Your journey
1What's a trial
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More info
You can access this
clinical trial
if you have
Metastatic Colorectal Cancer
and you are
over 18
years old
This is a second phase trial assessing
efficacy and side effects of the new treatment.
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The purpose

Open-label, randomized, multicenter, Phase II trial designed to estimate the efficacy of CAPTEM versus FOLFIRI as second line treatment in MGMT methylated, RAS mutated advanced CRC patients who have progressed on or after first-line oxaliplatin containing chemotherapy for metastatic disease. MGMT will be assessed centrally at Pathology Department of Fondazione IRCCS Istituto Nazionale dei Tumori prior to enrollment. A minimum of ten 3-micron unstained sections on charged slides of tumor will be required and methylation status will be provided within a maximum of seven days to the Study Centers. Presence of RAS mutation will be assessed at each local participating center. Eligible patients will be randomized in a 1:1 ratio to one of two treatment arms: - Arm A (experimental arm): CAPTEM - Arm B (control arm): FOLFIRI Study treatment will be given in cycles repeated every 28 days for Arm A and every 14 days for Arm B. Patients in Arm A will receive capecitabine at the oral dose of 1500 mg/mq/die bid from day 1 to day 14 every 28 days plus temozolomide 150 mg/mq/die bid starting on day 9 to 14 every 28 days. Patients in Arm B will receive FOLFIRI chemotherapy starting Day 1 q2w (every cycle) starting on Day 1 of Cycle 1. FOLFIRI consists of irinotecan (starting dose of 180 mg/m2) on day one only; 5-FU 7 (starting bolus and 22-hour infusional doses of 400 mg/m2 and 600 mg/m2, respectively), and leucovorin (racemic, starting dose of 200 mg/m2 or L-form, starting dose of 100 mg/m2) for two consecutive days. Treatment will continue for up to 6 cycles in Arm A and up to 12 cycles in Arm B or up to disease progression, unacceptable toxicity or informed consent withdrawal. Randomization will be stratified across the treatment arms by the following predefined stratification variables: disease progression within 9 months from the start of first-line oxaliplatin-containing chemotherapy (< vs. ≥9 months); prior bevacizumab in combination with oxaliplatin-based chemotherapy (yes vs. no). Efficacy assessments will be performed every 2 cycles in Arm A and every 4 cycles in Arm B until progression. The study is expected to enrol approximately 82 patients who meet the eligibility criteria.

Provided treatments

  • Drug: Capecitabine
  • Drug: Temozolomide
  • Drug: Irinotecan
  • Drug: Fluorouracil
  • Drug: Leucovorin
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Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT02414009. The sponsor of the trial is Fondazione IRCCS Istituto Nazionale dei Tumori, Milano and it is looking for 82 volunteers for the current phase.
Official trial title:
Open-label, Randomized, Multicenter, Phase II Trial to Compare Efficacy of CAPTEM Versus FOLFIRI as Second Line in Patients Progressed on or After First-line Oxaliplatin Chemo for Advanced, MGMT Methylated, RAS Mutated Colorectal Cancer