NCT05304585ClinicalTrials.gov
Chemotherapy for the Treatment of Patients With Newly Diagnosed Very Low-Risk and Low Risk Fusion Negative Rhabdomyosarcoma
A Prospective Phase 3 Study of Patients With Newly Diagnosed Very Low-Risk and Low-Risk Fusion Negative Rhabdomyosarcoma
בקצרה
Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment…
שלב 3דרושים 205 משתתפים181 אתרים4 מדינות
קטגוריות
רשום במרשם אחד
- ClinicalTrials.govNCT05304585פתיחת רשומה זו ב־ClinicalTrials.govסונכרן לפני 4 שבועות
מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.
מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.
מתעניינים במחקר הזה?
התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.
How this study is set up
The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.
- Present: Registered before enrolment beganFirst posted 2022-03-31; recorded start 2022-08-04
- Present: Has a defined primary outcomeA primary outcome measure is listed in the record
- Present: The primary outcome states a time frameThe primary outcome measure records a time frame
- Not stated: Participants are not randomly assignedAllocation is recorded as non-randomised
- Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
- Not stated: Open label (no blinding)Masking is recorded as none (open label)
- Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
- Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
- Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
- Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
- Present: Sponsor has 183 other studies in this databaseCounted from the lead sponsor named in the record (Children's Oncology Group)
- Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
- The record lists 3 conditions.
- Lead sponsor type recorded as: research network.
- Intervention regulatory context: investigational, within a phased regulatory pathway.
Trial stature
Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.
An exploratory-stage design for a phase 3 study, judged from its ClinicalTrials.gov record.
How this score is built
- Randomised allocation0/20
Non-randomised allocation
- Blinding0/20
Open-label
- Control arm0/15
No comparator arm stated in the record
- Primary-outcome specificity10/10
Named primary outcome with a defined time frame
- Endpoint type10/10
Mortality / MACE endpoint (hard clinical outcome)
- Multi-centre8/8
Multi-centre: 180 sites
- Data monitoring committee0/7
No data monitoring committee stated
- Prospective registration5/5
Registered before the study start date
- Protocol / SAP posted0/5
No protocol or SAP posted to the registry
A medium-sized study, international in scope: 205 participants (target), run at 181 sites, across 4 countries.
How this score is built
- Enrolment22/40
205 participants (target)
- Site count25/25
180 sites
- Country count7/15
4 countries
- Planned duration10/10
Planned over about 96 months
- Sponsor scale9/10
Children's Oncology Group has led 182 trials in our corpus
We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.
How this score is built
- Investigator standing0/100
No investigator recorded in the registry for this trial
These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.
תקציר
Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma. Another aim of the study it to find out how well patients with low risk rhabdomyosarcoma (LR-RMS) respond to standard chemotherapy when patients with VLR-RMS and patients who have rhabdomyosarcoma with DNA mutations get separate treatment. Finally, this study examines the effect of therapy intensification in patients who have RMS cancer with DNA mutations to see if their outcomes can be improved.
מצבים רפואיים
- Embryonal Rhabdomyosarcoma
- Fusion-Negative Alveolar Rhabdomyosarcoma
- Spindle Cell/Sclerosing Rhabdomyosarcoma
זכאות
| מין | הכול |
|---|---|
| גילאים | ללא מינימום – 21 Years |
| מתנדבים בריאים | לא |
זכאות כפי שנכתבה במרשם
זכאות במשפטים פשוטים
הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.
תכנון המחקר
| סוג המחקר | התערבותי |
|---|---|
| שלב | שלב 3 |
| הקצאה | לא אקראי |
| מודל ההתערבות | PARALLEL |
| מטרה ראשית | TREATMENT |
| הסתרה | NONE (0) |
| גיוס | דרושים 205 משתתפים |
נותן חסות ושותפים
- Children's Oncology Group נותן חסות
- National Cancer Institute (NCI) שותפים
זרועות והתערבויות
- Regimen M (positive mutation)EXPERIMENTAL
Patients receive vincristine IV on day 1 of each cycle and days 8 and 15 of cycles 2-4, 7-8, and 11-12 and dactinomycin IV over 1-5 minutes or 10-15 minutes on day 1 of cycles 2-5 and 8-14. Patients also receive cyclophosphamide IV over 60 minutes on day 1 of each cycle. Treatment repeats every 21 days for 12-13 cycles in the absence of disease progression or unacceptable toxicity. Patients may also undergo radiation therapy at cycle 5. Patients undergo CT scan, MRI, bone scan, PET scan and tumor biopsy throughout the study.
- Regimen VA (VLR RMS)EXPERIMENTAL
Patients with VLR RMS receive vincristine intravenously (IV) on day 1 of each cycle and days 8 and 15 of cycles 1, 3, 5, and 7 and dactinomycin IV over 1-5 minutes or over 10-15 minutes on day 1 of each cycle. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients with MYOD1 or TP53 mutated tumors transition to Regimen M at cycle 2 (if mutation status is determined to be positive at week 3) or cycle 3 (if mutation status is determined to be positive after week 3). Patients undergo CT scan, MRI, bone scan, PET scan and tumor biopsy throughout the study.
- Regimen VAC/VA (VL RMS)EXPERIMENTAL
Patients with LR RMS receive vincristine IV on day 1 of each cycle and days 8 and 15 of cycles 1-3. Patients also receive dactinomycin IV over 1-5 minutes or 10-15 minutes and cyclophosphamide IV over 60 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive vincristine IV on day 1 of each cycle and days 8 and 15 of cycles 5-7 and dactinomycin IV over 1-5 minutes or over 10-15 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with MYOD1 or TP53 mutated tumors transition to Regimen M at cycle 2 (if mutation status is determined to be positive at week 3) or cycle 3 (if mutation status is determined to be positive after week 3). Radiation therapy (if needed) will be administered at cycle 5.Patients undergo CT scan, MRI, bone scan, PET scan and tumor biopsy throughout the study.
התערבויות
- פרוצדורה Biopsy Procedure
Undergo tumor biopsy
- פרוצדורה Bone Scan
Undergo bone scan
- פרוצדורה Computed Tomography
Undergo CT scan
- תרופה Cyclophosphamide
Given IV
- ביולוגי Dactinomycin
Given IV
- פרוצדורה Magnetic Resonance Elastography
Undergo MRI
- פרוצדורה Positron Emission Tomography
Undergo PET scan
- קרינה Radiation Therapy
Undergo radiation
- תרופה Vincristine
Given IV
מדדי תוצאה
מדד תוצאה ראשוני
Failure free survival (FFS) for very low risk patients
The Kaplan-Meier method will be used to estimate 3-year FFS along with 80% log-minus-log transformed confidence limits for very low risk (VLR) patients.
מסגרת זמן From study enrollment to disease progression, recurrence, or death as a first event, assessed up to 3 years
מדד תוצאה ראשוני
Failure free survival (FFS) for low risk patients
The Kaplan-Meier method will be used to estimate 3 year FFS along with 80% log-minus-log transformed confidence limits for low risk (LR) patients.
מסגרת זמן From study enrollment to disease progression, recurrence, or death as a first event, assessed up to 3 years
מדד תוצאה משני
Overall survival (OS) for very low risk patients
Log-rank test will be used to compare the OS of patients with VLR rhabdomyosarcoma (RMS) treated with 24 weeks of vincristine, dactinomycin (VA) to the VLR RMS patients from ARST0331 and D9602 with the same inclusion criteria.
מסגרת זמן From study entry to death of any cause, assessed up to 5 years
מדד תוצאה משני
Overall survival (OS) for low risk patients
Log-rank test will be used to compare the OS from LR RMS patients to LR RMS patients from ARST0331 and D9602 with the same inclusion criteria.
מסגרת זמן From study entry to death of any cause, assessed up to 5 years
מדד תוצאה משני
Feasibility of central molecular risk stratification of patients assessed by the percentage of patients who have molecular testing results returned by 6 weeks
If the percentage of patients who have molecular testing results returned by 6 weeks is \>= 80% then the central molecular risk stratification is considered feasible.
מסגרת זמן Up to 24 weeks
מדד תוצאה אחר
Methylation array profile of patients with fusion negative, low-risk rhabdomyosarcoma
Summary statistics will be used to describe the methylation array profile of patients with fusion negative, low-risk rhabdomyosarcoma. Correlation between methylation patterns and clinical presentation, histology, and genetics will be evaluated.
מסגרת זמן Up to 5 years
מדד תוצאה אחר
Descriptive analysis of patients treated on Regimen M
Summary statistics will be used to provide a descriptive analysis of patients treated on Regimen M, including patient demographics, clinical characteristics and outcomes.
מסגרת זמן Up to 5 years
תאריכים
| תאריך התחלה | 4 באוגוסט 2022 (בפועל) |
|---|---|
| סיום ראשוני | 30 ביוני 2030 (משוער) |
| סיום | 30 ביוני 2030 (משוער) |
| פורסם לראשונה | 31 במרץ 2022 (בפועל) |
| עודכן לאחרונה | 25 באוגוסט 2026 |
| התוצאות פורסמו | לא צוין ברשומת המרשם |
| המצב אומת לאחרונה | אוקטובר 2025 |
בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.
מיקומים
178 אתרים מגייסים
Australia
| מתקן | עיר | מדינה או אזור | מצב |
|---|---|---|---|
| Perth Children's Hospital | Perth | Western Australia | מגייס |
| Sydney Children's Hospital | Randwick | New South Wales | מגייס |
| The Children's Hospital at Westmead | Westmead | New South Wales | מגייס |
Canada
| מתקן | עיר | מדינה או אזור | מצב |
|---|---|---|---|
| Alberta Children's Hospital | Calgary | Alberta | מגייס |
| University of Alberta Hospital | Edmonton | Alberta | מגייס |
| IWK Health Centre | Halifax | Nova Scotia | מגייס |
| Centre Hospitalier Universitaire Sainte-Justine | Montreal | Quebec | מגייס |
| The Montreal Children's Hospital of the MUHC | Montreal | Quebec | מגייס |
| CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) | Québec | מגייס | |
| Centre Hospitalier Universitaire de Sherbrooke-Fleurimont | Sherbrooke | Quebec | מושהה |
| Hospital for Sick Children | Toronto | Ontario | מגייס |
| British Columbia Children's Hospital | Vancouver | British Columbia | מגייס |
| CancerCare Manitoba | Winnipeg | Manitoba | מגייס |
New Zealand
| מתקן | עיר | מדינה או אזור | מצב |
|---|---|---|---|
| Christchurch Hospital | Christchurch | מגייס | |
| Starship Children's Hospital | Grafton | Auckland | מגייס |
United States
| מתקן | עיר | מדינה או אזור | מצב |
|---|---|---|---|
| Children's Hospital Medical Center of Akron | Akron | Ohio | מגייס |
| Albany Medical Center | Albany | New York | מגייס |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | מגייס |
| Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania | מגייס |
| C S Mott Children's Hospital | Ann Arbor | Michigan | מגייס |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital | Atlanta | Georgia | מגייס |
| Children's Hospital Colorado | Aurora | Colorado | מגייס |
| Dell Children's Medical Center of Central Texas | Austin | Texas | מגייס |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | מגייס |
| Sinai Hospital of Baltimore | Baltimore | Maryland | מגייס |
| University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | מגייס |
| Children's Hospital of Alabama | Birmingham | Alabama | מגייס |
| Saint Luke's Cancer Institute - Boise | Boise | Idaho | מגייס |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | מגייס |
| Dana-Farber Cancer Institute | Boston | Massachusetts | מגייס |
| Roswell Park Cancer Institute | Buffalo | New York | מגייס |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | מגייס |
| West Virginia University Charleston Division | Charleston | West Virginia | מגייס |
| Medical University of South Carolina | Charleston | South Carolina | מגייס |
| Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | מגייס |
| Novant Health Presbyterian Medical Center | Charlotte | North Carolina | מגייס |
| University of Virginia Cancer Center | Charlottesville | Virginia | מגייס |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | מגייס |
| University of Illinois | Chicago | Illinois | מושהה |
| Lurie Children's Hospital-Chicago | Chicago | Illinois | מגייס |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | מגייס |
| Cleveland Clinic Foundation | Cleveland | Ohio | מגייס |
| Rainbow Babies and Childrens Hospital | Cleveland | Ohio | מגייס |
| Prisma Health Richland Hospital | Columbia | South Carolina | מגייס |
| Nationwide Children's Hospital | Columbus | Ohio | מגייס |
| Driscoll Children's Hospital | Corpus Christi | Texas | מגייס |
| Medical City Dallas Hospital | Dallas | Texas | מגייס |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | מגייס |
| Geisinger Medical Center | Danville | Pennsylvania | מגייס |
| Dayton Children's Hospital | Dayton | Ohio | מגייס |
131 אתרים נוספים מצוינים ברשומת המרשם.
מסמכי המחקר
לא צורפו מסמכים ברשומת מרשם זו.
שינויים לאורך זמן
- 25 באוגוסט 2026
אתר נוסף
1 site added (181 total)
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