Trial · NCT04450836
Sequences Of REGorafenib And Trifluridine/Tipiracil in Patients With Metastatic Colorectal Cancer
NCT04450836, Phase 2, Terminated, UNICANCER
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sequences Of REGorafenib And Trifluridine/Tipiracil in Patients With Metastatic Colorectal Cancer. Trials, record NCT04450836. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04450836
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sequences Of REGorafenib And Trifluridine/Tipiracil in Patients With Metastatic Colorectal Cancer
- NCT number
- NCT04450836
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 234 participants, actual
- Lead sponsor
- UNICANCER
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Regorafenib then Trifluridine/Tipiracil, Trifluridine/Tipiracil then Regorafenib
- First posted
- 2020-06-30
- Last updated
- 2025-03-30
- Other registries' IDs
- eudract:2019-004196-39
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To evaluate the feasibility of treatment sequence (R-TT or TT-R) | Expected duration of 5 months from randomization | The feasibility of the treatment sequence is defined as the percentage of subjects able to receive both regorafenib and trifluridine/tipiracil according to the sequence in 3rd and 4th line. Subjects will be considered as having received both 3rd and 4th lines if they are administered at least two cycles of each line of therapy, i.e. percentage of patients being treated until the first tumor evaluation. |
| Secondary | To evaluate the efficacy of treatment sequence (R-TT or TT-R) in terms of Overall Survival rate | Expected duration of 9 months from randomization | Overall Survival (OS) is defined as the time interval from randomization until death from any cause. |
| Secondary | To evaluate the efficacy of treatment sequence (R-TT or TT-R) in terms of the progression-free Survival 1 (PFS1) | Expected duration of 3 months from randomization | Progression-free survival 1 (PFS1) is defined as the time interval from randomization until death or the disease progression observed in the first sequence of treatment in each arm, evaluated using Response evaluation criteria in solid tumors (RECIST) v1.1. |
| Secondary | To evaluate the efficacy of treatment sequence (R-TT or TT-R) in terms of the Progression-free survival 2 (PFS2) | Expected duration of 6 months from randomization | Progression-free survival 2 (PFS2) is defined as the time interval from randomization until death or the disease progression is observed in the later sequence of treatment in each arm, evaluated using RECIST v1.1. |
| Secondary | To evaluate the efficacy of treatment sequence (R-TT or TT-R) in terms of the Disease control rate (DCR) | Expected duration of 6 months from randomization | Disease control rate (DCR) is defined as percentage of patients with a best response that is not progressive disease (PD) (either complete response \[CR\], partial response \[PR\], or stable disease \[SD\]) during treatment. DCR will be assessed in each study arm. |
| Secondary | To evaluate the efficacy of treatment sequence (R-TT or TT-R) in terms of the Objective response rate (ORR) | Expected duration of 6 months from randomization | Objective response rate (ORR) is defined as percentage of patients with a best response being either complete response \[CR\] or partial response \[PR\] during treatment. ORR will be assessed in each study arm. |
| Secondary | To evaluate the efficacy of treatment sequence (R-TT or TT-R) in terms of the Time-to-treatment failure 1 (TTF1) | Expected duration of 3 months from randomization | Time-to-treatment failure 1 (TTF1) is defined as the time from randomization to treatment discontinuation for any reason (including disease progression, treatment toxicity, patient preference, or death) during the first sequence of treatment in each arm. |
| Secondary | To evaluate the efficacy of treatment sequence (R-TT or TT-R) in terms of the Time-to-treatment failure 2 (TTF2) | Expected duration of 6 months from randomization | Time-to-treatment failure 2 (TTF2) is defined as the time from randomization to treatment discontinuation for any reason (including disease progression, treatment toxicity, patient preference, or death) during the second sequence of treatment in each arm. |
| Secondary | To evaluate the health-related quality of life of cancer patients during treatment | Expected 30 days after last study treatment administration, up to 5 years | Quality of life data using the patient reported outcomes, quality of life questionnaire - Core 30 (QLQ-C30) version 3.0 will be collected during the study. Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. |
| Secondary | To evaluate the performance status deterioration | Expected 30 days after last study treatment administration, up to 5 years | The time to Eastern Cooperative Oncology Group performance status (ECOG PS) ≥2 deterioration is defined as the time interval between randomization and the first documented ECOG PS ≥2 during the study. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04450836
GET https://conductscience.org/api/trials/v1/NCT04450836/registered