Trial · NCT04625907
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 36
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event Free Survival (RT2) | From randomisation to first failure event, timeframe 36 months | Failure events are: * Relapse or progression of existing disease, or occurrence of disease at new sites, * Death from any cause without disease progression, * Second malignant neoplasm |
| Primary | Event Free Survival (CT1A) | From randomisation to first failure event, timeframe 36 months | Failure events are: * Relapse or progression of existing disease, or occurrence of disease at new sites, * Death from any cause without disease progression, * Second malignant neoplasm |
| Primary | Event Free Survival (CT1B) | From randomisation to first failure event, timeframe 36 months | Failure events are: * Relapse or progression of existing disease, or occurrence of disease at new sites, * Death from any cause without disease progression, * Second malignant neoplasm |
| Primary | Event Free Survival (CT2A) | From randomisation to first failure event, timeframe 36 months | Failure events are: * Relapse or progression of existing disease, or occurrence of disease at new sites, * Death from any cause without disease progression, * Second malignant neoplasm |
| Primary | Event Free Survival (CT2B) | Time from randomisation to first failure event, timeframe 36 months | Failure events are: * Relapse or progression of existing disease, or occurrence of disease at new sites, * Death from any cause without disease progression, * Second malignant neoplasm |
| Primary | Event Free Survival (CT3) | Patients will be followed up for a minimum of 6 years from trial entry (or 5 years from end of relapsed trial treatment, whichever comes later). Patients will be followed up for progression and death until the end of trial definition has been met. | To determine whether new systemic therapy regimens improve event free survival in relapsed RMS compared to standard therapy (VIRT) (CT3): Initial new systemic therapy combination to be tested: o Regorafenib (R) added to vincristine and irinotecan (VIR) (VIRR) |
| Primary | Local Failure Free Survival (RT1A and RT1B) | Time from randomisation to first local failure event, timeframe 36 months | A local failure event is relapse or progression of tumour at the primary site at any time even if there has been a prior /concurrent, regional or distant failure |
| Primary | Local Failure Free Survival (RT1C) | Time from randomisation to first local failure event, timeframe 36 months | A local failure event is relapse or progression of tumour at the primary site at any time even if there has been a prior /concurrent, regional or distant failure |
| Secondary | Recommended Phase II Dose (Phase 1b) | From first patient first visit in dose finding study until appropriate dose level found, estimated 9 months | Based on tolerability, where tolerability is evaluated through the occurrence of dose limiting toxicity (DLT). |
| Secondary | Maximum Tolerated Dose (Phase 1b) | From first patient first visit in dose finding study until appropriate dose level | Dose level at which no or one participant experiences a DLT when at least two of three to six participants experience a DLT at the next highest dose. |
| Secondary | Toxicity (All chemotherapy randomisations) | From date of protocol defined treatment until 30 days after the administration of the last treatment | Categorised and graded using Common Terminology Criteria for Adverse Events |
| Secondary | Dose Limiting Toxicity (Phase 1b) | From commencement of treatment until 21 days after the start of cycle 2 (each cycle is 21 days) | Diarrhoea: Grade 3 for \>3 days despite loperamide therapy Diarrhoea: Grade 4 despite loperamide therapy. Enterocolitis: Grade 3 or above Ileus: Grade 3 or above for more than 3 days Oral mucositis: Grade 3 above for \>3 days despite optimal supportive care Persistent neutropenia or thrombocytopenia leading to delay of start of next course by \>7 days; i.e. starting \> day 28 Any grade 3 or 4 toxicity resulting in discontinuation of the new combination Any grade 5 toxicity |
| Secondary | Response (Phase 1b, CT1A, CT1B) | Response assessed after course 3 (63 days) and 6 (126 days) | defined as complete (CR) or partial response (PR) and is clinically defined. Patients who are not assessable for response - e.g. because of early stopping of treatment or death - will be assumed to be non-responders. |
| Secondary | Tolerability (CT3) | From registration/randomisation until death/study endpoint | To determine the tolerability of the regimens. |
| Secondary | Overall Survival (CT1A) | From randomisation to death from any cause, assessed for 36 months | Death from any cause |
| Secondary | Overall Survival (CT1B) | From randomisation to death from any cause, assessed for 36 months | Death from any cause |
| Secondary | Overall Survival (CT2A) | From randomisation to death from any cause, assessed for 36 months | Death from any cause |
| Secondary | Overall Survival (CT2B) | From randomisation to death from any cause, assessed for 36 months | Death from any cause |
| Secondary | Overall Survival (RT1A and RT1B) | From randomisation to death from any cause, assessed for 36 months | Death from any cause |
| Secondary | Overall Survival (RT1C) | From RT1C randomisation to death from any cause, assessed for 36 months | Death from any cause |
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/NCT04625907/registered