Trial · NCT07213570
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 | Progression Free Survival rate at 6 months in the two arms. | up to 6 months from randomization | Progression Free Survival rate at 6 months(PFS rate at 6-months) is defined as the rate of assessable patients alive and not progressed after 6 months from study initiation (i.e randomization) to the first documentation of objective disease progression by RECIST 1.1 criteria, or death due to any cause, whichever occurs first. |
| Secondary | Progression free survival (PFS) | up to 1 year last patients randomized | Progression free survival (PFS) calculated as the time from randomization until the date of death from any cause until the date of the first observation of disease progression or death due to any cause, whichever occurs first. |
| Secondary | Overall survival (OS) | up to 1 year last patients randomized | Overall survival (OS) calculated as the time from randomization until the date of death from any cause. |
| Secondary | Objective Tumor Response Rate (ORR) | up to 1 year last patients randomized | Objective Tumor Response Rate (ORR) assessed according to RECIST criteria 1.1, as the proportion of patients achieving complete or partial response relative to total enrolled patients. |
| Secondary | Disease Control Rate (DCR) | up to 1 year last patients randomized | Disease Control Rate (DCR) defined as the proportion of patients with complete/partial response and stable disease as their best response |
| Secondary | Progression free survival 2 (PFS2) | up to 1 year last patients randomized | Progression free survival 2 (PFS2) calculated as the time from registration to progression from subsequent line of treatment or death without progression, whichever occurred first. |
| Secondary | Overall Toxicity rate | up to 1 year last patients randomized | Overall Toxicity rate defined as adverse events graded according NCI CTCAE v 5.0. as the proportion of patients experiencing any grade AE accordingly to the NCI Common Terminology Criteria of Adverse Events (NCI CTC-AE) Version 5, relative to the total of patients receiving at least one cycle of treatment.AE will be listed individually by the patient and summarized overall (severity grades 1-4) and for grade ≥3 by treatment received. |
| Secondary | Quality of life (QoL) | questionnaires must be completed before any study procedure but within 2 weeks prior to randomization (baseline) and thereafter every 8 weeks from randomization until disease progression, treatment failure or death, assessed up to 18 months | Quality of life (QoL) investigated through the EORTC QOL-C30 questionnaires at baseline (prior to treatment start, once eligibility is confirmed) and every 8 weeks from randomization until disease progression, treatment failure or death. |
| Secondary | Quality of life (QoL) | questionnaires must be completed before any study procedure but within 2 weeks prior to randomization (baseline) and thereafter every 8 weeks from randomization until disease progression, treatment failure or death, assessed up to 18 months. | Quality of life (QoL) investigated through the EORTC QOL-CR29 questionnaires at baseline (prior to treatment start, once eligibility is confirmed) and every 8 weeks from randomization until disease progression, treatment failure or death. |
| Secondary | PRO-CTCAE | questionnaires must be completed before any study procedure but within 2 weeks prior to randomization (baseline) and thereafter every 8 weeks from randomization until disease progression, treatment failure or death, assessed up to 18 months. | PRO-CTCAE questionnaires will be administered at the same time points with items dedicated in particular to Hand-Foot Syndrome and Hand-Foot skin reactions, diarrhea and neuropathy, to better evaluate the effect of two different strategies of treatment on the health-related QoL. |
| Secondary | Financial toxicity assessed through the PROFFIT questionnaire | at baseline (prior to treatment start, once eligibility is confirmed) and every 8 weeks from randomization until disease progression, treatment failure or death, assessed up to 18 months. | Financial toxicity assessed through the PROFFIT questionnaire at baseline (prior to treatment start, once eligibility is confirmed) and every 8 weeks from randomization until disease progression, treatment failure or death. |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07213570/registered