Trial · NCT04450836
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| 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. |
| Secondary | To evaluate the safety (Treatment-Emergent Adverse Events) during treatment | Expected 30 days after last study treatment administration, up to 5 years | Data concerning adverse events graded using the common terminology criteria for adverse events (CTCAE) v5.0 will be collected during the study. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT04450836/registered