Participant flow

Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies · Source last updated 2024-09-19

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Participants received TAS-102 orally with a starting dose of 35 milligram per meter square per dose (mg/m\^2/dose) twice daily (BID) based on body surface area (BSA) along with best supportive care (BSC). The first dose of TAS-102 was administered in the morning of Day 1 of each cycle and the last dose was administered in the evening of Day 5, followed by rest on Day 6 and 7. The treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle = 28 days). Participants received study medication until any of the discontinuation criteria were met.

   id

   FG000

   title

   TAS-102

2. description

   Participants orally received TAS-102 matching placebo BID dose along with BSC with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5, followed by rest on Day 6 and 7. The treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle). Participants received study medication until any of the discontinuation criteria.

   id

   FG001

   title

   Placebo

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Not treated

   2. reasons

      1. group Id

         FG000

         num Subjects

         367

      2. group Id

         FG001

         num Subjects

         211

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Participant refusal

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         534

      2. group Id

         FG001

         num Subjects

         266

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         533

      2. group Id

         FG001

         num Subjects

         265

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         162

      2. group Id

         FG001

         num Subjects

         51

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         372

      2. group Id

         FG001

         num Subjects

         215

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Total 1002 participants provided consent, out of which 800 participants were randomized in 2:1 ratio in TAS-102 and placebo treatment groups respectively.

recruitment Details

This was a multicenter study conducted in 101 study centers in 13 countries including the United States, Japan, Spain, Italy, Germany, Belgium, France, Australia, United Kingdom, Austria, Ireland, Sweden, and Czech Republic.

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Preserved source evidence · Independent clinical review pending · Not medical advice