Trial · NCT04625907
FaR-RMS: An Overarching Study for Children and Adults With Frontline and Relapsed RhabdoMyoSarcoma
NCT04625907, Phase 1, Phase 2, Recruiting, University of Birmingham
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. FaR-RMS: An Overarching Study for Children and Adults With Frontline and Relapsed RhabdoMyoSarcoma. Trials, record NCT04625907. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04625907
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- FaR-RMS: An Overarching Study for Children and Adults With Frontline and Relapsed RhabdoMyoSarcoma
- NCT number
- NCT04625907
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 1,672 participants, estimated
- Lead sponsor
- University of Birmingham
- Conditions
- Rhabdomyosarcoma
- Interventions
- Irinotecan, Actinomycin D, Doxorubicin, Ifosfamide, Vincristine, Vinorelbine, Cyclophosphamide, Temozolomide, radiotherapy, Regorafenib
- First posted
- 2020-11-12
- Last updated
- 2024-05-23
- Other registries' IDs
- eudract:2018-000515-24, isrctn:ISRCTN45535982
Source ClinicalTrials.gov
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 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/NCT04625907
GET https://conductscience.org/api/trials/v1/NCT04625907/registered?page=2