Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04994132 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.
MinorCompletion pushed from Jun 30, 2026 to Jul 1, 2027Enrollment target: estimated 118 to confirmed 113 · Study sites revised (250)v44Show 2 more changesShow less
NotablePrimary endpoint revisedEligibility criteria revised · Secondary endpoints: 4 to 6 · Study description expanded, about 40 wordsv36Show 3 more changesShow less
NotableTrial status: Active, Not Recruiting to RecruitingSite details revised at 192 of 192 sitesv11Show 1 more changeShow less
Site details revised at 192 of 192 sites
MinorRe-verified, no change to tracked fieldsv10
MinorPrimary and study completion dates: Mar 31, 2028 to Jun 30, 2028Secondary endpoints: details revised at 1 of 4 entriesv9Show 1 more changeShow less
Secondary endpoints: details revised at 1 of 4 entries
NotableEnrollment target: 100 to 8Primary and study completion dates: Jan 15, 2027 to Mar 31, 2028 · Eligibility criteria expanded, about 18 words · Secondary endpoints: details revised at 3 of 4 entries · 3 morev7Show 6 more changesShow less
Primary and study completion dates: Jan 15, 2027 to Mar 31, 2028
Eligibility criteria expanded, about 18 words
Secondary endpoints: details revised at 3 of 4 entries
MinorTrial status: Recruiting to Active, Not RecruitingSite details revised at 55 of 55 sitesv5Show 1 more changeShow less
Site details revised at 55 of 55 sites
MinorStudy sites: 9 to 55v4
NotableTrial status: Not Yet Recruiting to RecruitingStart date changed from estimate of Sep 14, 2021 to Sep 13, 2021 · Site details revised at 9 of 9 sites · Collaborators expanded, about 4 wordsv3Show 3 more changesShow less
Start date changed from estimate of Sep 14, 2021 to Sep 13, 2021
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase III trial compares the safety and effect of adding vinorelbine to vincristine, dactinomycin, and cyclophosphamide (VAC) for the treatment of patients with high risk rhabdomyosarcoma (RMS). High risk refers to cancer that is likely to recur (come back) after treatment or spread to other parts of the body. This study will also examine if adding maintenance therapy after VAC therapy, with or without vinorelbine, will help get rid of the cancer and/or lower the chance that the cancer comes back. Vinorelbine and vincristine are in a class of medications called vinca alkaloids. They work by stopping cancer cells from growing and dividing and may kill them. Dactinomycin is a type of antibiotic that is only used in cancer chemotherapy. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Vinorelbine, vincristine, dactinomycin and cyclophosphamide are chemotherapy medications that work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may have the potential to eliminate rhabdomyosarcoma for a long time or for the rest of patient's life.