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
باختصار
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…
المرحلة 3مطلوب 205 مشاركين181 موقعاً4 دول
الفئات
مسجَّلة في سجل واحد
- ClinicalTrials.govNCT05304585فتح هذا السجل في ClinicalTrials.govتمت المزامنة قبل 4 أسابيع
يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.
تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.
هل أنت مهتم بهذه الدراسة؟
تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.
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.
ملخص
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.
الحالات
- Embryonal Rhabdomyosarcoma
- Fusion-Negative Alveolar Rhabdomyosarcoma
- Spindle Cell/Sclerosing Rhabdomyosarcoma
الأهلية
| الجنس | الجميع |
|---|---|
| الأعمار | لا حد أدنى – 21 Years |
| المتطوعون الأصحّاء | لا |
الأهلية كما كُتبت في السجل
الأهلية في عبارات بسيطة
لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.
تصميم الدراسة
| نوع الدراسة | تدخّلية |
|---|---|
| المرحلة | المرحلة 3 |
| التخصيص | غير معشّاة |
| نموذج التدخّل | PARALLEL |
| الغرض الأساسي | TREATMENT |
| التعمية | NONE (0) |
| التجنيد | مطلوب 205 مشاركين |
الجهة الراعية والمتعاونون
- Children's Oncology Group الجهة الراعية
- National Cancer Institute (NCI) المتعاونون
الأذرع والتدخلات
- 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.
التدخلات
- إجراء Biopsy Procedure
Undergo tumor biopsy
- إجراء Bone Scan
Undergo bone scan
- إجراء Computed Tomography
Undergo CT scan
- دواء Cyclophosphamide
Given IV
- منتج بيولوجي Dactinomycin
Given IV
- إجراء Magnetic Resonance Elastography
Undergo MRI
- إجراء Positron Emission Tomography
Undergo PET scan
- إشعاع Radiation Therapy
Undergo radiation
- دواء Vincristine
Given IV
مقاييس النتائج
مقياس النتيجة الأولي
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.
الإطار الزمني From study enrollment to disease progression, recurrence, or death as a first event, assessed up to 3 years
مقياس النتيجة الأولي
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.
الإطار الزمني From study enrollment to disease progression, recurrence, or death as a first event, assessed up to 3 years
مقياس النتيجة الثانوي
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.
الإطار الزمني From study entry to death of any cause, assessed up to 5 years
مقياس النتيجة الثانوي
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.
الإطار الزمني From study entry to death of any cause, assessed up to 5 years
مقياس النتيجة الثانوي
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.
الإطار الزمني Up to 24 weeks
مقياس نتيجة آخر
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.
الإطار الزمني Up to 5 years
مقياس نتيجة آخر
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.
الإطار الزمني Up to 5 years
التواريخ
| تاريخ البدء | 4 أغسطس 2022 (فعلي) |
|---|---|
| الإتمام الأولي | 30 يونيو 2030 (تقديري) |
| الإتمام | 30 يونيو 2030 (تقديري) |
| أول نشر | 31 مارس 2022 (فعلي) |
| آخر تحديث | 25 أغسطس 2026 |
| النتائج منشورة | غير مذكور في سجل السجل |
| آخر تأكيد للحالة | أكتوبر 2025 |
فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.
المواقع
178 موقعاً قيد التجنيد
Australia
| المنشأة | المدينة | الولاية أو المنطقة | الحالة |
|---|---|---|---|
| Perth Children's Hospital | Perth | Western Australia | قيد التجنيد |
| Sydney Children's Hospital | Randwick | New South Wales | قيد التجنيد |
| The Children's Hospital at Westmead | Westmead | New South Wales | قيد التجنيد |
Canada
| المنشأة | المدينة | الولاية أو المنطقة | الحالة |
|---|---|---|---|
| Alberta Children's Hospital | Calgary | Alberta | قيد التجنيد |
| University of Alberta Hospital | Edmonton | Alberta | قيد التجنيد |
| IWK Health Centre | Halifax | Nova Scotia | قيد التجنيد |
| Centre Hospitalier Universitaire Sainte-Justine | Montreal | Quebec | قيد التجنيد |
| The Montreal Children's Hospital of the MUHC | Montreal | Quebec | قيد التجنيد |
| CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) | Québec | قيد التجنيد | |
| Centre Hospitalier Universitaire de Sherbrooke-Fleurimont | Sherbrooke | Quebec | مُعلَّق |
| Hospital for Sick Children | Toronto | Ontario | قيد التجنيد |
| British Columbia Children's Hospital | Vancouver | British Columbia | قيد التجنيد |
| CancerCare Manitoba | Winnipeg | Manitoba | قيد التجنيد |
New Zealand
| المنشأة | المدينة | الولاية أو المنطقة | الحالة |
|---|---|---|---|
| Christchurch Hospital | Christchurch | قيد التجنيد | |
| Starship Children's Hospital | Grafton | Auckland | قيد التجنيد |
United States
| المنشأة | المدينة | الولاية أو المنطقة | الحالة |
|---|---|---|---|
| Children's Hospital Medical Center of Akron | Akron | Ohio | قيد التجنيد |
| Albany Medical Center | Albany | New York | قيد التجنيد |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | قيد التجنيد |
| Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania | قيد التجنيد |
| C S Mott Children's Hospital | Ann Arbor | Michigan | قيد التجنيد |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital | Atlanta | Georgia | قيد التجنيد |
| Children's Hospital Colorado | Aurora | Colorado | قيد التجنيد |
| Dell Children's Medical Center of Central Texas | Austin | Texas | قيد التجنيد |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | قيد التجنيد |
| Sinai Hospital of Baltimore | Baltimore | Maryland | قيد التجنيد |
| University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | قيد التجنيد |
| Children's Hospital of Alabama | Birmingham | Alabama | قيد التجنيد |
| Saint Luke's Cancer Institute - Boise | Boise | Idaho | قيد التجنيد |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | قيد التجنيد |
| Dana-Farber Cancer Institute | Boston | Massachusetts | قيد التجنيد |
| Roswell Park Cancer Institute | Buffalo | New York | قيد التجنيد |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | قيد التجنيد |
| West Virginia University Charleston Division | Charleston | West Virginia | قيد التجنيد |
| Medical University of South Carolina | Charleston | South Carolina | قيد التجنيد |
| Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | قيد التجنيد |
| Novant Health Presbyterian Medical Center | Charlotte | North Carolina | قيد التجنيد |
| University of Virginia Cancer Center | Charlottesville | Virginia | قيد التجنيد |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | قيد التجنيد |
| University of Illinois | Chicago | Illinois | مُعلَّق |
| Lurie Children's Hospital-Chicago | Chicago | Illinois | قيد التجنيد |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | قيد التجنيد |
| Cleveland Clinic Foundation | Cleveland | Ohio | قيد التجنيد |
| Rainbow Babies and Childrens Hospital | Cleveland | Ohio | قيد التجنيد |
| Prisma Health Richland Hospital | Columbia | South Carolina | قيد التجنيد |
| Nationwide Children's Hospital | Columbus | Ohio | قيد التجنيد |
| Driscoll Children's Hospital | Corpus Christi | Texas | قيد التجنيد |
| Medical City Dallas Hospital | Dallas | Texas | قيد التجنيد |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | قيد التجنيد |
| Geisinger Medical Center | Danville | Pennsylvania | قيد التجنيد |
| Dayton Children's Hospital | Dayton | Ohio | قيد التجنيد |
يُدرَج 131 موقعاً إضافياً في سجل السجل.
مستندات الدراسة
لا تُرتبط أي مستندات في سجل السجل هذا.
التغيّرات عبر الزمن
- 25 أغسطس 2026
أُضيف موقع
1 site added (181 total)
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