRC). It appears to be particularly useful if carried out with the new
           embolization materials.

        -  An 80% response rate was reported using TACE with Irinotecan pre-loaded Beads in
           patients with liver metastases from colon cancer, who had been pretreated with 2 or more
           lines of chemotherapy.

        -  Since a greater activity was attained by a combination of Cetuximab and Irinotecan
           versus Cetuximab in monotherapy, the European Agency for the Evaluation of Medicinal
           Products (EMEA) has granted authorization to the use of Cetuximab in association with
           irinotecan in the treatment of irinotecan-refractory CRC-LM.

        -  In this study we want to collect data on on time to progression and tolerability using
           DEBIRI+Cetuximab in LM-CRC
    

Detailed description: 
      This is an observational study and the treatment is related to the experiences and economical
      availability of each center.

      Primary objective: To collect data on time to progression (local and/or distant progression)
      after administration of Dc-Beads microspheres preloaded with Irinotecan 200 mgr via hepatic
      intra-arterial locoregional delivery (TACE) in/without association with standard weekly
      therapy with Cetuximab.

      Secondary objectives: To collect data on tolerability of treatment and improvement of quality
      of life (Edmonton Symptom Assessment System (ESAS))

      Treatment under observation :

      Program A ( for all patients)

      Day +1:

      Lobar Infusion (lobe with dominant disease) of Irinotecan 100 mg preloaded into 2 ml of
      70-150 µm M1 microspheres.

      Second lobar infusion of Irinotecan 100 mg preloaded into 2 ml of 70-150 µm M1 microspheres
      can be administered at the same time contralaterally or in a further TACE.

      Day +30: The above procedure is repeated. Day +90: In case of response, a third
      administration following the above procedures will be repeated

      Program B ( for Centers in which Cetuximab is available) 5.2 Cetuximab administered as per
      standard scheme: Day -15: loading dose with 400 mg/mq i.v. over a 2-hour period Day +21 and
      subsequent weekly administrations: 250 mg/mq i.v. over a one hour period.

      It is pointed out that administration of Cetuximab will be continued following the timeline
      of the first infusion relative to the intra-arterial administration.

      Evaluation of response

      Response must be assessed by repeating the following examinations at Day 30, Day 90 and Day
      120 after start of treatment:

      Chest-abdomen CAT scan with and without contrast medium (refer to Section 4). Evaluation will
      be based on the Response Evaluation Criteria In Solid Tumors (RECIST) cancer markers (CEA,
      Carbohydrate Antigen (CA) 19.9)

      Assessment of quality of life The Edmonton Symptom Assessment System (ESAS) is used to
      monitor health conditions and quality of life.

      The questionnaire must be filled in by the patient unaided by family members or by health
      care personnel, over a period of about 15 minutes. Assessment of quality of life will be
      performed during the baseline visit and at Day 30, Day 60 and Day 120 from start of
      treatment.

      It is important for the questionnaire to be completed by the patient before undergoing the
      physical examination, in other words before discussing with the physician about any
      examinations which might give an indication of the favorable or unfavorable course of the
      disease. In providing the questionnaire to the patient, the physician will explain how to
      complete it without discussing the contents of the questions, and once the patient has
      completed the questionnaire, the physician will check that all questions have been answered.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        primary care clinic
      
Keywords: Colon Cancer, Liver Metastasis, DEBIRI, cetuximab, efficacy