Trial · NCT03665506
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall survival | Baseline up to 3 years | time from first administration of trifluridin/tipiracil to death from any cause |
| Secondary | Progression-free survival | Baseline up to 3 years | PFS: time from first administration of trifluridin/tipiracil to disease progression or death from any cause |
| Secondary | Overall response rate | Baseline up to 3 years | ORR: the proportion of patients whose best response was a complete or partial response |
| Secondary | Disease control rate 8 weeks | Baseline up to 3 years | DCR-8: the proportion of patients with a best response of complete or partial response or stable disease, with the assessment of stable disease made at least 8 weeks after first administration of trifluridin/tipiracil |
| Secondary | Trifluridin/tipiracil treatment details | Baseline | Line of Trifluridin/Tipiracil treatment (Descriptive statistics using frequency tables will be used to assess the number of prior palliative systemic antineoplastic treatment regimen) |
| Secondary | Trifluridin/tipiracil treatment details | Baseline up to 3 years | Treatment duration |
| Secondary | Trifluridin/tipiracil treatment details | Baseline up to 3 years | Dose intensity (absolute and relative) |
| Secondary | Trifluridin/tipiracil treatment details | Baseline up to 3 years | Treatment sequence (previous and subsequent therapies in relation to Trifluridin/Tipiracil treatment) (Descriptive statistics using frequency tables will be used to assess previous and subsequent palliative systemic antineoplastic treatment regimen used.) |
| Secondary | AEs and SAEs according to NCI CTCAE | Baseline up to 3 years | AEs and SAEs according to NCI CTCAE |
| Secondary | Safety laboratory values of participants | Baseline up to 3 years | By-patient display of all safety laboratory results captured as per clinical routine (e.g. CEA, CA 19-9, haemoglobin, neutrophils absolute, lymphocytes count, platelets count, leukocytes count, alkaline phosphatase, ALT (GPT), AST (GOT), bilirubin total and serum creatinine). In addition, CTCAE grades of neutrophils, white blood cell count, platelets, haemoglobin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin, alkaline phosphatase and creatinine will be presented using frequencies and percentages for each visit. Shift tables opposing CTCAE grades during treatment to baseline CTCAE grades of the mentioned parameters will also be presented per visit using frequencies and percentages. |
| Secondary | Therapy management (use of relevant supportive medications) | Baseline up to 3 years | Number of patients receiving G-CSFs for prophylaxis of chemotherapy-induced neutropenia and febrile neutropenia (Frequencies) |
| Secondary | Patient-reported outcomes (PROs) on quality of life (QoL) | Baseline up to 3 years | PRO-CTCAE: Questionnaire PRO-CTCAE is used to determine patients' symptomatic toxicity. Item cluster scores of PRO-CTCAE questionnaire at each visit and change from baseline of scores. |
| Secondary | Patient-reported outcomes (PROs) on quality of life (QoL) | Baseline up to 3 years | EQ-5D-5L: Questionnaire EQ-5D-5L is used to determine patients' health related quality of life. EQ-5D-5L index and visual analogue score at each visit and change from baseline for both, index and visual analogue score. |
| Other | Time to deterioration of the ECOG performance status | Baseline up to 3 years | |
| Other | Assessment of health economic parameters | Baseline up to 3 years | Incidence of hospitalization (Frequencies) |
| Other | Assessment of health economic parameters | Baseline up to 3 years | Frequency of hospitalization (Frequencies) |
| Other | Assessment of health economic parameters | Baseline up to 3 years | Total duration of hospital stays per patient (descriptive statistics) |
| Other | Assessment of health economic parameters | Baseline up to 3 years | Reasons for hospitalizations per patient and per case (Frequencies) |
| Other | Assessment of health economic parameters | Baseline up to 3 years | Number of consultations of various medical specialists |
| Other | Assessment of health economic parameters | Baseline up to 3 years | Incidence of home care (Frequencies) |
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/NCT03665506/registered